Clinical trials are the foundation on which treatments and cures are built. But Dr. Christopher Coffey, professor and director of the Clinical Trials Statistical Data Management Center in the University of Iowa College of Public Health, says a poorly designed and executed trial can be wasteful and does not help people who have neurological disorders.
The Universities of Iowa and Michigan have created an annual training program for junior neurology faculty and fellows from institutions across the country that teaches participants how to design stronger trials that are more apt to be funded and completed. It not only increases the number of trials that could lead to treatments and cures, it encourages young faculty to pursue research.
Clinical trials are research studies in which new drugs, techniques, and other therapies are tested on human subjects to determine their effectiveness as they move from the lab to the clinic. They are scientifically rigorous, highly regulated, and expensive, which means potential funding agencies want to make sure the investigators have a well-designed trial before approving any grants.
The Iowa-Michigan collaboration, called the Clinical Trials Methodology Course, is designed to reduce the number of trial proposals for neurology and the brain sciences that are rejected either because the trial is poorly designed or the grant application is poorly written. Participants submit a proposal for a small clinical trial and a grant as part of their application to the program. The proposal is then reviewed by small groups of senior faculty, biostatisticians, and National Institutes of Health (NIH) experts that meet online every week for about six months starting in April.Friday Letter Submission, Publish on September 06