In a recent report into how the global COVID-19 pandemic is shifting the way clinical trials are for the foreseeable future, GlobalData (data research firm) has found that 67% of healthcare professionals that were surveyed this past summer, plan to utilize decentralized clinical trials 1.
The significant shift to decentralization (no physical sites & remote patient visits) and away from the traditional model for recruiting and conducting clinical trials (relying on physical sites & in-patient visits) is the natural response of the healthcare industry as whole to the unforeseen challenges caused by COVID-19.
According to BioPharmaDive, as of May 2020, nearly 100 companies have experienced disruption due to the Coronavirus 2, threatening to delay clinical trial research by years.
Not only is it very difficult to have a successful centralized clinical trial in 2020, the industry is moving away from this model out of both necessity and higher performance metrics.
In contrast to traditional clinical trials, decentralized clinical trials are “trials executed through telemedicine and mobile/local healthcare providers” as defined by the Clinical Trials Transformation Initiative 3.
For the same reasons that classrooms and work environments have become mostly or completely remote in the United States, COVID-19 is challenging researchers to transition away from the boundaries of an antiquated system and into a virtual, decentralized process that offers more protection to patients, and higher likelihood of increased trial adherence due to the nature of remote assessment.
In the PDF (FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency) released from the FDA focusing on logistical considerations for clinical trial conduct in the setting of COVID-19, including impact on clinical sites, clinical investigators, and trial participants, they outline the barriers researchers are dealing with now that COVID-19, going on to say...
“Since trial participants may not be able to come to the investigational site for protocol specified visits, sponsors should evaluate whether alternative methods for safety assessments (e.g., phone contact, virtual visit, alternative location for assessment, including local labs or imaging centers) could be implemented when necessary and feasible, and would be sufficient to assure the safety of trial participants.”
The key takeaway is that in the face of COVID-19, in-person, centralized trials will need to be modified to adapt to the current times and issues both researchers and patients face.
With so much money at stake and patients’ safety as a top priority, now more than ever decentralization is critical to the success of clinical trials.
How Can Decentralization Support Recruitment & Improve Logistics?
“Decentralization of clinical trials decreases the number of required on-site visits, as patients are given the power to make a record of their own vital signs and communication tools like phones or video calls allow researchers to find out exactly what is going on with each patient. “
With more than 80% of clinical trials failing to meet their designated patient enrollment deadlines pre-COVID, now more than ever the industry is forced to adapt to a larger threat, one that has the potential to disrupt the entire clinical trial industry.
Recruitment has always been a difficult challenge, and in today’s climate it’s substantially more difficult for those that choose to stay centralized.
The industry is shifting towards decentralization.
And very often, the lack of patients isn’t the only road block in patient recruitment. In many cases, the needed number of patients agree to enroll, but faced with the logistical challenges aren’t able to participate.
During a COVID-19 pandemic, recruiting patients for centralized clinical trial models is more difficult than before. Study sites are frequently shutting down and reopening (if possible), depending on the status of local health risks, and many patients are simply not willing to make that compromise of their safety.
It is absolutely critical that this reality is well understood prior to mapping out the study design and protocol.
Traditionally clinical trials are mostly performed in a few central locations, typically key urban areas.
Given the disproportionate effects of COVID-19 on densely populated urban areas, it is expected that non-COVID-19 clinical trials conducted in these locations may struggle with enrollment and patient monitoring.
Decentralization of clinical trials decreases the number of required on-site visits, as patients are given the power to make a record of their own vital signs and communication tools like phones or video calls allow researchers to find out exactly what is going on with each patient.
This greatly improves the patient satisfaction and participation rates, as this format removes one of the biggest obstacles to participating in clinical trials, which is travel, cost & inconvenience . In addition to this, decentralized clinical trial design is much more inclusive and allows sponsors to access patients that would not otherwise have the opportunity to travel - such as those living in rural areas, or patients that aren’t able to do long-distance travel.
The ultimate benefit of decentralized & virtual clinical trials is that it accelerates clinical trial timelines. It is more important than ever to design trials around the patients’ needs, because they are a key stakeholder of the entire process.
And as the majority of sponsors begin shifting from the traditional clinical study model and into decentralized clinical trials, it’s becoming especially critical to shift with the industry as well.
If you are not able to design a study around your patients’ lifestyles and the current global conditions, it will likely be significantly more expensive to conduct, as well as put you at a greater risk of not being able to fill the trial with dream patients.
In the midst of a global pandemic this means recognizing that centralized clinical trials are an uphill battle that will rarely be won for the foreseeable future, and taking the steps necessary to making the study as accessible as possible - which today implies going remote.
Are You Ready To Decentralize Your Study? Download Our Free Whitepaper!
At Clara Health, the core of our work is in assisting clinical trial sponsors in transitioning to the decentralized clinical trial model in the most efficient manner, through leveraging our expertise, technology and patient-centric approach.
Download our free whitepaper and learn how decentralization can lead to better recruitment and patient adherence, then see how it helped Amlyx increase trial acceleration by 200%.
1"67% of healthcare experts plan to use decentralized clinical ...." 1 Sep. 2020, https://www.globaldata.com/67-healthcare-experts-plan-use-decentralized-clinical-trials-near-future-due-covid-19-says-globaldata/.
2"A guide to clinical trials disrupted by the coronavirus pandemic." https://www.biopharmadive.com/news/coronavirus-clinical-trial-disruption-biotech-pharma/574609/.
3"Clinical Trials Transformation Initiative." https://www.ctti-clinicaltrials.org/.