Clinical trials are the lifeblood of medical science and critical to progress in the development of new drugs and therapies. Speakers in a recent symposium sponsored by the Emory University School of Medicine Clinical Trials Office addressed the strategies for improving public trust and participation in clinical trials and research.
"We continuously train our staff and faculty on the responsible conduct of research," says Carol Means, RN, CCRC, senior program associate for institutional and industry relations. "We do our very best to uphold and upgrade the faith and confidence that our public invests in us to honor and dignify their status as a research study volunteer, but most importantly, guard their safety. The symposium was geared towards raising awareness and suggesting strategies for strengthening our skills in this area."
Philip Ninan, MD, professor of psychiatry and behavioral sciences, Emory University School of Medicine, discussed one leading prescription for reform -- the requirement that all clinical trials be publicly registered.
"Registration of clinical trials is an idea whose time has come," says Dr. Ninan, also the director of the Mood and Anxiety Disorders Program at Emory. "It will provide transparency and enhance confidence in treatment recommendations. However, there are concerns of unintended consequences. Will industry shy away from studies because of proprietary concerns or avoid sponsoring studies because of a risk of adverse events?"
An editorial in the September 16, 2004 issue of the New England Journal of Medicine included a statement regarding clinical trial registration from the International Committee of Medical Journal Editors (i.e. JAMA, NEJM, The Lancet, Annals of Internal Medicine, etc.) Any trial that begins clinical enrollment after July 1, 2005 will require registration in a public trials registry before being considered for publication. That registry will be a full one. The website www.ClinicalTrials.gov, maintained by the National Institutes of Health, currently has 3,006 studies registered from NIH itself, 195 studies from other federal agencies, 857 studies sponsored by industries and 1,852 university/organization registered studies.
In the Oct. 28 symposium at Emory, Chris Pascal, JD, stressed the importance of raising the bar for research integrity and strategies to maintain it. Pascal is the director of the Office of Research Integrity for the Department of Health and Human Services. Research misconduct, Pascal says, can include but is not limited to falsification, plagiarism, dishonesty in reporting research results and a significant departure from accepted practices.
"We should be transparent," Pascal said. "There is a lot of pressure on researchers and scientists to get published and funded."
Participants were also educated through a lecture focused on "Educating, Engaging and Empowering Volunteers in Human Research Trials," presented by Roni Thaler, president of the Center for Information and Study on Clinical Research Participation (CISCRP).
Based on a survey conducted by CISCRP of 1,587 persons responding to a web-based survey, 41 percent cited insufficient and hard to access information as their reason for not participating in clinical trials. In addition, 21 percent said there were no appropriate trials in their community, 20 percent were concerned about risks and 14 percent said that the medical community didn't encourage participation.
Thaler also reviewed statistics from Harris Interactive that show that out of 1,587 survey respondents in 1996, 28 percent did not trust the information received from clinical research professionals. In 2002, the number jumped to 75 percent for public distrust.
"Without the volunteer participants there will be no drugs and there will be no medical therapies," Thaler said.