Clinical Trial Registration

Merck has long been committed to publishing the results of our clinical trials, regardless of outcome, in a timely manner. We believe that clinical trial registries serve an important function for patients and their health care providers to learn about and gain access to relevant clinical trials of experimental treatments or preventative agents. Merck supports the revisions to the PhRMA Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results that were adopted in April, 2009. We continually assess the changing global requirements and update our clinical processes and practices to ensure the company is compliant.

A clinical trial registry also serves those who analyze, report or publish the results of clinical trials, by providing information on trials in progress and the ability to track such trials over the course of development. Beginning in 2005, Merck registered clinical trials that began or completed in 2002 or later, and posted results for marketed products. Since February 2007, Merck's policy has been to register at the trial initiation all clinical trials (Phases I-V in patients of investigational and marketed products in which treatment is assigned) that it sponsors and conducts worldwide on ClinicalTrials.gov. In keeping with our publication guidelines, Merck discloses balanced and accurate information regarding all of our registered clinical trials of marketed products, regardless of outcome. In addition, we disclose clinical trial results of marketed products on websites designed for this purpose in the U.S. Through December, 2008 we posted study results on ClinicalStudyResults.org. However, it is now our practice to post results at ClinicalTrials.gov. A synopsis will be posted online within seven days after registration of a product in the United States, European Union or Japan or within 12 months after the last patient has been evaluated by trial health professionals.

Merck currently is assessing provisions of the Food and Drug Administration Amendments Act of 2007, including those related to clinical trial registration and results posting. As the requirements are implemented, Merck and other companies are developing and establishing processes necessary for compliance with all of the new law's provisions, including providing the clinical trial results in the specified format.

Merck follows the Food and Drug Administration Modernization Act (FDAMA) requirement to post information on ClinicalTrials.gov about clinical trials designed to treat life-threatening or otherwise serious illnesses, regardless of phase. Information posted by Merck allows patients to identify potentially appropriate trials for their disease conditions and pursue participation by calling a central contact number for further information.

Disclosure of Clinical Trial Results

For many years, Merck has been committed to publishing results of hypothesis-testing trials, pre-dating recent questions about the publication of such data. Merck expanded our commitment in 2007 by disclosing results from registered trials of marketed products, as noted above. Merck formally developed and implemented our Guidelines for Publication of Clinical Trials and Related Works in 2003, and posted them publicly online in January 2004. The guidelines contain additional information about how Merck works with external authors and contributing writers. Merck adheres to the International Committee of Medical Journal Editors guidelines for authorship, requiring that authors:

• Make substantial contributions to study conception and design, or acquisition of data, or analysis and interpretation of data.
• Draft the article or revise it critically for important intellectual content.
• Give final approval of the version to be published.
  

In addition, individuals who do not meet criteria for authorship but who provide support are recognized in acknowledgments when the manuscript is published. Merck staff or contract writers hired by Merck may facilitate the development of a manuscript when the lead author provides oversight and direction; the efforts of the writers will then be acknowledged in the publication.

In addition to publishing our clinical trial results, Merck posts summaries of results from clinical trials of our marketed products along with bibliographic citations of published trials at ClinicalTrials.gov. Until December 2008, Merck posted summaries to ClinicalStudyResults.org. Merck complies with all applicable laws and regulations associated with registration of clinical trials and posting results. Merck continues to assess all provisions of The Food and Drug Administration Amendments Act of 2007, including those related to clinical trial registration and results posting.

If a clinical trial of a marketed product is terminated early for efficacy reasons, the results will be disclosed within 12 months after the last patient has been evaluated by trial health professionals. However, if a trial is terminated for safety reasons, Merck will promptly disclose medically important information to regulatory authorities, health care providers and the public, update the trial status on clinicaltrials.gov within 30 days, and submit a manuscript to a journal (or post a summary online) within 12 months after the last patient's evaluation. Our summaries of terminated trials provide information about patient disposition, safety and adverse experiences, as well as an explanation for why the trial was terminated early. For Merck's position on clinical trial registries, click here.

Access to Merck Clinical Databases

In addition to disclosing results of clinical trials, Merck responds to requests from external researchers to share Merck clinical trial data. Merck has multiple clinical trial databases that are of high value to the external clinical research community. Merck evaluates each request based on criteria that balance the need to advance science with the need to protect intellectual property and confidential information, and to comply with applicable privacy and data protection laws, rules and regulations.

The content on this page was last modified on September 15, 2009.

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