Unreasonable expectations

The industry, in its constant drive to shorten the development time for new pharmaceuticals, exerts considerable pressure on its research and discovery group. Simple calculations can show that each month's delay in product licence approval, in a major country, can lead to loss of sales revenue of many millions of pounds. In the light of this pressure it is not surprising that there have been cases where short cuts have been taken in the development process. Sometimes these short cuts have led to the fraudulent generation of data.

An investigator, with a proven track record in a fairly simple and straightforward study, is asked by the company to do a second or third study. The new study, however, is a much more complex design, much more stretching scientifically, and requires much more commitment both of time and effort from the investigator. The investigator feels embarrassed to admit that he does not properly understand the study, the company assumes because he has done the earlier study well that he is "a good investigator", and does not take the time adequately to explain what is required of him. This is a recipe for disaster.

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