Wallace Quoted on the Effect of COVID-19 on Clinical Trials

Partner Joel Wallace shared his insight on the updated guidelines from the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) on running clinical trials and the potential effects of the COVID-19 pandemic on those trials.   

Joel said that while pharma-funded studies are not bound by the guidelines, many trials are conducted at research centers that have a mix of private and public spending. These centers would have to comply with the NIH guidelines for NIH-funded studies, and so may affect pharma-sponsored trials as well.

He added that when it comes to trial enrollment, since patients are not coming in for regular checkups, screening for trial participation will be affected as well.

Phase I safety studies that recruit healthy volunteers could particularly be held up, he said. Research organizations or divisions at hospitals that routinely recruit volunteers and run lab work are being told to pause operations to devote resources to COVID-19, which in addition to the increased difficulty in getting volunteers could hold up Phase I trials.

Enrollment hurdles aren’t the only effects the COVID-19 pandemic is having on clinical trials, with additional challenges including patient monitoring and overall testing. 

The FDA’s updated guidelines recommended evaluation of alternative patient monitoring methods such as phone or virtual visits. Shortly before the FDA released these guidelines, the Centers for Medicare and Medicaid Services expanded coverage for telehealth services.

However, Joel noted that this would only apply to clinical trial patients who are receiving a Medicare-covered drug during the trial.

Joel said that the lack of broad testing for COVID-19 is also a significant challenge since it is unknown how many patients in an ongoing study may be asymptomatic but positive for the virus. Without adequate testing, the population on a trial that is positive for COVID-19 cannot be separated out from the rest.

Moreover, COVID-19 testing is not part of trial protocols, which may complicate the study from a regulatory and data integrity point of view, he said, explaining that while trials are designed to consider messy data, the study size may not be enough to accommodate large numbers of sick patients.

He added that this would also affect standard assumptions made to design a study, like the mortality risk in a geriatric study.

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