FDA Expects the Pandemic to Create Opportunity to Improve Cancer Trials
(Thursday, October 15, 2020]​
The pandemic has created unprecedented disruption in all cancer clinical trials but has also forced the sponsors to explore alternate ways to conduct their trials which could have long term positive effects on such trials much after the pandemic, opine FDA’s top experts in an article in the Journal of American Medical Association. The pandemic has led to sharp decrease in patient enrollment and continuation. To counter that sponsors have tried to amend the protocols to include remote patient health monitoring, sending study drugs to patient’s homes, and using revising endpoints amenable to remote monitoring. Since some endpoints such as tumor scans or biomarker levels in blood cannot be collected in virtual visits, sponsors are allowed to arrange alternative locations for data collection with IRB approval for the amended protocol procedures. The authors contend that some of these pandemic-induced changes could improve future cancer trials in two ways. First, the conduct of trials outside of traditional trial settings and in different populations could help generate new insights into patient experiences and explore new endpoints more relevant to the real world patient experiences. Second, use of virtual clinical trial operations could increase patient access allowing remote enrollment of more diverse patient populations, particularly in minority populations. These changes in trial operations were always desired; the pandemic has provided the right incentive to expedite their implementation.