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Merck commits to sharing study protocols

Tuesday, July 5, 2011 12:24 PM

Merck will voluntarily include the research protocol and statistical analysis plan among the materials it supplies to medical journals when it submits clinical study manuscripts for publication, according to a PharmaTimes report.

The update to its publications policy is part of Merck’s “continuing, voluntary commitment to increase transparency about how it conducts business,” the company said. Previously, it submitted only research protocols and statistical analysis plans to journals on request. 

Once a medical journal has accepted a Merck manuscript for publication, the company will give the journal the opportunity to post on its web site, at the journal’s own discretion, the key sections of the research protocol.

These would include 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, the company said.

“To ensure that information proprietary to the company is not made available publicly,” though, Merck will require certain sections, including the ‘background’ and ‘rationale’ parts of the study protocol, to be redacted before they are posted on a journal’s web site.

“The company will, however, always provide the full, non-redacted protocol to journal editors,” it added.

Proactive sharing of 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,” said Dr. Michael Rosenblatt, Merck executive vice president and chief medical officer.
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