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Healthy Skepticism Library item: 1230

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

Cleophas GC, Cleophas TJ.
Clinical trials in jeopardy.
Int J Clin Pharmacol Ther 2003 Feb; 41:(2):51-5


Abstract:

BACKGROUND: The controlled clinical trial, the gold standard for clinical research, is in jeopardy. The pharmaceutical industry is rapidly expanding its command over clinical trials but scientific rigor requires independence and objectivity. Safeguarding such criteria is hard because industrial sponsors, benefit directly from favorable results and are virtually in complete control. OBJECTIVE: To review flawed procedures jeopardizing the credibility of trials and to look for possible solutions to the conflict between sponsored industry and scientific independence. RESULTS: Flawed procedures jeopardizing current clinical trials can be listed as follows. Industries, at least in Europe, are allowed to choose their own independent protocol review board prior for approval. The independent protocol review board approves protocols even when the research is beyond the scope of its expertise. Health institutions hosting multicenter trials are requested to refrain from scientific or ethic assessment of the trial. Trial monitors are often employees of industry. Data control is predominantly in the hands of the sponsor. Interim analyses are rarely performed by independent groups. The scientific committee of the trial consists largely of prominent but otherwise uninvolved physicians attached to the study. The analysis and report of the trial is generally provided by clinical associates of the pharmaceutical companies and, after a brief review, co-signed by prominent physicians attached to the study. POSSIBLE SOLUTIONS: Possible solutions to the conflict between sponsored industry and scientific independence could include the following. Surveillance by independent observers during each stage of the trial is desirable. In contrast, tight control of study data, analysis, and interpretation by the commercial sponsor is undesirable. If, instead, the pharmaceutical industry allows the profession to more actively participate in different stages of the trial, scientific research will be better served, reasonable biological questions will be better answered, and, because the profession will be more convinced of the objective character of the research, it will not be counterproductive to the sales.

Keywords:
Conflict of Interest Drug Industry* Ethics Committees, Research*/organization & administration Ethics Committees, Research*/standards Humans Randomized Controlled Trials*/ethics Randomized Controlled Trials*/trends

 

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Cases of wilful misrepresentation are a rarity in medical advertising. For every advertisement in which nonexistent doctors are called on to testify or deliberately irrelevant references are bunched up in [fine print], you will find a hundred or more whose greatest offenses are unquestioning enthusiasm and the skill to communicate it.

The best defence the physician can muster against this kind of advertising is a healthy skepticism and a willingness, not always apparent in the past, to do his homework. He must cultivate a flair for spotting the logical loophole, the invalid clinical trial, the unreliable or meaningless testimonial, the unneeded improvement and the unlikely claim. Above all, he must develop greater resistance to the lure of the fashionable and the new.
- Pierre R. Garai (advertising executive) 1963