What’s New in GCP?

DMCs Are Not Being Overused, But Members Might Be

Reprinted from the Guide to Good Clinical Practice with permission of Thompson Publishing Group, 805 15th St., Washington, D.C. 20005; www.thompson.com. To learn more about the Guide to Good Clinical Practice, visit: www.firstclinical.com/gcpguide. Data Monitoring Committees (DMCs) are not being overused, but the increasing use of DMCs in clinical trials raises concerns about finding and training new DMC members, a Clinical Trials Transformation Initiative (CTTI) working group concluded. “This project started with a sense of an impending crisis in DMCs,” Jane Perlmutter, founder and president of the Gemini Group, told a briefing on the project at the recent Drug Information Association annual meeting. “On the one hand, there seems to be more and more of them, and on the other, the people called on to be members are getting older,” said Perlmutter, who is a member of the working group. “We tried to see if we are overusing DMCs or whether we are under-developing people or it could be a combination of both,” she said. “It is really necessary to be a little bit crisper about [the mission] but, given the increased complexity, the increased use of adaptive trials, and the increased interest in transparency, it is not clear to me that we are overusing them — we probably just need to be clearer. We need bright people for them and what we are going to focus on is what it is going to take to develop that.” “There has been some confusion about DMCs, and a lot of that has to do with terminology,” added Karim Callis, an FDA senior clinical analyst who is also a member of the working group. He noted the National Institutes of Health call such committees “Data Safety Monitoring Boards” and others call them safety committees, but said the working group found such committees deal with more than subject safety. “The evolving role of DMCs and the emergence of other committees with overlapping functions may lead to unclear expectations about what DMCs are doing,” Callis said. The definition that the working group developed for DMC is: an independent group of individuals who review the ongoing conduct of clinical trials to monitor efficacy and patient safety and to ensure the validity and integrity of the trial.