Clear Road Ahead - Pharmaceutical Executive

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Clear Road Ahead
An industry standard for publicizing clinical-trial results is a ways off. But pharma's openness to more transparent procedures is moving things in the right direction.


Pharmaceutical Executive



Rochewww.roche-trials.com
The PhRMA principles In 2002, PhRMA issued its "Principles on the Conduct of Clinical Trials and Communication of Clinical Trial Results," in which member companies committed to registering "all company-sponsored hypothesis-testing (non-exploratory) clinical trials conducted on drugs and biologics marketed in the US or intended for marketing in the US, regardless of disease studied or the location of the trial." Hypothesis testing may occur at any stage of drug development and includes all Phase III studies, some earlier-phase studies, and many studies of marketed products. Because of the proprietary nature of exploratory studies, PhRMA specifically excluded them, unless the results were of medical significance.

In October 2004, PhRMA formally launched its own clinical-trial database at http://www.clinicalstudyresults.org/, a centralized, voluntary repository for study results for products marketed in the United States. PhRMA urged all companies to post unpublished results within 12 months of completion of a trial. According to the organization, information on 136 drugs is available on the site. In January, PhRMA issued a new clinical-trial registry proposal: By July 1 pharma companies were to voluntarily post details on all newly initiated hypothesis-testing clinical trials at study initiation, either on their corporate Web sites, at http://www.clinicaltrials.gov/, or at http://www.clinicalstudyresults.org/. Ongoing hypothesis-testing trials were to be posted by September 13, 2005. To meet minimum standards, these postings must include:

  • study description in easily understood terminology
  • study purpose, type, and phase
  • study status
  • type of intervention
  • illness or condition studied
  • inclusion/exclusion criteria
  • site location and/or contact information.

Beyond these minimum requirements, the proposal called for companies to:

  • provide information on studies conducted outside of the United States
  • develop standards for verifying adherence to these guidelines

•use a unique identifier for trials to permit easy cross-reference (trials listed on clinicaltrials.gov are already given a unique identifier)

  • place protocols with a secure third party for later disclosure.

American Medical Association The AMA also became involved in the registries issue in late 2004. In September 2004, AMA trustee Ronald M. Davis, MD, speaking before the House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations, outlined five key elements needed to make a clinical-trials registry effective:

1. The system should include all trials, Phase II through IV, of drugs, biologics, and devices.

2. Identifying information, including study sponsor, unique identifier, funding entity, and contact information for responsible individuals, should be provided.

3. Name, purpose, and design of the study; the diseases and population being studied; key study dates, location; and patient-recruitment status should be supplied in an easy-to-understand format.

4. Results should be provided in a central repository, with links to sites containing additional published reports.

5. Participation should be considered a condition for approval by institutional review boards (IRBs).


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