• All clinical trials, other than exploratory trials,2 should be submitted for listing in a free, publicly accessible clinical trial registry within 21 days of the initiation of patient enrollment, unless there are alternative national requirements.

  • The registry should contain basic information about each trial sufficient to inform interested subjects (and their health care practitioners) about how to enroll in the trial. This would include, at a minimum, the following information: brief title; trial description in lay terminology; trial phase; trial type (e.g., interventional); trial status; trial purpose (e.g., treatment, diagnosis, prevention); intervention type (e.g., drug, vaccine); condition or disease; key eligibility criteria, including gender and age; the location of the trial; and contact information. Industry is also prepared to explore the concept of placing additional protocol information in a secure, non-public, third-party electronic repository3 for subsequent disclosure to medical journals when publication is sought.

  • Each trial listed in the registry should be given a unique identifier to ensure transparency of clinical trial results. The unique identifier should permit registry users to track the trial through multiple databases, including clinical trial results databases.

  • Registration of clinical trials on any one of a number of internet-based registries may achieve these objectives. The clinical trial registry maintained by the National Library of Medicine in the US at www.clinicaltrials.gov is already in place and can be used for this purpose, regardless of where the trial is conducted.

Clinical Trial Results Database

A clinical trial results database serves as a repository for the summary results of completed clinical trials. The innovative pharmaceutical

2  

Throughout this document the phrase “all clinical trials, other than exploratory trials” is intended to have the same meaning as the terms “hypothesis-testing clinical trials,” also known as “confirmatory clinical trials” as defined in the ICH Harmonised Tripartite Guideline E9. Statistical Principles for Clinical Trials. Stats Med 1999; 18:1905–42. Whereas exploratory trials serve to set direction (i.e., to generate hypotheses) for possible future studies, “hypothesis-testing trials” serve to examine pre-stated questions (i.e., to test hypotheses) using statistically valid plans for data analysis and provide firm evidence of safety and/or efficacy to support product claims.

3  

An example exists in Europe where recent legislation set up a database, “EudraCT,” containing information on all interventional clinical trials of medicines initiated in the Community from 1 May 2004. “EudraCT” is accessible to European Regulatory Authorities from the time of data submission (i.e., trial initiation). Some data fields will subsequently be made publicly accessible once the product is approved.



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