Healthy Skepticism Library item: 523

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Scheifele DW.
Clinical trials and tribulations: a personal view of interacting with pharmaceutical manufacturers.
Clin Invest Med 1997 Jun; 20:(3):188-92

Abstract:

As grants from agencies shrink, universities and academic researchers are pursuing work on clinical trials funded by pharmaceutical manufacturers. The author, an investigator with a nonprofit research cooperative, offers insight and advice on industry-sponsored trials. He finds that the “doorways” to industry research are hidden, as are industry priorities. Researchers with limited experience have trouble “breaking in” and, when they do work on industry-sponsored trials, are usually given the less interesting work at first. Difficulties encountered during industry-sponsored trials include lack of researcher input, unreasonable enrolment requirements, delays by the sponsor and quashing of publication of unfavourable results. On the positive side, a good experience can include stimulating research, with the researcher playing a substantial role in all phases, an adequate budget, rapid turnaround and publication of the results. To succeed in this environment, trialists should have established expertise, technical and managerial abilities, appropriate resources and strong personal attributes; a national or international reputation is an asset. Researchers can benefit from universities’ industry liaison offices and from strong oversight by institutional review boards.

Keywords:
*analysis Canada drug company sponsored research SPONSORSHIP: RESEARCH