Merck statement on voluntary submission of clinical research protocols
Posted: 1 July 2011 | | No comments yet
For its investigational and approved products…
Today Merck said the company is strengthening its publications policy as part of its continuing, voluntary commitment to increase transparency about how it conducts business.
Effective July 1, when Merck submits a manuscript on a study of an investigational or an approved medicine or vaccine to a biomedical journal, Merck will include the protocol and statistical analysis plan as part of the submission package. Merck previously supplied this material only upon request. Upon a journal’s acceptance of the manuscript for publication, Merck will provide the journal with the opportunity to post on its web site, at journal’s discretion, the key sections of the protocol, including the objectives and hypotheses, patient inclusion and exclusion criteria, study design and procedures, efficacy and safety measures, the statistical analysis plan, and any amendments relating to those sections.
To ensure that information proprietary to the company is not made available publicly, Merck will require that certain sections, including the “background” and “rationale” sections of the study protocol be redacted prior to posting. The company will, however, always provide the full, non-redacted protocol to journal editors.
“It’s our responsibility to make available important information about our products and the science on which they are based, and do so in an objective, accurate and balanced way,” said Michael Rosenblatt, M.D., Merck executive vice president and chief medical officer. “Proactively sharing our study protocols will enhance the exchange of ideas within the scientific and medical community, and ultimately lead to a better understanding of the benefits and risks of our products among health care professionals and patients.”
About Merck’s Transparency Efforts
Merck is committed to industry-leading standards of transparency. This update to our publications policy is another significant step the company is taking to respond to stakeholder feedback and public interest across many aspects of our business, from research and development to sales and marketing practices. More information about Merck’s transparency initiative is available at www.merck.com/corporate-responsibility. Merck’s guidelines for publication of clinical trials are available at www.merck.com/research/discovery-and-development/clinical-development/Merck-Guidelines-for-Publication-of-Clinical-Trials-and-Related-Works.pdf.
