“DRUGMAKERS PREFER SILENCE ON TEST DATA.” According to the Washington Post (July 6, 2004) many pharmaceutical firms have repeatedly violated U.S. law by not registering trials with the government database ( www.clinicaltrials.gov ), according to the Food and Drug Administration. The 1997 requiring registration law is apparently so little known that scientific journal editors and professional medical associations have recently debated whether to create a system of private incentives for disclosure of trials. An FDA analysis found that in 2002 only 48 percent of trials of cancer drugs had been registered, and a preliminary review now indicates the listing rate for drugs for some other serious diseases is in the single digits. ClinicalTrials.gov lists 5,754 ongoing studies, but only 13 percent are industry sponsored; the majority is from the NIH.

HHS PROPOSES IRB REGISTRATION. The Office for Human Research Protections (OHRP) of the Department of Health and Human Services (HHS) plans to require registration of all institutional review boards (IRBs) that are designated under a federal assurance of compliance. The proposed new rule is available at: http://a257.g.akamaitech.net/7/257/2422/06jun20041800/edocket.access.gpo.gov/2004/pdf/04-14679.pdf .

ORGANIZATIONAL CHANGES AT FDA FOR ONCOLOGY. The Food and Drug Administration (FDA) plans to reorganize its approach to the review of drugs and therapeutic biologics used to diagnose, treat, and prevent cancer. The FDA is creating a new office, the Office of Oncology Drug Products (ODP), to be housed in the Center for Drug Evaluation and Research (CDER). This new office will consolidate three existing areas within CDER. More information can be found at http://www.fda.gov/bbs/topics/news/2004/NEW01091.html .

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.

The Fall 2004 training course is planned as follows:

Module 2. Practical Aspects of Clinical Research - Mondays and Wednesdays, October 4 - 13, 2004 from 3:00 - 5:00 p.m. Topics will include:

* Overview of Research Regulations and Good Clinical Practice Guidelines Roles and Responsibilities of Investigators and Sponsors

* The Clinical Trial Protocol and Investigator's Brochure

* The Consent Form and Consent Process

* Essential Documents for the Conduct of a Clinical Trial

* Adverse Event Reporting

* From New Protocol to Final Approval: Getting a Clinical Trial through the System

* The Research Services Organization

Module 3. Navigating the University Environment - Monday and Wednesday, October 18 and 20, 3:00 - 5:00 p.m. Presentations from the following groups will be given - and groups with application processes will discuss their forms/process:

* Office of Regulatory Affairs 

* Institutional Review Board 

* Environmental Health and Safety (including Institutional Biosafety Committee and Radiation Protection) 

* Office of the General Counsel (Academic Misconduct) 

* Sponsored Projects Administration 

* Academic Health Center Office of Research 

* Investigational Drug Services 

* Investigational New Drug/Investigational Device Exemption Assistance Office 

* General Clinical Research Center 

* Cancer Protocol Review Committee 

* Protocol Review and Data Use Committee 

This free program is open to all AHC employees , but pre-registration is required. To register for Modules 2 and 3, send your name, contact information, and module numbers you plan to attend to rso@umn.edu. The exact location in Moos Tower will be announced in the September RSO Newsletter.