Was there a conflict of interest in conduct of the clinical trial that compromised ReGen’s data?
No. The Vail Valley Medical Center IRB, which oversees clinical studies at the Vail Valley Medical Center and is not affiliated with ReGen Biologics, received an FDA warning letter. One of the issues identified in the letter was the role played by a member of the IRB (which stands for Institutional Review Board) who had been a member of the Vail Valley IRB before the Menaflex clinical trials began. While this member’s primary business affiliation was with Steadman Hawkins Clinic and the Steadman Hawkins Research Foundation, he also served as the senior VP of Scientific Affairs for ReGen. However, this member’s continued presence on the review board did not create any irregularity in the IRB’s consideration of ReGen’s study because he did not participate in votes related to the ReGen study and only provided information to the IRB, as permitted by FDA’s IRB regulations. The IRB responded to the FDA, addressed the observations included in the agency’s letter, and implemented practices and
