Study finds some medical schools cede substantial control of clinical trials

Study finds some medical schools cede substantial control of clinical trials

Academic medical centers tolerate widely differing levels of drug-company control of the clinical trials they conduct, according to a study published in The New England Journal of Medicine May 26. The researchers conducting the study found no consensus among researchers at academic health centers on significant issues involving control of data, authorship, and publication rights.

The authors suggest that such variance may allow or encourage drug companies to place grants only with researchers at the medical schools that are most willing to cede control over data and publishing—in other words, to shop around for the academic investigators with the least-stringent policies. According to the study, industry-financed research makes up about 70% of all clinical trials.

To conduct the study, the research team sent questionnaires to research administrators at the 122 accredited medical schools in the United States; 107 responded, for a response rate approaching 90%. A member of the Harvard School of Public Health led the research effort.

Almost all of the respondents said they would allow a sponsor to review manuscripts before publication, and almost none said they would allow a drug company to decide that the results should not be published. However, responses varied widely on other issues.

Less than half of respondents said they would prohibit an industry sponsor from analyzing and writing up the research results for publication with the academic investigators only suggesting revisions. Half said they would allow this practice, and a few were not sure if they would allow it or not. Responses of "yes," "no," and "not sure" were divided almost evenly on whether they would allow a sponsor to store the data, releasing portions to the investigators.

Most of the institutions (82%) had experienced conflict with an industry sponsor of a clinical trial within the past five years, often over payment. More than two-thirds (69%) said that competition for sponsors had put pressure on them to compromise their standards.

Gregory D. Curfman, NEJM executive editor of NEJM, called the results very disappointing and said that little improvement had been made since 2002 when the journal published a similar study, conducted by researchers at Duke University. He argued that an important step would be for medical schools to join forces and promote greater academic control of agreements with drug companies.

The article, "Academic Medical Centers' Standards for Clinical-Trial Agreements With Industry," is available to The New England Journal of Medicine subscribers on its Web site at content.nejm.org/.

Source: Chronicle of Higher Education, May 27, 2005