INNOVATION IN RESEARCH
Clinical Trials News: CPMC Markets Clinical Trials Tools

The CPMC Office of Clinical Trials is taking two of its successful programs into the marketplace. Its training program in Good Clinical Practice (GCP) and an administrative software package are being prepared to go on the market by December.

The GCP course, which has been completed by a large group of CPMC and affiliate clinical trials personnel, gives instruction on how to follow a set of guidelines used to protect the rights of human subjects, ensure the integrity of data, guarantee the reproducibility of data, and make the research methodology clear. In other words, GCP training ensures that those conducting clinical trials practice the same minimum standard level of excellence. Although GCP is practiced in most clinical trials, this particular course was designed at CPMC. A video currently in production will be offered along with a companion textbook for use in offices of clinical trials at other institutions.

"After having had at least 80 visits from other academic clinical trials sites, it became apparent that no other institution offers this kind of program," says Michael Leahey, director of the CPMC Office of Clinical Trials. "We are at least two years ahead of other programs and no one has the kinds of programs we do, so we may as well capitalize on our edge."

Dr. David Bickers, chairman of dermatology and of the CPMC Office of Clinical Trials advisory committee, says the GCP program has been so successful that it's only natural that other institutions are interested in using it. "Because of the efforts made here in developing such an excellent course and now because of interest elsewhere, we're making it available for sale. It's my belief that this course is so valuable that, ultimately, everyone involved in clinical trials should be required to participate in this training."

In addition to marketing the GCP video, Clinical Trials will be packaging software the staff has developed for office management. The package includes a data base that manages contracts and tracks investigators and their projects. "The concept of a centralized office of clinical trials was perfected by CPMC," says Mr. Leahey. "With $7 billion being spent annually for clinical trials nationwide and nearly $3 billion of that amount going to for-profit contract research organizations, I don't think helping other academic medical centers achieve administrative excellence will hurt us. Rather, it will further strengthen the role that academic medical centers play in clinical research nationally."

Mr. Leahey points out that having a standard administrative system in place at all academic medical centers helps in collaborations between institutions. "It's in our interest to have other places using our system because it enables us to better interact on joint ventures, while enhancing the appeal to companies that need to conduct trials in several regions."