In a move designed to substantially expand its corporate-sponsored clinical drug research, Johns Hopkins Medicine has signed a non-exclusive agreement with Quintiles Transnational Corp., the world's largest contract pharmaceutical organization.
Under the agreement, Quintiles will collaborate with Johns Hopkins on clinical research opportunities. Quintiles Transnational Corp., headquartered near Research Triangle Park, N.C., specializes in accelerating the health care product development and launch process from preclinical trials through marketing and sales.
CenterWatch Inc., a Boston-based company that monitors the clinical trial industry, projects that for 1998 there will be about 9,000 clinical studies involving as many as 45,000 individual grants coming from the pharmaceutical industry.
"This new partnership could greatly expand our access to important clinical trials, giving our patients access to newer and possibly better medications," said Bart Chernow, vice dean for research and technology at the School of Medicine.
Working with medical institutions like Hopkins enhances Quintiles' ability to improve and accelerate drug development because it can offer the drug companies access to top clinical investigators, Chernow says.
"We anticipate that Quintiles would approach Hopkins regularly with collaborative opportunities," Chernow says.
In this fiscal year, Hopkins has 496 ongoing clinical trials.
Anticipating an influx of new trials, Chernow has expanded a Hopkins Department of Medicine unit that coordinates clinical trials to include any School of Medicine departments appropriate to a Quintiles contract. The new Johns Hopkins Clinical Trials Unit will match a trial with all potential investigators, according to the unit's director, endocrinologist Adrian Dobs, associate professor, Medicine. "This gives the drug industry an easier way to place its study and offers investigators a way to market their expertise in a coordinated and efficient way," he said. In addition, the unit will provide other clinical trial research-related services to investigators. A master clinical trial agreement also in place with Quintiles will facilitate the start-up of studies.
Both Chernow and Dobs emphasize that every trial brought by Quintiles must pass Hopkins' rigorous ethical, institutional and scientific review process as well as have approval from the U.S. Food and Drug Administration.
Quintiles Transnational Corp., which has offices in 28 countries and 13,000 employees, provides full-service contract research, sales and marketing, health care policy consulting and health information management services to pharmaceutical, biotechnology, medical device and health care industries.