18 May 2021 - The US FDA is not amenable to changing study outcome measures or sample sizes for gene therapy clinical trials but is encouraging sponsors to fill in gaps in data collection with telemedicine and remote visits.

Wilson Bryan, director of the FDA’s Office of Tissues and Advanced Therapies in FDA’s Center for Biologics Evaluation and Research, told a 12 May meeting of the American Society of Gene and Cell Therapy that the pandemic is prompting declining enrolment in gene therapy trials.

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