In response to the COVID-19–related public health emergency, clinical research regulatory authorities have recognized the potential challenges posed by COVID-19, including site closures, travel restrictions, quarantines, investigational product availability, and staff and patient infections. Such occurrences may hinder and complicate meeting protocol requirements, including treatment administration, clinic visits, laboratory tests, and imaging studies. In response to this unprecedented situation, the FDA issued guidance suggesting consideration of telephone or video visits, performance of laboratory tests and imaging studies at local sites near patients’ homes, delaying certain assessments, alternative sites for treatment administration, and remote monitoring. The NIH Central Institutional Review Board (CIRB) allowed for remote informed consent procedures and use of electronic signatures. The NCI Cancer Therapy Evaluation Program (CTEP) issued provisions for nonstudy local healthcare providers to perform study follow-up procedures, as well as shipment of oral study therapy directly to patients’ homes.
These COVID-19–related allowances represent one of the greatest shifts in clinical research practice in recent history. For decades, professional organizations and patient advocacy groups have called for greater flexibility in the design and conduct of cancer clinical trials, with the intent of increasing access to trials and decreasing demands on trial participants, thereby improving trial enrollment, completion, and result generalizability.1–3 Additionally, the FDA and other regulatory authorities have identified the importance of “real-world” data in the evaluation of new therapeutic entities.4–6 Despite these efforts, until COVID-19, cancer clinical trials continued to increase in complexity, with more numerous and stringent eligibility criteria, and greater numbers of screening and on-study procedures required to be performed in shorter time intervals.7,8
To determine the impact of COVID-19–related changes, and whether some changes could potentially be continued after the COVID-19 emergency ends, we performed a survey among clinical research professionals at an NCI-designated comprehensive cancer center. Given their detailed familiarity with protocol requirements and regular and close contact with patients, sponsors, investigators, and regulatory agencies,9,10 these individuals are uniquely and ideally positioned to provide key feedback on these considerations.
The authors wish to thank Ms. Dru Gray for assistance with manuscript preparation.
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