Your ability to recruit patients - to identify the most qualified patients, to make enrollment as simple and seamless as possible, and to provide support from application to randomization - is the major determinant to whether or not you will be able run your trial on schedule and without running over budget.
In fact, delays in patient recruitment are strikingly common across the clinical research industry; 80% of clinical trials do not meet their designated patient enrollment deadlines. This, of course, significantly impacts the time that it takes to bring new medicines into the hands of patients that need them.
It is important to accurately estimate how great of a challenge patient recruitment is likely to be for your unique trial, and to develop strategies for success in this area early on when designing the trial.
While you can certainly leave patient recruitment to be done in-house, outsourcing this vital process to an experienced team within the clinical trial recruitment space not only tends to be more cost-effective, but also increases your chances of success by freeing up your own team’s resources to focus on the vital research and clinical operations of the study.
At Clara Health, we built our platform to specialize in the patient recruitment of rare and sensitive patient populations.
1. M&B Sciences, Inc. (Formerly Clara Health)
M&B Sciences, Inc., a San Diego-based technology firm, has acquired Clara Health. They are now a single entity, and Clara Health’s services are available through M&B Sciences, Inc.
Clara Health’s expertise is in providing patient-centric, end-to-end patient recruitment and retention solutions for traditional, hybrid, and decentralized clinical trials.
Clara can access 98% of all web traffic to enroll a representative and diverse patient population. This scale is supplemented by partnerships with patient advocacy groups and our own in-house patient advocacy group, the Breakthrough Crew.
To ensure any interested trial applicant has maximum chance at success, Clara’s enrollment platform supports applicants from initial screening through enrollment. This technology, along with the scale of our recruitment capabilities, have accelerated study accrual timelines by up to 400% for sponsors and CROs.
Some ClaraCare services include: 24/7 live support for participants and study sites, compensation and reimbursement management, full service travel booking and coordination, EMR collection and screening, and more.
AutoCruitment is a patient recruitment agency that utilizes 1500+ digital channels to reach and randomize patients for clinical trials. They have built a unique platform that helps to target, recruit, screen and refer patients for clinical trials.
The company works to help with patient recruitment for clinical trials in all phases, as well as for medical device trials. Some features that AutoCruitment offers include risk-based pricing, and a 3-day startup time.
AutoCruitment mentions on their website that their approach helps to accelerate recruitment timelines by an average of 72%, which is equivalent to 5 months on enrollment timelines.
Clariness offers over 15 years of experience in patient recruitment and engagement. One of the core offerings of this company is its global patient portal for clinical trials ClinLife®, which gathers 40+ million global visitors per year. It is available in more than 50 countries, with top patient visitors coming from countries including Poland, Colombia, Great Britain, Germany, Brazil, Hungary, US, the Czech Republic and Ukraine.
Antidote is a clinical trial patient recruitment company that works with more than 300 health non-profit organizations and patient advocates to connect patients to clinical studies.
Some of its offerings include targeted outreach through its network of partners and patient advocacy groups, lab-validated referrals, and clinical trial site support.
5. BBK Worldwide
BBK Worldwide has over 35 years of experience in patient recruitment for clinical trials. The company’s suite of solutions focuses on educating and engaging patients, unburdening sites, and supporting sponsors.
In addition, this company offers a Patient Experience Management System branded as TrialCentralNet® (or TCN®), which assists sponsors with the management, enrollment and engagement of patients throughout their entire clinical trial experience.
ClinicalConnection runs a PatientEdge™ Study Participant Database that notifies patients of new clinical trials. It is a free to use database, and more than 750,000 individuals have enrolled to receive notifications over the last 12 years that the company has been in business.
Some of its offerings include study listings search feature for patients, digital omni-channel advertising of premium listings for sponsors, and web development for study landing page optimization. ClinicalConnection supports clinical studies both in the U.S. and internationally.
7. Worldwide Clinical Trials
Worldwide Clinical Trials has been in the business of patient recruitment and clinical trials management for over 30 years, and has managed trials in more than 60 countries, with a focus on improving the patient experience.
While patient recruitment is only one of its services, the company specializes in managing early and late-stage research services that include protein binding and pharmacoeconomic modeling for pharmaceutical and biotechnology companies.
8. Clinical Site Services (CCSi)
Clinical Site Services (CCSi) works with study sponsors and CROs to develop and implement patient recruitment and enrollment solutions. This company has a niche focus on patient recruitment, which also includes patient retention.
Some of its service offerings include patient recruitment and engagement through digital and traditional media placements, site support, as well as software to track patients as they move through the recruitment funnel.
Based out of Miami, Florida, Biorasi has been in the business of clinical trials since 2002, with a focus on patient recruitment and trial optimization.
The therapeutic areas that the company tailors its solutions for include: rare diseases, neurology, nephrology, oncology, regenerative medicine, dermatology and digital therapeutics. Some of its main service offerings include patient recruitment, decentralized clinical trials, COVID-19 trials, and program optimization.
10. Elligo Health Research
Elligo Health Research primarily focuses on patient recruitment as its core service offering. The company assists in randomizing patients for traditional, hybrid and decentralized clinical trials.
Elligo Health Research has partnerships with over 100 community-based healthcare practices, which enables the company to bring clinical trial opportunities to around 100 million patients.
11. Curavit Clinical Research
Curavit Clinical Research offers a digital site solution for sponsors looking to conduct decentralized trials.
The company is able to provide patient recruitment services, as well as design and management of the study on its platform which supports remote monitoring.
PatientEvolution has created several proprietary technologies and services in order to help researchers recruit qualifying patients to participate in clinical trials. Some of these solutions include PatientCircuit, PatientVisibility, PatientBlast, and PatientDial.
In addition, PatientEvolution also develops a range of educational resources, which are used by the clinical team to help patients learn about what to expect from the study, which improves patient compliance.
Clintec (an IQVIA company) is a global company that provides functional service support to sponsors and CROs in conducting clinical research. The company has been in business for 22 years and has offices in 49 countries.
Clintec services many major therapeutic disciplines, including oncology, rare diseases, autoimmune diseases, and diabetes. The solutions that the company offers are custom and depend on the nature of the clinical trial.
Veristat is a global CRO with more than 26 years of experience in clinical trial planning and execution. The company has a wide range of service offerings, which also include patient recruitment.
Some other services include full service support, strategic and regulatory consulting, project management, and medical writing.
Praxis is an agency that is niched in patient recruitment for clinical trials. The company brings to table over 18 years of experience, and uses multiple digital and offline channels to recruit patients.
Some additional services that the company offers include project management, protocol feasibility, and site relations management. In addition, Praxis also offers an in-house clinical trial data management tool PraxisDirect®, that offers sponsors and sites insights into enrollment date, performance and other metrics related to recruitment.
MMG is a global and full-service health communications company that specializes in patient recruitment and patient retention.
Some of its service offerings include: patient recruitment and engagement strategy design and program optimization.
Founded in 2014, Science37 specializes in virtual (also known as decentralized) clinical trials. The company has built a platform to host and conduct virtual clinical trials. Science37 acts as a digital site with the capability to monitor and engage patients without needing to travel to a physical site, which has potential benefits for accelerating recruitment timelines and increasing the diversity of patients.
StudyKik is a full-service patient recruitment agency that engages, recruits, enrolls and retains patients. The company has been operating since 2013, and leverages the use of technology and social media to reach its patients.
Within the last 7 years, StudyKik has reached over 6 million patients and connected over 3.1 million patients to clinical trials.
Some of its service offerings include: free-to-use study search platform, patient recruitment strategy consulting and implementation, as well as customized app technologies.
Acurian has over two decades of experience within the clinical trial recruitment industry. At the center of the company’s methodology to recruitment is their patient-first approach.
Some therapeutic areas of focus include: cardiovascular, CNS, dermatology, endocrinology, gastroenterology, men’s/women’s health, musculoskeletal, oncology, respiratory and urology.
Its service offerings focus entirely on patient recruitment, and include patient engagement and patient retention.
The company offers three levels of study support which include (1) optimized enrollment, (2) site services solution with optimized enrollment, and (3) combined enrollment, site services solution, and core CRO services.
Founded in 2014, TrialSpark is a healthcare technology company that accelerates patient recruitment.
TrialSpark believes that the current approach that most sponsors and CROs use to run trials is inefficient and lacks effectiveness. This company utilizes both digital and traditional recruitment approaches, and the entire process is tied together with the human touch of its patient-focused study teams that engage doctors, sponsors and patients.
ThreeWire is an international patient recruitment agency with offices in Minneapolis and Frankfurt, Germany. The company works with pharmaceutical, biotech and medical device industries to provide sponsors and CROs patient recruitment, enrollment and retention services through direct-to-patient marketing.
ThreeWire features a variety of case studies on its website that showcase the processes they use for recruiting patients for clinical trials.
Based in Melbourne, Australia, Trialfacts has been in the business recruiting patients for clinical trials since 2006. When working with sponsors and CROs, Trialfacts completes an analysis of the study protocol and target patient population to determine the number of patients that can be recruited, and makes a 100 percent patient recruitment guarantee.
The company shares a detailed step-by-step process for how they typically recruit patients for studies on their website.
22 Questions To Ask A Patient Recruitment Company Before Signing The Contract
1. How Far Down The Enrollment Funnel Are You Willing To Align Your Goals and Incentives With Ours?
This is one of the first questions to ask, and is fundamental to gauging whether the financial goals and incentive structures of the vendor align with what you would like to achieve, in terms of meeting timelines and hitting the minimum number of patients required for the trial to run.
Some vendors will simply refer a large volume of underqualified top of funnel volume patients, because they are charging sponsors based on metrics that don’t directly tie to their recruitment performance, such as charging based on pageviews of the trial landing page, or charging a percentage amount of the advertising budget. This performance fee arrangement may incentivize the vendor to refer as many leads as possible, without properly qualifying the applicants. This arrangement can lead to sites slowing down and becoming overwhelmed, which increases the amount of time it takes for them to respond to patient applications.
In other cases, vendors may charge hefty monthly fees while dragging behind the timeline, which isn’t going to help you run a successful trial either. This sort of financial structure isn’t based on a win-win relationship, as the vendor isn’t incentivized based on enrolled patients, but rather on earlier funnel metrics that may not actually bring in the results you’re looking for.
Without properly assessing the alignment of your and recruitment partner’s interests, you may agree to a lower financial accountability on the part of the vendor to stick to the original promise that you were sold on when signing the contract. This alignment assessment is one of the key and vital first steps in understanding exactly which performance milestones will actually “count” and which performance will not move the needle for your trial.
Clara Health: Our approach to aligning financial interests is based on success metrics, which helps to ensure a mutually beneficial partnership. From our inception, we’ve understood that trial sponsors have little interest in a massive volume of patients that most likely won’t convert into enrollments. Therefore, we never charge on top-of-funnel metrics - such as number of clicks, website visits, or completed applications - that most often will not amount to any real results that you want to see.
Instead, we bear some of the financial risk, and collect success fees on factors such as patients who complete phone screening, visit study sites for final screening, and randomize into the trial.
With this alignment, we do not win unless you do, and it incentivizes our team to explore absolutely every option, from every recruitment angle, to ensure that we deliver only the results that actually matter to you and your team.
We understand that defining key performance metrics can be a lengthy and difficult process, in and of itself. Our team can help distill your trial’s unique needs into a set of success metrics that provides a framework for analysis through the length of your recruitment efforts.
You can book your Free 30 Minute Consultation Session Here.
2. How Do You Adapt Your Recruitment Strategy When Encountering Challenges With Enrollment?
When on the hunt for the right patient recruitment partner, it is important to find a team that can understand where you are at the moment, the challenges that your team is currently confronting, and the initiatives your team already has in the works. Ultimately, the ideal partner must have the experience, the team capacity, and the technology to quickly understand the good - and the bad - of your current efforts, and augment it with their resources and capabilities.
Some of these augmentations may be their proprietary technologies, more expansive marketing strategies and reach, and authentic relationships with patient organizations in your therapeutic area.
Ideally you are looking to find a partner that can do the following four things:
- Quickly analyze your current strategy and define its shortcomings (and, do an outstanding job at it!)
- Have the ability to recruit with omni-channel marketing (blending the best of digital, traditional, and patient community channel capacities)
- Be data-driven, highly communicative, and consultative with the approach they are designing for you
- Have the capacity to get things up and running as quickly as possible if needed, without compromising the quality of their services
Patient recruitment for clinical trials has significantly changed within the last decade; this trend has only accelerated during the COVID pandemic. The result is an industry split between the “old” and “new” approaches to recruitment. Some teams remain reliant on tactics they’ve used in the past, such as putting up community flyers, or running billboard and radio ads. Others go to the other end of the spectrum and rely completely on digital recruitment strategies to enroll patients.
When teams are over-invested in one strategy versus another, or simply lack resources to address a core need for your team’s recruitment strategy, they are more incentivized to keep your attention away from that problem area, and more likely to engineer their solutions around only their core capability.
Therefore, the ideal partner for any trial is the one that can quickly identify all the areas where your team is missing out on reaching potential patients, and have the capabilities to create and execute on an action plan. The team likely has the infrastructure in place to be able to address a diverse set of recruitment challenges through a responsible, organized and data-driven approach.
In short, they should be proactive rather than reactive, consultative and not shy about highlighting the weak points of your team’s current strategy.
Clara Health: Our approach to clinical trial recruitment builds on strategies that work to drive results that matter, as quickly as possible.
Clara Health augments traditional recruitment with stellar digital and patient advocacy-driven recruitment, giving your trial the absolute best shot to meet your recruitment timelines and the required number of patients. And because of our diverse in-house capabilities, we can generate the content, marketing materials, and partnerships that are necessary to take a plan from paper into production.
This modern, ultra-targeted omni-channel marketing approach allows us to successfully help sponsors recruit for some of the most challenging rare disease clinical trials, making it possible to consistently deliver exceptional results for our current and past partners.
3. What Communication Can We Expect Between Your Team And Our Team?
It is quite important to understand what the communication expectations are, because you will be working with the partner of your choice for the duration of the recruitment phase of your trial. The partnership may last even longer if the team is also able to provide patient support/retention services.
Because so many factors can change rapidly during the length of a recruitment effort, the last thing your team needs to confront is a standard of communication that does not match your team’s needs and preferences.
Below we have included questions pertaining to the communication structure and reporting that we recommend you get clarification on prior to signing with a vendor:
For Communication Expectations:
- If you were to partner with them, who exactly from the company will be your main point of contact?
- How often will update meetings be hosted, and which team members will be present?
- How much advance time notice does the vendor require to make a change to the recruitment campaign?
- What information am I going to receive in recruitment update reports, and how exactly will this be done?
- How often can we expect this information to be updated?
- Would my team receive formal reports, or will I be able to access the metrics via interactive dashboards?
In general, what you are looking for in a patient recruitment vendor is a team that is consultative and is quick to respond to change, as things may be changing quite rapidly when everything is up and running. The need for this is especially visible during COVID-19, as there are unpredictable situations such as study sites shutting down with no notice, while patients are on-hold and need to be frequently engaged.
The ideal recruitment partner will be able to look at how things are going at the moment and with a consultative approach be able to tell you exactly what may happen next, along with all the possible solutions to these potential challenges. In addition, this partner must have the capacity to quickly put these plans into action, and constantly keep you in the loop as events unfold.
It is recommended that you determine what communication requirements you have, and match them against what the vendor is able to provide until finding the ideal partner. Doing this will ensure that your needs are met consistently throughout the entire process, ultimately giving you the best chance of success with your trial.
Clara Health: At Clara Health, we assign a designated project manager that is going to be the best link between our partners, study sites, and our internal team that will be facilitating the execution of recruitment and patient support services.
In all relationships, we are able to have a centralized perspective of everything that is going on throughout the duration of the trial, and constantly receive and escalate feedback from study sites and patients to the sponsor’s study team. This unique placement allows us to have the most complete, accurate, and up-to-date information regarding the recruitment process, which we relay back to our partners during weekly meetings.
For example, we may receive feedback from several patients that they are not happy with a particular study site. We are able to collect and analyse this data, and share what we find back to our partners. In another scenario, if a number of sites are burdened by similar logistical issues, our team is able to group the feedback together for resolution by the sponsor.
In addition, our partners are provided with access to an online dashboard where they can see all relevant metrics regarding our progress with recruiting patients throughout the duration of the study.
This blend of high-touch support for patients and study site teams, dedicated project management for sponsors, and real-time data reporting provide Clara partners a command center for their recruitment operations.
4. Do You Specialize In Optimizing The Study Design For Recruitment, Or In Rescue Support?
Depending on if you are looking for patient recruitment help in the beginning of the trial, or if you are having a difficult time with recruitment later on, it makes a difference which patient recruitment agency is best to contract for your trial.
Some vendors specialize in optimizing study design for patient recruitment, which would involve more early stage consulting on protocol design. Other vendors are more experienced with rescue support and have the resources and infrastructure to recruit patients in a tight timeframe when sponsors aren’t able to meet their recruitment timelines on their own.
We advise you to ask the recruitment agency under consideration what kind of experience and success stories they can share with you for the specific type of help that you require.
Clara Health: For each of our clients, we assign a unique study team that is able to support them in both early and late stages of recruitment.
A significant benefit of working with us from the beginning of the design process, is that we are able to play a centralized role and offload a lot of work from your study sites and your internal sponsor team, by consolidating a lot of the patient-facing activities through one central resource.
Let’s say you would like to use us, but already have a travel vendor for your trial. We are able to coordinate with the travel vendor to make sure that the patient never sees an interruption throughout their trial experience. Our unique position right in the middle of the communications between your external vendors, the study sites and your team allows us to make sure that the patients have a seamless, and fully integrated experience.
In another scenario, your study sites may have a list of potential patients, but may not have the resources to adequately screen the patients. In this case, they can send these lists to be processed by our patient support team, which will increase the speed and quality of recruitment, as well as improve the patient experience.
5. What Kind Of Pricing Model Do You Have To Offer?
Some vendors will offer a variety of pricing models so you can find the one that suits your trial and recruitment expectations. When considering which pricing model is right for your trial, you must analyze how flexible and well aligned the proposed pricing model is when it comes to all the possible recruitment scenarios.
Some patient recruitment agencies will bill their clients based on marketing expenses; for example, charging a commission on top of advertising costs. This budget model can be ineffective, because it rewards higher advertising spends, without necessarily holding the marketing team accountable for the quality or the results of their efforts.
Another budget model to be skeptical of is when a vendor proposes a budget structure that seems to align your team’s interests with theirs, but in fact still rewards subpar performance. This can happen when the proposal includes success fees to be collected upon hitting irrelevant or low-predictability metrics, such as impressions or clicks. This model incentivizes the vendor to send a large volume of traffic and doesn’t make an emphasis on the quality of that traffic.
In either of the above cases, the high volume of low-quality patient interest and traffic leads to study sites being inundated with more applicants than they can realistically handle and significant slowdown of patient processing times. In many cases, our team has heard from study site teams that they simply began to ignore referrals made by specific recruitment vendors, because the traffic was of such low relevance that they could not justify staying on top of every lead.
In more favorable models, vendors may blend the advertising spend commission model with billing on conversion points (such as completed screeners or completed phone calls with patients). This model is aligned better with a sponsor’s interests of enrolling patients, as vendors receive compensation on a variable basis that is conditional to success driven for the study’s overall recruitment effort. Bonus points here if the recruitment team makes certain to only refer the most qualified patient applicants to study sites.
ClaraHealth: We typically charge our partners a one-time setup fee to cover the logistics of onboarding our team, setting up our infrastructure, and working with sponsor teams to draft patient-facing materials for upcoming IRB submissions. The bulk of our compensation is earned on success metrics, such as completed phone screens, EMR screens, or final enrollment. This model was specifically designed to ensure that there is maximum alignment down the recruitment funnel between our financial interests and your interests of helping you recruit patients.
This model also allows for flexibility. By moving our success fees between major success metrics to weight our incentives at different points in the recruitment funnel, our team is able to arrive at budgets that make sense for our partners and for our business.
6. Do You Have An In-House Marketing Team?
This is an important question to ask, because you want to make sure that the vendor is not going to outsource advertising to a third party.
Marketing and advertising are core aspects of patient recruitment, and it is not a good sign if the patient recruitment agency is outsourcing this critical work. The organization should have proprietary information about what is effective and ineffective for recruitment. They should ideally also have in-house creative capabilities, patient advocacy relationships, and technology that can bring to life even the most complicated strategies.
And beyond a stellar understanding and experience of marketing clinical trials to patients, these teams should have a legacy understanding of how to work with stringent and difficult IRB review processes and internal reviews. They should be able to take input from the patient community, pair the feedback with robust datasets, and leverage the information to create marketing materials that engage potential applicants while also optimizing for a speedy approval by the IRB and other regulatory teams.
The right vendor should also have the capability to help you in pushing these recruitment materials to finish the line internally within your organizational structure. They should be able to speak to the why’s behind their strategy, justify the need for certain marketing materials, and augment your voice with marketing expertise.
This requires someone that can bring in a multitude of capabilities within one team, to help you throughout the entire process while also being accessible to you for direct communication, feedback and/or collaboration.
Clara Health: At Clara Health, all of our recruitment efforts are powered by a highly experienced in-house marketing team that knows the ins and outs of clinical trial recruitment. With a combined advertising experience of over 35 years, our marketing team is skilled in digital omni-channel clinical trial recruitment, while our patient advocacy team supports the grassroots and community level patient recruitment.
Depending on your particular trial’s patient community, our marketing team crafts a unique digital and offline strategy that leverages the best advertising channels via paid advertising and search engine optimization for ultra-targeted content pieces.
By combining our patient-focused internal infrastructure and expertise in digital and offline patient recruitment, we are able to reach your desired patient population in the right place, at the right time, and with the correct messaging and patient-first branding that allows us to actualize the enrollment potential for your study.
Through our internal compliance processes, and our team’s in-depth understanding of IRB requirements, we are able to ensure that the marketing materials designed for your study pass the IRB review process without compromising on their effectiveness for recruiting patients.
We are constantly building our own database of proprietary data that give us a real understanding of recruitment difficulty across various therapeutic areas.
If you would like to get a better understanding of the expected recruitment difficulty for your clinical trial, we offer a Free Recruitment Difficulty Assessment based on our proprietary data in your therapeutic area.
7. Have You Worked With Our Therapeutic Area In The Past?
It is helpful for a patient recruitment partner to have worked with your exact condition in the past, as the vendor will already have the data and experience to understand all the potential problem areas for recruitment.
It is also helpful if the vendor you are considering has done patient recruitment for a similar patient population, or for conditions with similar rarity. For example, if you are looking for help in recruiting for a Parkinson’s clinical trial, it’s a good indication if the vendor has recruited for a condition like ALS, as it would mean they have experience dealing with a neurodegenerative disease that is also a rare disease.
If the vendor doesn’t have experience in your therapeutic area, it is important to ask what processes they have in place to accurately determine the recruitment expectations prior to launching their campaigns and efforts. The right vendor will be able to accurately predict the potential pitfalls for recruitment in any therapeutic area regardless of previous experience, as well as ground the expectations for the recruitment difficulty levels through a combination of general expertise and their variety tools for testing your target patient population.
ClaraHealth: We are constantly running tests and building our proprietary data across various therapeutic areas. This data allows us to have an in-depth understanding and expectations of how difficult it is to recruit for specific patient populations, as well as which particular segment of the patient population is likely to enroll in a particular study.
8. Do You Have Recruitment Experience For International Trials?
If you are running an international trial, you would want to know if the recruitment agency has experience in running international trials and if they are compliant for handling patient data in accordance with the data privacy policies across different regions.
This question is geared less towards the vendor’s ability to recruit in a different language, but more specifically to their understanding of different laws and regulations in the regions you will be doing recruitment. The difference in language is not typically a major area of concern, as most vendors will have processes in place to be able to professionally translate any marketing assets in a way that will resonate with the specific international regions.
ClaraHealth: We have previously provided patient recruitment services for studies in the EU, Canada, UK, Australia, and South America.
ClaraHealth is fully compliant to run international trials everywhere in the world, outside of China and Russia.
9. What Happens To Patients That Aren’t Eligible For This Study, But May Be Eligible For Another One In Our Portfolio?
If you are running more than one trial within the same condition field that requires a similar patient population, your vendor may be willing and able to refer patients that don’t qualify to your other studies. The details of how this will be done, and whether or not you will incur an additional fee for referrals to other trials in your portfolio will be individual to every vendor.
The right recruitment vendor for your studies should have the flexibility within their financial structure and their company infrastructure to accommodate this request, should you happen to be in a situation where you are running several trials within the same disease sphere at the same time.
ClaraHealth: For sponsors running multiple trials within the same indication, our platform can automatically match patients to different trials via our patient support team to create a seamless experience for the patient and assist you with your global recruitment goals.
More commonly, we face the scenario where sponsors are running a single trial, and strive to deliver the exceptional patient experience that the applicants deserve. For patients who do not meet the qualifications criteria for our partner trial listings, our patient support team continues to assist them in finding another trial that fits them - whether that be in the form of being provided a list of alternative trials, or providing wraparound support to find the trial they need.
This practice is excellent for both patients and sponsors, as it allows patients to have an amazing overall experience with the sponsors that we represent. Oftentimes, these patients go back to their unique patient communities and share their experience of receiving help all the way through rather than being dropped all of a sudden upon not meeting the qualifying criteria. This ensures that the sponsors we help are perceived well in the community, and helps to improve their brand perception.
10. How Quickly Can You Create Recruitment Materials And A Winning Strategy?
When getting ready to set your clinical trial to launch, timelines can be quite demanding and every single day counts significantly. Each day that the trial is delayed to start can cost sponsors several hundred thousand (and in some cases, over one million) dollars in operational expenses and potential losses from delays in the commercialization of their investigational drug, so time becomes a very valuable and finite resource. In other cases, sponsors may be falling behind their recruitment timelines, and rescue support must be dispatched as soon as possible.
For these reasons, the ideal patient recruitment will be one that does not delay you in any timelines. Your recruitment vendor should have maximum flexibility with how quickly they are able to develop their materials and recruitment strategy.
The last situation you would want to be in as a sponsor with your recruitment vendor is to be told that they need an ‘x’ number of additional weeks to get it done. Helping you to meet these tight timelines should be one of the most important priorities for the recruitment vendor, and they should have the infrastructure and capacity to operate in a way that allows them to get things up and running as quickly as your situation requires.
Clara Health: For us, our timelines are typically most constrained by how long the IRB review process is going to be. Previously we’ve been able to turn over materials for submissions for a full trial recruitment campaign in as little as 48 hours.
We are typically able to match any timeline, and have the internal capability to go at the pace that helps to achieve the timeline goals and objectives of our partners.
11. What Will Be The Screening Process For Patients?
One of the most important determinants of the level of success for a study recruitment campaign is the screening flow for potential trial participants. The ideal recruitment partner will be able to create a frictionless screening experience for patients that robustly qualifies the patients while aiming to maximize the rates of screener completion.
This implies that the partner has the ability to thoroughly analyze the target patient population, and understand what screening process will be suited best for helping to qualify patients and form it into an accessible, pleasant and easy experience.
Screening flow design is a common pitfall that can make or break your ability to meet your recruitment goals, and therefore you want to be certain that the potential recruitment partner is a complete expert in designing high-converting and easy-to-complete screening flows. The ideal design breaks up the flow into manageable slices; for example, an initial digital screener may ask simpler qualification questions and be followed by a more robust phone screener.
In the case of poorly designed screening flows, patients typically come face-to-face with a form that attempts to take them through the entire qualification process in one large step. The consequences of a screening design that is completely stripped of human touch, is that patients often end up abandoning the application forms mid-way or lose motivation to take next steps, even if they complete the initial applications. By attempting to do too much at once, a sponsor can incur otherwise avoidable expenses, while losing potential enrollees along the way.
Clara Health: When it comes to designing the screening flow for our partners, we begin by doing a thorough research into the target patient population. After understanding exactly who and which communities we are going to be working with, we typically fragment the screening process into a digital screener and a phone screener.
Within the digital screener stage, patients are asked broader and less personal questions to ensure that they will be mostly qualified while also keeping the screener form as short as possible to optimize for full completion. In the phone screening stage, more specific and personal qualification questions are asked.
For very complex conditions, our platform is also able to consolidate EMRs for applicants and screen against details within those records.
This three-step screening process allows us to robustly qualify the patients, while also creating a patient experience that is more manageable, supportive, and motivating than confronting applicants with a convoluted and challenging screener.
Our patient support team welcomes and makes applicants feel comfortable and well taken care of, and in turn this increases the likeliness of them sharing more specific information. In addition, our patient support team is able to hear and respond to real-time feedback, and create a high-quality and truly personal experience based on the individualities of every applicant that goes through this stage.
12. How Did You Respond To Unpredictable Recruitment Challenges In The Past?
It is impossible to be able to fully predict how the recruitment process for a clinical study will unfold with complete certainty prior to beginning the campaign. There are always factors that will either be left unaccounted for, or will show up in the form of unpredictable situations. The processes that go into patient recruitment are complex and vary according to the individuality of the target patient population for the clinical study, as well as based on the study design itself, which also varies from study to study.
Given this individuality of each study, and the uniqueness of corresponding approaches for recruitment, it is important to understand exactly how the potential recruitment partner has handled challenges as they came up in the past. The goal of this analysis is to understand how efficiently the recruitment is able to adapt to unpredictable situations within recruitment, as well as to understand what their financial implications are when working with a particular partner.
Some questions to help you understand how challenges are handled by a potential recruitment partner include:
- Can you recall a situation when the initial recruitment strategy was not working? What was exactly done and how did your teams work to bring recruitment back on track?
- What are the fees, if any, associated with augmenting recruitment efforts in case they show to be ineffective?
- How long would it take to create new recruitment materials and submit them for an IRB review?
- Have there been any situations where you were unable to steer in the right direction because the initial recruitment framework was too rigid?
What you're looking for in a recruitment partner is somebody that is able to give you a consultative perspective and proactively provide guidance to steer recruitment to success. When working with a partner that is proactive, expect their general attitude and approach to problem solving to be along the lines of “strategies A and C aren’t working, we’ve gone ahead and submitted new materials for IRB review”.
A reactive partner that only creates changes under your pressure will slow you down and neglect core issues that you may simply not be able to respond to on time. Therefore, it is important that you find somebody that is able to respond to issues right away and keep you in the loop while doing so.
Clara Health: Our recruitment service teams (clinical operations, patient support, patient advocacy and marketing) monitor the recruitment situation for all studies 24/7. This gives us the unique ability to quickly address any issues that may arise, and if needed, to connect with our sponsors to provide consultative feedback and let them know our next steps.
Given our unique position right in the middle of patients, sites, and internal sponsor teams, we are able to constantly gather valuable information, which helps us to predict with more accuracy what potential issues may come up later in the recruitment process and address them before they become significant or can affect results.
13. Do You Support Both Patient Recruitment And Patient Retention?
Some companies may specialize only in patient recruitment, or only in patient retention. If you require both services for your trial it's highly recommended to find a vendor that is able to perform both of these services. There are clear advantages to this consolidated model that reflect both in the patient experience and in your overall costs.
Firstly there is higher operational efficiency when a vendor is able to support both services, as the same service teams will typically handle patients for either recruitment or retention. This means that certain resources within the vendor company are set up simultaneously to perform both services, which makes it cheaper compared to hiring another retention vendor that would have to set up entirely new frameworks to do their work.
However the larger advantages are seen in the seamlessness of the patient experience, as you're able to have a single centralized support team that sticks by the patient's side all throughout their participation in the trial. This bridges many communication gaps between you and study volunteers that are a result of a recruitment vendor handing off patients to a retention vendor.
Another advantage of having a single vendor to support both services is having someone with the ability to determine, measure, and report on key metrics for both services. This gives you the ability to unite all the measurements and have an overall, integrated understanding of exactly how your patients are enrolling and participating in your trial.
While it is possible to consolidate reporting from two vendors, this is an extra step that you may be able to avoid by finding a partner that will perform both services for you and provide reporting that takes into account the entire recruitment picture.
Clara Health: Our patient recruitment and retention models are centred around a seamless patient experience, with our patient support team at the heart of the entire process.
At some point a patient touches base with our support team that guides and fully assists the patient to set up visits, logistics, reimbursement, or anything else that is required for the patient to be able to comfortably participate. We remove all obstacles within our control that otherwise would have prevented someone from participating in the study.
Our centralized patient support also allows us to build trust with the patient community on behalf of your brand. Patients sense that they are treated with care and that the same team that helped them enrolled in the trial will also help them to participate in that as well.
We have a deep understanding of the entire patient journey when contracted for studies for both recruitment and retention services, and are able to get clear metrics on how the entire enrollment process is unfolding, which allows us to identify challenges early through seeing more complete data.
14. How Is Recruitment Reporting Typically Handled?
The type of reporting, the cadence at which you receive it, and its inclusion of all the critical metrics can significantly impact your understanding of how your trial is progressing in recruitment, and with that your level of responsiveness for making important decisions. For this reason, we advise that you get a crystal clear understanding of the expectations for reporting. Most patient recruitment companies will provide reporting via an older approach (sending formal reports) or the modern approach (via live dashboard).
There are many advantages of dashboard reporting, and if your vendor is able to support it, it’s highly encouraged that you request this format. Also often referred to as “on-demand reporting”, this reporting format allows you to see data that is updated as closely as possible to real-time. This means that instead of having delays of 3-4 days (or with some vendors up to 2 weeks), your data is continuously updated and you can access it at any time.
Dashboard reports also allow you the ability to interact with the data in front of you, by giving you the ability to compare specific date periods or relating the recruitment factors that you are most interested in seeing.
Some Foundational Reporting Metrics For Most Recruitment Processes Include:
- Impressions: the number of times that that advertisements for you campaign have been seen
- Unique Website Visitors: the number of people that have viewed the recruitment page for your study
- Completed Applications: the number of applicants that have completed the pre-screening application form
- Passed/Failed Applications: the number of applicants that have passed or failed the pre-screening application form
- Completed Phone Calls: the number of applicants that have made contact with patient support in for a screening/enrollment support call
- Passed/Failed Phone Calls: the number of applicants that have passed or failed the screening call
ClaraHealth: We provide all of our clients with access to a dashboard that is updated as closely as possible to real-time. This dashboard is accessible 24/7 and is a tool for speedy insights, as well as keeping our clients aware of the entire recruitment process without needing to request anything from us.
15. What Is Your Relationship With Patients?
It is important to know how patient-oriented the potential recruitment vendor is, because it is a significant determinant of their ability to succeed in helping you with patient enrollment.
A recruitment vendor with close and authentic relationships to the patient community typically has a deep understanding of how to best serve these patients to create an amazing recruitment experience. In addition, vendors that work alongside patients are able to create more engaging and comprehensible recruitment materials, as they are able to receive vital feedback regarding the recruitment language and creatives to be used in recruitment campaigns. It also allows the vendor to consult real patients to accurately target the demographic after determining the ideal patient personas based on received feedback.
Another significant benefit of having a strong relationship with patient communities in a vendor is that it allows you to tap into their patient advocacy networks to spread the word about your clinical trial, opening up an additional ultra-targeted recruitment channel.
Patient recruitment vendors that have weak relationships with patient communities simply do not have access to these benefits, which are so helpful for recruitment in trials for broad conditions, and a complete necessity for rare disease trials.
Clara Health: We have a dedicated patient advocacy team that has been with us since the very beginning. Patient-focus is a core part of our DNA, and we’ve built the entire company and recruitment infrastructure around creating the ideal experience for patients. Our products, platform, services, and teams all work in the service of the patient.
Additionally, we’ve spent years building patient community relationships across many different therapeutic areas, which allows us to get genuine and authentic feedback around marketing materials, our recruitment strategy, and service offerings we build out for specific trials.
We also have the capability to build partnerships in an authentic way, such that we can reach into patient communities on behalf of a pharmaceutical company, giving our partners the opportunity to start a conversation with patients through our patient advocacy team in a trusted fashion.
16. How Do You Recruit A Diverse Patient Population?
Over the last couple of decades the FDA has made a focus on promoting recruitment practises for clinical trials that would lead to the best reflection of the population that would most likely use the medication. It is important that the recruitment vendor has a thorough understanding and a marketing strategy in place that would reflect diverse patient recruitment practises, as this is both a best practice and a risk factor that could potentially prolong the treatment from coming to the market, or getting FDA approval altogether.
What often happens during Phase 1 and Phase 2 of clinical testing, is that the inclusion and exclusion criteria is structured in a way that would increase the sponsoring company’s confidence in seeing the results they would like to see in the lab. However this practice skews the data set, as the treatment gives good results in only one type of the patient population group, while under-representing another group.
It is important to test the treatments on a diverse population to avoid harming other untested populations in the future. And, the less representation there is of all the groups that would be using the treatment, the less likely it is that this treatment would work for the patients that would actually be using it.
As a sponsor, you are typically bound to the study sites for the majority of your recruitment traffic. This is a significant challenge, because sites may not have lists that would be inclusive of the patient population that should be represented in your clinical research.
Your recruitment vendor should be able to help you by leveraging their platform infrastructure, access to digital/traditional/patient community channels, as well as recruitment experience to help you in recruiting a patient population that most accurately represents patients that would be using treatment after it is approved by the FDA.
Clara Health: With our omni-channel marketing approach, we are able to tap into diverse pockets of traffic to reach specific patient populations. We do this by building a patient diversification recruitment strategy that allows us to reach patients representative of specific groups, by utilizing a mix of digital recruitment combined with patient advocacy outreach.
In addition, we are also able to generate new partnerships with specific patient communities that increase our effectiveness in diverse recruitment.
17. How Do You Recruit Patients?
One of the reasons to ask this question is that it gives you insight into what recruitment capabilities you don’t yet have so that you can layer the additional outreach efforts of the recruitment partner along the strategy you already have in place.
Finding a partner that specializes in recruitment channels that you do not have access to, or expertise in, allows you to maximize your coverage and make sure that patients are able to learn about your trial wherever they are.
Understanding of how your vendor is planning to recruit patients for your study will also show the level of diversification within the recruitment strategy. A more diversified recruitment strategy helps you to reduce your risks, as you are able to experiment with different recruitment channels and have more room to scale your recruitment efforts if needed.
For example, if you are planning on only using study site lists for recruitment, this strategy may yield results in the short-term, but would potentially be difficult to scale. Once the list of patients becomes exhausted, recruitment may stagnate and you risk falling behind your timelines and recruitment goals. On the contrary, if you are also working with a vendor that is doing digital, offline, and grassroots recruitment, you’ll have additional sources of study traffic that will continue bringing in patients despite exhausting study lists.
Clara Health: When designing a recruitment strategy for our clients, we start by conducting extensive research into the target patient population to understand exactly which recruitment channels will work best, as well as what kind of marketing materials are needed to maximize results. We do this by consulting with our internal patient advocacy and support teams, our clients, patients, and tying it back with any existing proprietary data we have on the therapeutic area and the target patient population.
We have the presence and access that makes it possible for us to tap into any of the three patient traffic sources: digitally, via offline advertisement, or through engaging with the patient community.
After the campaign goes live, we constantly monitor and optimize our performance to ensure that our efforts are efficient, and result-oriented. We also have the flexibility to tie in any traditional recruitment advertisements (such as billboards or radio ads) if requested by our clients.
18. Do You Offer Any Additional Screening Services?
One of the most important qualities of the ideal recruitment partner is their ability to have a robust qualification process while screening potential study volunteers.
There are several issues that can be detrimental to your recruitment success when under-qualified patients are referred to study sites. The most visible and impactful problem with referring unqualified patients is that processing times by the sites can significantly slow down, especially if unqualified patients are referred in large volumes.
For this reason it is important that the vendor has the necessary infrastructure, platform, tools and teams to create a custom, efficient, patient-friendly, and highly-converting screening experience that will help you to excel in all the facets of recruitment that maximize your enrolment results.
Clara Health: We work directly with sponsors to create a seamless patient screening experience that is easy to go through, and maximizes the number of qualified patients referred to sites. After thoroughly analyzing the study protocol, screening criteria, and the target patient population we divide the screening process into several stages to make it as easy as possible for a potential patient to apply. We have a large variety of screening tools and experience that allow us to build cutting-edge recruitment processes that will most likely perform, and do this in a consultative and collaborative nature with you to ensure all of your needs for your study are being met.
We often work with qualification criteria that apply to a very narrow segment of the patient population with the condition in question. Segmenting the screening process into several stages allows us to be very efficient, create a positive experience for patients, maximize screener completion rates, and fully qualify patients prior to referring them to study sites.
19. What Marketing Materials Can You Produce?
Depending on whether the recruitment vendor produces marketing materials in-house, or outsources the creative work to an outside agency will make a difference to the operational efficiency of your partnership and the overall quality of your experience. It is important to find out what kind of assets the vendor has the ability to create, and what the capacity is for customization.
For example, if you wish to produce a professional video for your digital campaigns, the vendor may or may be able to do that for you in-house, which would have a significant impact on the timelines of the deliverable. For these reasons, we advise that you find out exactly what kind of assets the recruitment agency will be able to create in house (and how many days this typically requires) as well as which type of marketing assets would require outsourcing to another agency and what the potential timeline delays would be associated with that.
Clara Health: We have the in-house capacity to produce imagery, videos, ad copy, and custom creatives based on the specific needs of our clients. All marketing assets are a collaboration between our in-house marketing team and patient advocacy group that allow us to create highly engaging materials that truly speak to the target patient population.
20. What Are Your Key Specialties In Patient Recruitment?
This question will help you understand exactly what kind of company you are dealing with and what their capabilities are when it comes to recruiting patients. There are many organizations that help with patient recruitment in addition to other services, but it is not their key specialty. Contracting with agencies that do patient recruitment as add-on service may put you at risk of working with someone that is not a leader in this particular service, and may lead to consequences for your recruitment success.
If you are looking for a vendor to take full charge of patient recruitment for your trial, it is recommended to work with an agency that has a primary focus and specialty in this particular service.
Furthermore, understanding the key specialties of the vendor allows you to clearly see if their offering and capabilities can bridge the gap with your current recruitment strategy.
Clara Health: At ClaraHealth, our specialty is tech-enabled patient centric recruitment.
We augment your recruitment efforts with our end-to-end digital technology based recruitment strategy. We are able to build on top of what you already have and with the help of digital recruitment, our Clara platform and patient-focused care ensure that you are reaching patients everywhere they are while having a stellar recruitment experience.
21. Can You Share Enrollment and Patient Funnel Metrics From Previous Trials?
You may want to ask the potential recruitment partner to share previous successes and performance metrics from past trials. While recruiting teams vary in what kind of information they are allowed and willing to share, this is a good practice for determining their abilities to recruit patients.
It is important to keep in mind that the most helpful examples to gauge a potential recruitment partner’s performance will be from studies within or as close to your therapeutic area as possible. The recruitment difficulty and standard as to what is considered to be “good” recruitment performance depends on the individual study itself.
There’s a multitude of factors that affect the recruitment performance, some of which include the therapeutic area, target patient population, site efficiency, and protocol design. When analyzing data from past trials, it is important to gauge the final results against all of these factors to determine with highest accuracy if the recruitment agency helping was truly successful.
ClaraHealth: We will happily share funnel information showcasing our recruitment capabilities and performance in past trials.
If you would like to request enrollment and funnel metrics, get in touch with us and we’d be happy to provide you with most useful information as it relates to your current or upcoming clinical trial.
22. Do You Offer Site Follow-Up Services?
Some recruitment teams will make a referral to the site, and not provide support to patients or sites beyond that point. It is important to ask if the recruitment vendor is able to offer site follow-up services in addition to referring patients, as having patient and site support will help you to minimize drop-offs in these later stages in the recruitment funnel.
One of the common issues that are encountered during the recruitment process is that after patients are referred to the site, they are not hearing back, or it is taking too long for sites to respond to their application.
Having a team to check back in and constantly monitor that all applicants are being contacted in a timely manner is crucial, and will allow you and your recruitment partner to take necessary action before this begins delaying your recruitment timeline.
Clara Health: We have a dedicated site support team that works with every site for your trial in a customized way. Our patient support team is in continuous communication with the sites which gives us a unique ability to manage the patient handoff in a way that is inline with the processing capabilities of each site.
We maintain contact with the patient throughout the entire process, making sure that they are hearing back from sites and are being helped, and are always on standby to offer additional support to sites when they are becoming slow and overwhelmed.