Advancing Clinical Trial Protocol Development While Social Distancing

The COVID-19 pandemic has torn across the globe, necessitating drastic changes in every corner of society. As we are all asked to limit our contact with the world outside in ever-increasing intensity, many are left grappling with the difficulty of moving the large majority of the workforce to remote work entirely. The scientific world is no exception from this, with researchers and clinicians exploring new ways to carry on critical work needed to support the development of life-altering treatments that patients desperately need.

It all begins with the development of the clinical trial protocol. The FDA has increasingly called for more patient input and data, both with the 21st Century Cures Act and Draft Guidance on Patient-Focused Drug Development. This focus on patient voice has become widely regarded as an important, positive evolution in executing successful clinical trials, and these new regulations have medical study teams across the globe seeking new ways of gaining patient insight. With people around the world entering quarantine and practicing social distancing to limit the spread of COVID-19, it might seem that engaging with patients and caretakers is harder than ever. However, recent developments in crowdsourcing platforms combined with the use of powerful software tools, such as the Transparency Protocol Builder, have not only provided access to patients, but offer a revolutionized way of allowing physicians, patients, and researchers to interact during the development of a clinical trial.

Crowdsourcing platforms leverage a qualified global cohort of patients and healthcare professionals specific to the disease of interest. Participants can answer questions and provide feedback to protocol drafts, drastically cutting down on costly protocol amendments. This is even more critical in light of the restrictions brought on by COVID-19, providing protocol developers unparalleled access to patient and caretaker input in the drafting process without breaking isolation. Additionally, by receiving input early in the process, participants may present novel concepts and ideas produced by their individual experiences and can help identify and prevent unsound or care-prohibitive methods from reaching approval.

Approaching clinical trial development from a global perspective also has the potential to be beneficial to patient recruitment. By providing unprecedented access to target patients irrespective of their location, patients can remotely apply for trials, providing avenues for clinical trials to proceed without in-person interactions. If necessary, patients may then be screened further by telemedicine or home-visits, a transition that is recommended given the spread of COVID-19. Thus, access to applicable patient cohorts is increased, while still maintaining appropriate social distancing implemented to flatten the curve of infection.

Some may be skeptical that these methods are new and untested, but in fact the reverse is true. In 2012, the first protocol developed using crowdsourcing resulted in the clearance of an investigational new drug application by the FDA. Another study, M-RePoRT (Metformin for Rising PSA Remote Trial) was designed with input from a group of over 70 physicians and patients and demonstrated the feasibility of telemedicine-enabled study visits – as opposed to onsite visits. Furthermore, an abundance of benefits was highlighted by a study on the power of crowdsourcing in health-related studies including the potential for large-scale cohorts and speed in the drug discovery process.  These are just some examples showcasing that the addition of powerful technology and crowdsourcing platforms into the new remote workflow has the potential to boost productivity, reduce costs, and protect researchers and patients.

Ultimately, COVID-19 has placed clinical researchers and patients around the world in a difficult position. However, crowdsourcing platforms and powerful technology successfully meet many of the needs of protocol developers and trial administrators while greatly reducing the exposure of researchers, patients, and caregivers to the risks of COVID-19.