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FDA Issues Contingency Guidance for Clinical Trials Affected by COVID-19

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CROs are also adapting to pandemic.

Numerous aspects of the COVID-19 pandemic could be disruptive to the success of clinical trials, and in new guidance, the FDA has acknowledged that deviations from trial protocols may be necessary.

In guidance that was issued specifically in response to the COVID-19 pandemic, the agency acknowledged that clinical trial protocol modifications may be made but also must be documented and reported as promptly as possible. The FDA notes that trial participants may be sickened by COVID-19, supplies of investigational drugs may be interrupted, and quarantines and closings may make on-site patient visits impossible.

Related: See full-text version of this post at The Center for Biosimilars

In the event that trial participants are unable to come to the investigational site for scheduled visits, phone contact and virtual visits are acceptable alternatives when feasible and necessary and patient safety will not be compromised. Alternative locations for treatment may also be considered, the FDA said in the guidance.

How disruptive pandemic and social distancing will be to clinical trial enrollment has yet to be seen. But contract research organizations (CROs) started to respond to the epidemic before it became an emergency in the U.S. last week, partly because many of the companies have sites around the world, including in China. During an earnings call in early March, PPD chair and CEO David Simmons said the company had an established a pandemic committee and was assessing the use of remote trial monitoring. In a letter on the company’s website that was accessed today, ICON CEO Steve Cutler says the company’s study teams are contacting enrollment sites regularly to determine the effect of the pandemic on study timelines and that monitoring visits are being changed on a study-by-study basis.

The FDA said investigators should keep patient safety at the top of their concerns. Further, they should make assessments and decisions that are in accord with the specific circumstances in each instance that may require a modification of study conduct. Those decisions may involve whether to continue use of the investigational product in patients who have been participating in the trial, continue trial recruitment, or change patient monitoring.

“In all cases it is critical that trial participants are kept informed of changes to the study and monitoring plans that could impact them,” the guidance says.

 

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