• Delayed Disclosure Mechanism. For proprietary reasons, speakers from industry argued for the delayed disclosure of certain fields (i.e., at project initiation, not disclosing the hypothesis statement, primary and secondary outcome measures, and projected year of trial completion) for a minority of trials. However, the workshop did not discuss implementation questions such as what is meant by “delay” (in terms of time or staging in the marketing process) or whether there should be objective criteria for when industry would invoke such a delay. More work is needed to reach agreement on whether delayed disclosure is an acceptable approach and, if so, to define processes for authorizing these delays. An option that might accompany delayed disclosure is to store the data in a non-public part of the registry.

  • Reporting Results of Completed Trials. The International Committee of Medical Journal Editors (ICMJE) does not call for results to be reported. The World Health Organization (WHO) calls for the reporting of results once a trial is completed. The Joint Position of the pharmaceutical industry calls for reporting of results for products that are brought to market in any country. As the interested parties continue to discuss and seek a resolution to the issue of reporting results, the other purposes of a clinical trial registry can be met.

  • Compliance. Incentives for complying and consequences for not complying with registry requirements would seem necessary for a registry to be comprehensive. Possible roles for Institutional Review Boards, the Food and Drug Administration, and others were discussed, but this is still a controversial topic.

Activities toward a comprehensive, publicly accessible clinical trial registry continued after the workshop. Depending on when a clinical trial started, it has to be registered before enrolling the first patient or (for trials initiated before July 1, 2005) before submitting an article to an ICMJE journal. The international pharmaceutical industry working with the National Library of Medicine (NLM) has begun registering all but exploratory clinical trials on ClinicalTrials.gov, and providing the results of clinical trials on marketed products on ClinicalStudyResults.gov, an Internet database launched in September 2004 by the Pharmaceutical Research and Manufacturers of America. These new efforts are being monitored closely on the pages of the medical journals. Zarin and col-



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