similarly designed trials with the same agents may have drawn different conclusions.

Usually a body of evidence, rather than a single trial, is required to influence the thinking of clinicians, researchers, patients, and medical policy experts. This body of evidence, in fact, forms the basis of regulatory review and approval of pharmaceutical products. Responsible decision making requires awareness of both positive and negative clinical trial results, along with confidence that the findings are available and accessible.

Accordingly, key stakeholders in the medical community have suggested that if clinical trials were registered in a systematic fashion at their inception, followed by the posting of summary results for the study, and both were easily accessible to interested parties, then the full range of clinical evidence surrounding an investigative therapy would become part of the public record. In addition, once a drug has been approved, the registry provides a complete record that can serve as input for decisions by guideline developers, insurers, and those who monitor quality of care in the United States.

DIVERSE EXPECTATIONS AND PERCEIVED NEEDS

The public and various entities within the medical community have different expectations and perceived needs regarding a public clinical trial registry:

  • Individuals suffering from various diseases, and their family members, want to know that appropriate therapies are being offered and that patient safety is being secured. In addition, more and more patients today want the ability to search on their own for research that pertains to their disease and potentially to enroll in a clinical trial if suitable.

  • Health care professionals need both unbiased summary information derived from all trials conducted on a drug or therapy, and the capacity to look at the clinical data from any single study. They do not want to confine their review to the approved drug labeling or articles published in medical journals.



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