Merck is committed to the timely registration of clinical trial information and the disclosure of trial results—regardless of their outcome.

In response to physician and patient requests for improved information, Merck registers clinical trials at ClinicalTrials.gov and has been posting results of clinical trials at the site since October 2008. Prior to October 2008, Merck posted results of clinical trials to ClinTrialResults.org. This provides patients and physicians with information about clinical trials that are open and recruiting patients, and it enables researchers who analyze, report or publish the results of clinical trials to have timely information about our medicines and vaccines.

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 changing global requirements and update our clinical processes and practices to make sure the company is compliant.

For those who analyze, report or publish the results of clinical trials, a clinical trial registry also provides 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 were completed in 2002 or later, and posted results for marketed products. Since February 2007, Merck's policy has been to register at initiation 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 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 ClinTrialResults.org. However, it is now our practice to post results at ClinicalTrials.gov. A synopsis will be posted online the first date a product is marketed in the United States or within 12 months after the last patient's last visit of the primary outcome occurs, whichever is later.

Disclosure of Clinical Trial Results

For many years, Merck has been committed to publishing results of hypothesis-testing trials, predating 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 in the introduction of this section. 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.

Merck also adheres to the ICMJE guidelines for disclosure of potential conflicts of interest for the full author team. These guidelines were formalized and released by the ICMJE in July 2010. Reported potential conflicts of interest include both financial and nonfinancial ones. Before the ICMJE guidelines were formalized, Merck reported potential conflicts of interest to journals that accepted Merck's clinical trial manuscripts for publication.

Merck complies with all applicable laws and regulations associated with registration of clinical trials and posting results. If a clinical trial of a marketed product is terminated early for safety reasons, Merck will promptly disclose medically important information to regulatory authorities and the public, update the 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 last visit occurs. If terminated for efficacy reasons, the results will be disclosed within 12 months after the last patient's visit occurs. Summaries of terminated trials will 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 in compliance with applicable privacy and data protection laws, rules and regulations.