NATIONAL LISTING OF CLINICAL TRIALS AT ClinicalTrials.gov. The Clinical Trials Data Bank was established under the FDA's Modernization Act. It is a public resource for information on IND studies of drugs and biologicals under study for treating serious or life-threatening diseases and conditions. The Data Bank will also accept information about other clinical trials, which are not for serious diseases or under an IND or to test effectiveness. Anyone interested in participating in a study can view the listings at www.ClinicalTrials.gov. Submission of information on IND studies of drugs and biologicals to treat serious or life-threatening diseases and conditions is required by Federal law. The IND/IDE Assistance Program will serve as the University's administrator for the determination of applicability and submission of information. This obligation only applies to you if you are the IND sponsor. (If you are an investigator under a commercial IND , it is the sponsor's obligation to list the trial). If you have any questions or require assistance, please see www.ahc.umn.edu/research/ind-ide or contact Harvey Arbit at 5-0930 or arbit002@umn.edu .

NIH DECLINES TO USE MARCH-IN RIGHTS TO LOWER MEDICATION PRICE. The NIH has decided against making the patented HIV-drug, Norvir (ritonavir) available for competitive manufacture and pricing. The NIH denied a petition by patient and consumer activists to use the NIH's "march in" rights as defined in the Bayh-Dole Act, which encourages recipients of federal research funds to patent inventions arising from that research. The Bayh-Dole Act allows the government to override licensing rights if there is a particular public health interest. The petitioners argued that the high cost of this drug was not in the public interest. The NIH found that the statutory and regulatory framework does not warrant march-in. Former Sen. Birch Bayh testified that the intent of the Act was not that it should be used to control the commercial price of an invention. NIH did comment that "the issue of drug pricing has global implications and, thus, is appropriately left for Congress to address legislatively."

WOULD YOU LIKE FREE CLINICAL RESEARCH TRAINING? The AHC offers an introductory course based on the International Code of Harmonization (ICH) Good Clinical Practice (GCP) guidelines. This training course is offered twice each year to AHC clinical research investigators, coordinators, administrative employees, or any AHC employee who wants to learn more about the guidelines and processes for conducting clinical trials.

Past participants in this course have included physicians, research coordinators, basic scientists with an interest in clinical trials, department financial analysts/administrators responsible for managing clinical research accounts, and administrators from other University areas. Length of participants' clinical research experience has ranged from none to more than 15 years. Evaluations of these training sessions have been uniformly and enthusiastically positive. Complete program information can be viewed at www.ahc.umn.edu/research/rso/information/training/clinicaltraining/ . This free program is open to all AHC employees, but pre-registration is required. To register, send your name, contact information, and module numbers you plan to attend to rso@umn.edu .