Data monitoring boards in the pharmaceutical industry.
This paper describes the characteristics and responsibilities of data monitoring boards (DMBs) employed in clinical trials sponsored by pharmaceutical firms. These DMBs are compared with DMBs in clinical trials sponsored by the National Institutes of Health (NIH). All trials discussed are assumed to be phase III pre-market clinical trials. It is seen that DMBs in pharmaceutical industry trials have more limited responsibilities than DMBs in NIH clinical trials. Pharmaceutical industry DMBs are employed to add credibility to trials by certifying critical clinical trial processes such as patient evaluability, interim analyses, evaluation of efficacy endpoints, and safety monitoring. An example of a pharmaceutical industry DMB's charter and operations is presented for a clinical trial for the prevention of stress ulcers. The specific problems encountered when a pharmaceutical industry clinical trial is conducted by NIH under the auspices of an NIH-appointed DMB are discussed. New uses for DMBs in the pharmaceutical industry are introduced and future trends in the industry with respect to DMBs are examined.
Herson
J
J
Applied Logic Associates, Inc., Houston, Texas 77005.
D002986:Clinical Trials as Topic / Q000592:standards*; D004345:Drug Industry; D006801:Humans; D009316:National Institutes of Health (U.S.); D011367:Professional Staff Committees; D013223:Statistics as Topic; D014481:United States