Download Clinical Trials by Stuart J. Pocock(auth.) PDF

By Stuart J. Pocock(auth.)

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G. lung cancer, where the value of chemotherapy has remained very limited. So far I have tended to look at cancer trials in terms of specific improvements in treatment. Of course, if promising treatments do not exist then no progress can be made. However, one vital element in US cancer trial cooperative groups such as ECOG has been the consistent development of scientifically and statistically designed trials in a well-organized framework. In 1982 ECOG has 26 member institutions (which include 164 affiliate hospitals attached to such institutions) and 44 active studies accruing around 2000 new patients per annum.

However, in reality one needs to draw a clear distinction between such marketing operations and the research and development activities of a company. On the whole, my experience of premarketing clinical trials (phases I- III) in the pharmaceutical industry leaves me of the opinion that such research is genera1\y carried out in an objective manner. Particularly, standards have improved in the last 15 years as a direct result of stricter control by national regulatory bodies such as the US Food and Drug Administration.

However, the quality of such forms and the reliability of subsequent data processing are major requirements for the successful conduct of a clinical trial. If possible the protocol can refer to certain potential protocol deviations: it is better to anticipate problems rather than simply to wait for them to occur. For instance, in drug trials one can introduce checks on patient compliance with the treatment schedule. Also, one can specify appropriate dose modifications if side-effects are to be expected in some patients.

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