Reinforcing Quality by Design in Clinical Trials

In a recent video interview with Applied Clinical Trials, Vera Pomerantseva, director of product management, RBQM, eClinical Solutions, discussed FDA's recent guidance on protocol deviations and its impact on clinical trial management. She highlighted the importance of quality by design (QbD) and critical to quality (CTQ) factors in reducing protocol deviations. Pomerantseva views this guidance as an official acknowledgment of existing practices and an opportunity for improvement.

ACT: How will FDA’s protocol deviations guidance affect the roles of quality by design and critical to quality factors?

Pomerantseva: I do not anticipate any significant impact on the existing roles and responsibilities. To me, themes are that it is consistent with the recommendations provided by TransCelerate, which were followed by many companies already, there's really no significant contradictions. Maybe for those who are behind in terms of the process maturity, there might be some impact, but again, to me it is in line with everything I saw so far, it's also in line with the recently adopted ICH E6(R3) revision. I would rather envision this guidance as an official acknowledgement of what already exists, and with the opportunity maybe to collectively improve and address some of the barriers which we still have. Actually, that is a perfect segue for me, or another important point. This guidance is still a draft and open for comments, I think, until February this year, so I would encourage all the industry peers to provide their feedback, share, and maybe challenge. I provided mine already. I think it's a great opportunity for us to address the challenges we have.