Merck of the US has announced that it 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.
The update to its publications policy is part of Merck’s “continuing, voluntary commitment to increase transparency about how it conducts business”, the company says. Previously it only submitted 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 website, 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 notes.
Tuesday, July 05, 2011
Merck commits to increased transparency on study protocols
via pharmatimes.com
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