TABLE 3–1 Required Data Fields for the DHHS Clinical Trial Registry at ClinicalTrials.gov

Unique Protocol ID Number

Study Sponsor

Verification Date

Brief Title (in lay language)

Brief Summary (in lay language)

Study Design, Study Phase, Study Type

Condition or Disease

Intervention

Study Status

Eligibility Criteria/Gender/Age

Location of Trial

Contact Information

Although ClinicalTrials.gov has been a valuable tool to enable patients and health care providers to understand the research occurring in various therapeutic areas and to locate clinical trials in which to enroll, it has certain limitations within its legislative mandate:

  • It applies only to serious and life-threatening conditions.

  • There is no mechanism to ensure compliance by all entities performing clinical trials.

  • It does not include disclosure of study results.

  • Required data fields are not always completed in an informative manner.

For these reasons, several groups have called for the mandatory registration of additional clinical trials as well as the registration of more extensive clinical trial information and the posting of a summary of clinical trial results. In addition, a number of clinical trial registries have been created in the public sector and by several pharmaceutical companies. The most prominent, and probably influential, proposals for registry requirements—by the International Committee of Medical Journal Editors (ICMJE), the international pharmaceutical industry and, most recently, the World Health Organization (WHO)—were presented at the workshop and are described below.



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