A National Survey of Provisions in Clinical-Trial Agreements between Medical Schools and Industry Sponsors Kevin A. Schulman, M.D., Damon M. Seils, M.A., Justin W. Timbie, B.A., Jeremy Sugarman, M.D., M.P.H., Lauren A. Dame, J.D., M.P.H., Kevin P. Weinfurt, Ph.D., Daniel B. Mark, M.D., M.P.H., and Robert M. Califf, M.D. ABSTRACT Background Concerned about threats to the integrity of clinical trials in a research environment increasingly controlled by private interests, the International Committee of Medical Journal Editors (ICMJE) has issued revised guidelines for investigators' participation in the study design, access to data, and control over publication. It is unclear whether research conducted at academic institutions adheres to these new standards. Methods From November 2001 through January 2002, we interviewed officials at U.S. medical schools about provisions in their institutions' agreements with industry sponsors of multicenter clinical trials. A subgroup of the respondents were also asked about coordinating-center agreements for such trials. Results Of the 122 medical schools that are members of the Association of American Medical Colleges, 108 participated in the survey. The median number of site-level agreements executed per institution in the previous year was 103 (interquartile range, 50 to 210). Scores for compliance with a wide range of provisions — from ensuring that authors of reports on multicenter trials have access to all trial data (1 percent [interquartile range, 0 to 21]) to addressing the plan for data collection and monitoring (10 percent [interquartile range, 1 to 50]) — demonstrated limited adherence to the standards embodied in the new ICMJE guidelines. Scores for coordinating-center agreements were somewhat higher for most survey items. Conclusions Academic institutions routinely engage in industry-sponsored research that fails to adhere to ICMJE guidelines regarding trial design, access to data, and publication rights. Our findings suggest that a reevaluation of the process of contracting for clinical research is urgently needed. Source Information From the Center for Clinical and Genetic Economics (K.A.S., D.M.S., J.W.T., K.P.W.), the Outcomes Research and Assessment Group (D.B.M.), Duke Clinical Research Institute (R.M.C.), and the Center for the Study of Medical Ethics and Humanities (J.S., L.A.D.), Duke University Medical Center; and the Duke University School of Law (L.A.D.) — all in Durham, N.C. Address reprint requests to Dr. Schulman at the Center for Clinical and Genetic Economics, Duke Clinical Research Institute, P.O. Box 17969, Durham, NC 27715, or at kevin.schulman@duke.edu. NEJM Volume 347:1335-1341 October 24, 2002 Number 17 Remember we are NOT Doctors and have NO medical training. This site is like an Encylopedia - there are many pages, many links on many topics. Support our work with any size DONATION - see left side of any page - for how to donate. You can help raise awareness of CAM.