Drug trial agreements called into question

Most medical institutions no longer allow sponsoring drug companies to suppress negative clinical trial results, but many do permit sponsors to influence research publication in other ways, according to a new study in the May 26 New England Journal of Medicine.

Michelle Mello, PhD, lead author of "Academic Medical Centers' Standards for Clinical-Trial Agreements with Industry" surveyed U.S. medical institutions about their standards for clinical trial agreements. She was encouraged to find that most refuse to let sponsors block publication of negative results. However, she found many make other compromises that could color what research results become public.

The issue of censorship of clinical trial results most recently came to the forefront with the withdrawal of COX-2 inhibitor painkillers and the release of negative data tied to antidepressant use among children. Dr. Mello sees her study as a tool to aid the medical profession as it seeks reform.

"I'm hoping that this will get people in the medical community talking to one another about these gray areas, so there's less chance of drug companies shopping among medical schools or playing them off one another," Dr. Mello said.

Such behavior is a real danger, she said, because drug companies fund 70% of the clinical drug trials in the United States, and medical schools are getting an ever-decreasing slice of this pie, thanks to the emergence of corporate research organizations. Without standards on data ownership and publication rights, the least scrupulous could win the most funding, she said.

Her survey found 60% of administrators responsible for negotiating clinical study agreements felt there was pressure in the market for research funding, including pressure to compromise on the language of research agreements. Some 93% said it was impermissible to allow sponsors to not publish research results and 89% said it was wrong to permit the industry sponsor to revise an investigator's manuscript.

However, 96% would accept a provision permitting the sponsor to review manuscripts for a limited time before publication. Some 80% would allow the sponsor to own the research data, 68% said they would accept a provision barring investigators from altering the study design, and 15% indicated they would allow preventing investigators in a multicenter trial from publishing independently.

Administrators were nearly evenly split between approval, disapproval and uncertainty regarding whether the industry sponsor could have custody of the data and only release portions of it to investigators.