Merck believes clinical trial disclosure rules must distinguish between hypothesis-generating and hypothesis-testing trials.

"Exploratory or pilot studies...should be treated somewhat differently" than "confirmatory trials," Merck Executive Director-Medical Communications Larry Hirsch, MD, told an Institute of Medicine Clinical Research Roundtable Sept. 2.

Merck's position is "very clear," Hirsch said. "Regardless of outcome, we commit to publish the results of all hypothesis-testing trials we conduct."

Merck defines those as trials "statistically designed and powered to test hypothesis to provide the ability to draw firm conclusions about the safety and/or efficacy of a product or an intervention," Hirsch explained.

However, "exploratory or pilot studies are proprietary to the company," though "we will publish these if the results are of medical importance, and that is a joint decision between the company and the investigators."

"We believe that commitment largely addresses the issue of partial disclosure of information."

Requiring publication of exploratory, hypothesis-generating trials "gets to the issue about proprietary nature of information," Hirsh said.

"I'm not talking only about patents," Hirsch added. "The design of our clinical trials, the endpoints that we're measuring, the methods of analysis, the timing of those trials, how they are being done, in other words, is extremely critical information."

There are "things about Merck's pipeline, including late development programs, that are not in the public domain, and I have to assume that it is the same at Pfizer, Glaxo, Sanofi-Aventis and Wyeth and every other major company," Hirsch said.

"To put major information out about particularly early-phase trials, their design and how they are being done...would be tantamount to disclosure of the regulatory strategy, the timing and just enormous disclosure of critical information that...[would] prevent the ability of companies to gain an appropriate return on their investment."

Merck is particularly concerned about the potential that a group of major medical journals will require registry of trials at inception as a condition for publication ( ¹ Also see "Medical Journals To Propose Making Trial Registry Condition For Publication" - Pink Sheet, 3 September, 2004. ).

Merck's guidelines on publication of clinical research are in line with those of the Pharmaceutical Research & Manufacturers of America, which also stipulate the commitment to publish hypothesis-testing trials.

One of PhRMA's largest members, GlaxoSmithKline, recently signed a settlement with the N.Y. Attorney General agreeing to publish protocols and results for all company-sponsored trials (² Also see "GSK Settles With N.Y.; Company Will Post Past Trial Data By End Of 2005" - Pink Sheet, 26 August, 2004.).

PhRMA is expected to announce plans for an industry-wide registry Sept. 8.

- Adam Eckstein

Merck Defends Right Not To Publish Clinical Trials

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