PARTICIPATION BY WOMEN AND MEN IN CLINICAL TRIALS. A GAO analysis of 36 NDAs (New Drug Applications) to the FDA involving 177,000 subjects found that 52% of volunteers were women. However, the small-scale safety (Phase 1) trials for those NDAs were performed in a predominantly male (67%) population.
 

NATIONAL AWARDS PROGRAM FOR EXCELLENCE IN THE PROTECTION OF HUMAN RESEARCH SUBJECTS. The Office of Human Research Protections (OHRP) has contracted with the Health Improvement Institute to create a national awards program recognizing excellence in the protection of human research participants. The awards will be part of a public-private partnership highlighting best practices by rewarding institutions, investigators, sponsors and review boards for their commitments to the responsible conduct of human studies. The nominations process will be announced later this year.
 

NEW AHC WEB SITE FOR CLINICAL TRIALS. The new AHC Clinical Trials web site (http://www.ahc.umn.edu/trials) has more than 60 active clinical trials listed. Any principal investigator may list her/his IRB-approved, active clinical trials so that sponsors and the general public are aware of the clinical research activities taking place at the University of Minnesota. Patients and potential volunteers have access to a listing of active trials. Any individual can volunteer to be contacted by the designated contact person for possible participation in a trial. PIs will be notified of potential volunteers by automated email and will follow-up with these potential volunteers. Volunteers can also request that their name be kept on file and that they be contacted for future clinical trials in specified areas.

Please support the web site and list all of your active clinical trials. Questions regarding the web site should be directed to the AHC Office of Research (625-1109).