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Quality Control Management

Randomised Controlled Clinical Trials by Christopher J. Bulpitt (auth.)

By Christopher J. Bulpitt (auth.)

After thirteen years there are new parts to debate and newer trials to be integrated. stable medical perform; assessment of caliber of lifestyles; size of the benefit:risk comparability; decision of price- effectiveness and price software; preventing ideas for trials; meta-analysis and subgroup research are all new sections. The references are improved from 305 to 512 and comprise the new advances in trial layout, corresponding to the n-of-1 trials and megatrials, and updated examples to demonstrate the issues made within the 20 chapters.

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Sample text

The 43 of one study decreed that "clinical investigators and their spouses and dependents should not buy, sell, or hold stock or stock options in any company providing or distributing medicines under study" [72]. organisers CONCLUSIONS This chapter reviews the ethical requirements in the design and conduct of clinical trials. Declarations of ethical principles have been reviewed and the place of research ethical committees considered. Emphasis was placed on the importance of obtaining informed written consent and a distinction has been drawn between trials of possible benefit to the participant and trials involving volunteers who cannot expect an improvement in their health from participating in the trial.

I would be reluctant to take part in a trial where toxicity may be a disadvantage not counteracted by important gains from therapy. THE INFLUENCE OF FINANCIAL REWARDS The financial rewards to the investigator or the volunteer must not be excessive. Both parties must avoid unreasonable risks and risk-taking would be increased for large financial gains. Waldron and Cookson [67] have pointed out that the name of a trial sponsor may not be known (the trial being conducted through a contract research organization), and that the results of the research are often not published.

When should standard parallel groups design be employed? When treatment is curative If the trial is to test a curative treatment for an illness, the cross-over design cannot be employed. There is no point in a cured patient continuing with further treatments. When the duration of treatment has to be long If the effect of a drug has to be determined after, say five years, a cross-over trial may take too long since the duration of the trial is ten years with two treatments and 20 years with four.

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