Clinical trials : a practical approach by Stuart J. Pocock

By Stuart J. Pocock

This accomplished, unified textual content at the ideas and perform of scientific trials offers a close account of ways to behavior the rigors. It describes the layout, research, and interpretation of scientific trials in a non-technical demeanour and offers a basic point of view on their historic improvement, present prestige, and destiny procedure. positive aspects examples derived from the author's own event.

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Around half of this effort can be attributed to three types of product: anti-infectives, central nervous system agents and cardiovascular drugs. It is difficult to convert such financial costs into numbers of trials and numbers of patients, but certain less-precisely documented facts ,may help. Although there are 149 PMA members, there are between 20 and 30 major US drug companies which are research-intensive. A typical one of these larger companies would have of the order of 20-50 pharmaceutical products currently undergoing clinical trials prior to marketing.

This example indicates the considerable amount of time and effort required to evaluate a new therapy for such chronic conditions as ischaemic heart disease. 3, the collective findings of clinical trials for beta-blockers after myocardial infarction provide another illustration. Past experience leads one to believe that new therapies are unlikely to produce really radical improvements in patient survival so that one is inevitably drawn into large-scale trials designed to detect moderate, but nevertheless important, therapeutic advances.

There are 450 major cancer centres involved and 386 currently active clinical trials accruing around 19 500 patients per annum. In addition, there is considerable local research, usually in smaller trials and phase I and II studies, at each individual cancer centre. Thus, in the American cancer trials programme, particularly as regards chemotherapy, the last 30 years have seen develop the greatest onslaught of randomized controlled trials that has ever occurred in a single disease area. Successes have not been easily come by and 24 there are occasional accusations that such intensive research may sometimes lead to the overzealous recommendations of highly toxic and marginally effective regimes (see Nelson, 1979), but the clear advances in leukemia, lymphomas and breast cancer do much to justify this approach.

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