Kudos To CEO Ken Frazier — New Merck’s Study Transparency Measures

Even though this item was dumped into “the memory hole” (released late on a holiday Friday), this news deserves mention — and significant praise. It is progress. Incremental progress, but progress just the same.

Merck will now make the various statistical analysis packages from all studies available to all — not just to those people who write in to request ’em (and then, as under prior practice, only to those Merck deemed worthy). Every little bit helps, right?

Right — here it is

. . . .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. . . .”

Quite so — and good show, Whitehouse Station.


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