The increased concern since 1990 about fraud in pharmaceutical industry-sponsored research has been criticised by many people as being a gross overreaction to a minor problem, but the emphasis on fraud occurring in clinical research is a greater concern.
Clinical research is almost at the end of the research and development chain for a pharmaceutical product. Very many important decisions are made much earlier on the basis of one or two critical experiments. Often dosage recommendations for initial clinical work are based on pharmacokinetic data derived from a small number of animals, and often the results are not duplicated. The carcinogenic risk or toxic risk to humans is often extrapolated from one or two pivotal toxicology studies. On the other hand it is very unlikely that key decisions concerning the assessment of risk or dosage would be based on a single clinical comparative trial.
Thus, unreliable data, particularly in relation to toxicology or pharmacology, could have much more serious implications than fraud occurring in a single phase III or phase IV clinical study. Companies should therefore be equally vigilant with regard to preclinical experiments as to clinical experiments in humans. Unfortunately, from the general public's perspective, this does not seem to have been the case.
Many of the earlier cases of fraud that have been drawn to the public's attention have been relatively trivial examples occurring in postmarketing surveillance or large scale general practice studies. More recently, however, cases of fraud in earlier phase research have come to public notice. The relative importance of early phase research must commit a company to having the most stringent checks and balances to ensure that all data coming out of early phase research are genuine and validated.
Despite the concern that undue emphasis has been placed on clinical research, as distinct from early phase research, most of the steps that companies are introducing to protect themselves against clinical research fraud are equally applicable to in-house or contract research.
In this chapter I will outline some of the approaches that can be adopted by companies in order to protect themselves against clinical fraud, because that is where most experience has been obtained.
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