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. Effective December 2011, the study results maintained in the ClinicalStudyResults.org database were transferred to Merck.com because of PhRMA's announcement that the database will be removed by the end of 2011. Registration and the posting of results 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.
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 healthcare providers to learn about and gain access to relevant clinical trials of experimental treatments or preventative agents. 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 United States. 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 30 days after the product is marketed in the United States or within 12 months after the last patient's last visit for the primary outcome occurs, whichever is later.
For many years, Merck has been committed to publishing results of hypothesis-testing trials, predating recent questions about the publication of such data. We expanded our commitment in 2007 by disclosing results from registered trials of marketed products, as noted above in the introduction of this section. Merck’s Guidelines for Publication of Clinical Trials and Related Works are posted online. These guidelines contain additional information about how Merck works with external authors and contributing writers. We also adhere to the International Committee of Medical Journal Editors (ICMJE) guidelines for authorship, requiring that authors:
We also adhere to the authorship criteria of other, respected biomedical journals if their criteria differ from those of the ICMJE. 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 that we hire 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.
We also adhere to ICMJE or journal-specific guidelines for disclosure of potential conflicts of interest for the full author team. Reported potential conflicts of interest include both financial and nonfinancial ones.
In July 2011, Merck introduced its latest transparency policy around its clinical trials. Called the Protocol Transparency Initiative, this voluntary practice involves providing the clinical study protocol to biomedical journals when submitting a manuscript on a clinical trial, allowing journal editors and peer reviewers to use this protocol in their evaluation of the manuscript for publication. Furthermore, if the journal accepts the manuscript, Merck allows the journal-at its sole discretion-to post key sections of the protocol on its website when the manuscript is published.
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, we 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 our position on clinical trial registries, click here.
In addition to disclosing results of clinical trials, we respond to requests from external researchers to share Merck clinical trial data. We have multiple clinical trial databases that are of high value to the external clinical research community. We evaluate 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.