Impact of SARS-CoV-2 & COVID-19 on Volunteer Interest in Clinical Trial Participation
The COVID-19 pandemic has had a global impact on nearly every facet of life. Aside from the immediate health emergency and burden to society, SARS-CoV-2, and the resulting coronavirus disease (COVID-19), has directly affected nearly all social, economic and political conventions worldwide. The conduct of clinical research and, by extension, the continuity of drug development has not been immune to the effects of COVID-19. According to a survey published by CenterWatch, 69 percent of responding investigative sites indicated that lockdown measures have impacted their ability to conduct ongoing trials and 78 percent said COVID-19 affected their ability to start new trials.
In response to the pandemicís impact on clinical trial continuity, the Food and Drug Administration (FDA) acted swiftly with the publication of new guidelines and strategies on how sponsors and investigative sites could adapt to the pandemic while also emphasizing patient safety and trial integrity. While a wealth of information exists on adapting these guidelines into practice, one critical element to the maintenance of clinical trials during the COVID-19 pandemic that has not been adequately addressed is the impact on volunteer interest and motivation to participate in a clinical research trial during a global pandemic.
Given the fragility and uncertainty of clinical trials in the era of COVID-19, many companies have decided to pause or delay activity in multiple different development programs. The long-term impact of delayed new drug approvals will be significant and unavoidable. As resources shift toward new drug therapies for COVID-19 and away from other life-threatening diseases, opportunities for advanced treatment and cures become more obscure. Delays in initiating early Phase 1, first-in-man, safety and tolerability pharmacokinetic (PK) studies, as well as PK studies in special populations with hepatic and renal failure, contribute to the global impact of delayed new drug development. In concert with augmented safety polices, another critical factor that must be considered in maintaining ongoing clinical research continuity is the volunteerís potential hesitation regarding COVID-19 risk, layered with the inherent risks associated with clinical trial study participation.