The FDA’s David Lepay, M.D., Ph.D., gave a lecture titled "Good Clinical Practice — Are we there yet?"
Photo by Dana Johnson
Strong systems key to trial safety: panel
It's not good enough for an academic medical center to conduct high-quality studies involving patients and healthy volunteers.
Systems must be in place to guarantee safety, to encourage the reporting of research misconduct including fraud, and to inform the public about the importance of participating in clinical trials.
Otherwise, it will be difficult to attract adequate numbers of research subjects for studies of promising new drugs and treatments, and further progress in medical care may lag.
That was the take-home message from a symposium on clinical trial regulations and good clinical practice held Tuesday at the Vanderbilt Student Life Center. The event was sponsored by the U.S. Food and Drug Administration and Vanderbilt University Medical Center's Office of Research.
“We have heard loud and clear the mandate from Congress, the NIH (National Institutes of Health) and the public,” said Jeffrey Balser, M.D., Ph.D., associate vice chancellor for Research at Vanderbilt. “We must translate the huge, decade-long expansion of NIH-funded basic science into good clinical practice with tangible, direct benefits to our patients.”
It won't be easy, cautioned David Lepay, M.D., Ph.D., who directs the FDA's Good Clinical Practice Program.
The public's faith in the safety and benefits of clinical research is tested when drugs are pulled from the market because of previously unrecognized adverse effects, and when isolated examples of research fraud become front-page news.
“The bottom line … is you can all do a brilliant job for years at a time, but when you fail at one thing, that is what you're going to be remembered for,” Lepay said. “All it takes is one individual doing something egregious, and the institution's reputation is down the drain.”
The FDA is redoubling its efforts to monitor drug safety in the pre- and post-marketing periods, to ensure that clinical research meets rigorous quality standards and to keep the public informed.
The research community also needs to encourage the detection, reporting and correction of poor research practices, Lepay said. For every 100 clinical researchers, an estimated one or two falsify their data or engage in other misconduct.
Don't be intimidated, Lepay said. “We don't challenge doctors generally in our culture, but … that is one of the things we have to build into the clinical trial system. How do we receive and respond to complaints?”
At Vanderbilt, concerns about the conduct of research can be addressed to the Institutional Review Board or the Research Support Service (part of the Office of Research), which was established and is directed by Gordon R. Bernard, M.D., assistant vice chancellor for Research.
“We handle these issues very, very carefully,” Bernard said.
Surveys indicate that people prefer to learn about clinical trials from their doctors, and yet usually get their information from the news media. Lepay said physicians, whether or not they are involved in research, need to become better educated so they answer their patients' questions.
“This is a conversation that has to be had,” he said.