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Download Data Monitoring in Clinical Trials: A Case Studies Approach by David L. DeMets (Editor), Curt D. Furberg (Editor), Lawrence PDF

By David L. DeMets (Editor), Curt D. Furberg (Editor), Lawrence M. Friedman (Editor)

From the authors of "Fundamentals of medical Trials" which has bought over 15,000 copies around the globe considering the fact that its e-book in 1998. No festival but because the textual content doesn't concentrate on easy methods to do medical trials yet on very particular occasions that may be encountered in the course of the approach.

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Sample text

Furberg Lawrence M. ”These examples of issues faced during the monitoring of clinical trials illustrate both how the issues were addressed and how they might have been handled better. Many of these lessons learned have common themes, whereas others are specific to the particular trial. This chapter summarizes the more common lessons in eleven major areas. The division into the eleven areas is somewhat arbitrary; there are clear overlaps among them, and many of the lessons fall into more than one area.

The lack of certainty is one reason that some monitoring boundaries require very extreme differences early in a trial. In addition, as seen in several of the case studies, early trends, even though real, might be reversed by longer follow-up. The short-term effects of interventions might not be sustained in the long-term. But monitoring committees need to be sensitive to putting study participants at risk longer than they need to. If a treatment is truly believed to be beneficial, even in the short-term, those in the control group deserve to have access to it.

Requiring such a strong result, of course, would eliminate a rationale for using a composite outcome. Second, for the component analyses, should the significance level be adjusted for multiple comparisons? Third, is it fair, during the design of the trial, to exclude from a composite outcome individual outcomes that are highly likely to trend in the wrong direction? Even if such an outcome is not officially part of the original composite outcome, monitoring committees should look at the data from all relevant outcomes, and may combine them with the composite to obtain a clearer picture of the overall benefit/harm balance.

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