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Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Summary
A clinical trial registry that follows these principles could be expected to meet the following goals:
To provide patients and their health care providers with adequate and reliable information about clinical trials that may be enrolling patients.
To provide health care providers, patients, and others with the results of a clinical trial once the trial is completed and the product is available for prescription.
To link each clinical trial initiated with a reported outcome, thereby preventing selective or biased reporting of results.
To meet the first three goals in a way that protects proprietary research data, as necessary, and preserves innovation.
However, a clinical trial registry is NOT intended to replace the advice of a health care professional regarding benefits and risks nor is it intended to replace the comprehensive information on a product label as required by the relevant regulatory authorities. It is also not intended to replace peer-reviewed publication—although the veracity of journal publications could be better assured by the presence of a transparent and more comprehensive mandatory clinical trial registry. Furthermore, to meet its purposes, a registry should provide only objective, scientific information about the clinical trial and not promote a product.
Comments on Guiding Principles and Goals for Clinical Trial Registries
Marjorie Speers, Executive Director of the Association for the Accreditation of Human Research Protection Programs, began her workshop presentation about the needs of patients and the public by stating that, in the debate over registries, the purposes of such registries have been blurred. Are they intended merely to inform the public about an ongoing or proposed clinical trial? Are they intended to be vehicles to recruit individuals into clinical trials? Are they intended to assist physicians in treating patients? Are they intended to prevent the suppression of negative results? Are they intended to build the public’s trust in clinical trials? All of these purposes have been expressed at one time or another.
Alan Breier, Vice President, Medical and Chief Medical Officer, Eli Lilly and Company, suggested that different platforms might be needed