FDA Guidance on Clinical Trials During COVID-19 Pandemic

Much attention has been paid to the impact of the COVID-19 pandemic on the supply chain for medicines we rely on, but there has been less focus on the impact of medicines yet to come. The advancements in cancer care alone during the past few years have been breathtaking. The medicines pipeline is the focus of many who need and hope for a new treatment for a life-threatening condition.

This week FDA issued a new guidance document entitled “FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic“. This would seem to set a record for the development of any guidance document from FDA, some of which take years to cultivate through the draft stage. In it, FDA concisely enumerates some of the many obstacles to conducting a clinical trial in our current circumstances – quarantines, travel restrictions, sites that are under lockdown, supply chain of the investigational compound to name a few.

There has already been a lot written about it providing explanation already and there is no point in recreating the wheel and here is among the best courtesy of the Regulatory Affairs Professional Society. But briefly, FDA encourages sponsors to consult with Institutional Review Boards (IRBs) very closely and sanctions also the deviation from protocols of the trial may be initiated unilaterally in order to protect health and well-being of study subjects. It is a worthy goal, to be sure, but where there are such adjustments made by study sponsors, one can imagine that it will later ultimately complicate the assessment of the trial when it comes to the approval process.

FDA also stated that sponsors should be prepared to assess patients for safety from a distance given the potential of travel restrictions. This most certainly means the use of the telephone, but makes the case – as the pandemic does across many areas – for creativity when it comes to exploring virtual means for exchanging information. That goes from telemedicine, to the release of data at virtual medical meetings.

Much of the document is geared to considering the impact of the pandemic on the role of study participants. But there are also likely to be issues where those who are involved in conducting the trial itself – the investigators – are also negatively affected, impacting the collection of data.

In short, FDA has injected more fluidity to respond to circumstances into the process. While important, it is not likely enough to overcome absolutely all the obstacles to conducting clinical trials in this environment. And once this is over, there will be more complications as these trials are assessed for approval and as the gold standard for consideration of new medicines is preserved during this difficult time.

Photo by Louis Reed on Unsplash

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