Academic medical centers differ in clinical trial standards

AORN Journal,  July, 2005  

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A survey of academic medical centers found that some have more stringent standards than others regarding the aspects of clinical trials that industry sponsors are permitted to control, according to a Nay 25, 2005, news release from the Harvard School of Public Hearth, Boston. Approximately 70% of clinical medication trials in the United States are funded by industry sponsors.

Surveys that included questions about 17 specific contractual provisions restricting investigators' control over clinical trials were sent to 122 accredited US medical schools. A total of 107 medical school administrators responded, and more than half of the respondents handle 100 or more clinical trial agreements per year.

Researchers found some areas of consensus. For example,

* 89% of respondents said they would not permit an industry sponsor to revise a manuscript written by an academic investigator;

* 93% believe it is unacceptable to arrow industry sponsors to decide that research results should not be published;

* 96% would allow industry sponsors to review manuscripts for a limited time (eg, 60 days) before publication; and

* 66% would Let sponsors prohibit investigators from discussing ongoing clinical trials, but the same percentage would disallow this prohibition after the trial concluded.

On other issues, there was a wide divergence in medical schools' standards. For example,

* 50% of respondents would arrow sponsors to draft manuscripts reporting research results and limit the rote of the academic investigators to suggesting revisions, and 40% would not;

* 24% would allow industry sponsors to insert their own statistical analyses into manuscripts, 47% would not, and 29% were not sure; and

* 41% would allow sponsors to prohibit investigators from sharing data with third parties after the trim was over--a practice some scientists view as important for verifying research findings.

The Level of control sponsors exercise over clinical research has become a subject of concern because of recent allegations that pharmaceutical companies did not disclose study results about the safety risks of certain medications in a timely fashion. Variations in standards raise a concern that industry sponsors could channel their studies to the more permissive institutions. According to the researchers, partnerships between industry sponsors and medical schools are essential to the advancement of medical science, but these relationships need to be managed carefully to balance the sponsors' needs against the investigators' academic freedom and the public's well-being.

Survey of Academic Medical Centers' Agreements With Industry Finds Differing Standards for Control of Clinical Trial Results (news release, Boston: Harvard School of Public Health, May 25, 2005) http://www.hsph.harvard .edu/press/reLeases/pressO5252005.htmt (accessed 26 May 2005).

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