RSO CLINICAL TRIALS ACTIVITY. The RSO is currently providing start-up services and a research coordinator (full service) for 30 currently active projects. In addition, the RSO has provided start-up services for 47 currently active projects. There are 18 more projects in the active approval stage. Despite this growing portfolio which keeps our staff well occupied, we are always eager for new research projects with which to assist faculty.
 

BEST SPONSORS/WORST SPONSORS. CenterWatch regularly surveys clinical investigative sites to determine who are the most and least appreciated sponsors. This year, the highest marks went to GlaxoSmithKline, Merck, Biogen, Pfizer, and Lilly. Earning lowest marks were Roche, Boehringer-Ingelheim, Sanofi-Synthelabo, Schering-Plough, and Abbott Laboratories.
 

COMPLAINTS AGAINST INVESTIGATORS TO THE FDA. Between 1998 and 1999, the number of complaints received by the FDA against investigators for alleged violations of Good Clinical Practice increased tenfold, perhaps as a consequence of increased public attention to clinical trials. In 2000, the number of complaints increased 10% to 118. Approximately half of all complaints led to formal investigations and one-quarter led to disqualification of an investigator from further FDA-regulated research.
 

CHALLENGES OF SMALL CLINICAL TRIALS. The Institute of Medicine has published a report discussing performance of clinical trials where the number of participants is limited (rare diseases, public health emergencies, and astronauts—hence NASA’a interest in the subject). Recommendations for research design and analysis can be found at http://www.nap.edu/books/0309073332/html/.
 

A DIFFERENT APPROACH TO DEALING WITH THE INFLUENCES OF PHARMACEUTICAL COMPANIES ON CLINICAL TRIALS. Marcia Angell, former editor of the New England Journal of Medicine, has suggested that the feds develop an independent public agency to oversee performance of clinical trials, similar to a contract research organization (CRO), but without the financial conflict of interest by current participants. Speaking at an ethics conference at the NIH, Angell described such a plan as a return back to the situation when academic health centers were the sites of investigator-initiated and -analyzed clinical trials.