By David L. DeMets (Editor), Curt D. Furberg (Editor), Lawrence M. Friedman (Editor)
From the authors of "Fundamentals of medical Trials" which has offered over 15,000 copies worldwide considering its booklet in 1998. No festival but because the textual content doesn't concentrate on how you can do medical trials yet on very particular occasions that may be encountered in the course of the procedure.
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Additional resources for Data Monitoring in Clinical Trials: A Case Studies Approach
Second, members must be free of conﬂicts in order to make independent, unbiased recommendations. This means that monitoring committee members should not be employees of the sponsoring company or a competitor, or of the sponsoring institute, and should not be involved in recruiting or interacting with trial participants, or be part of the data management team. While committee members must be quite familiar with the protocol and trial design, they must remain sufﬁciently independent that their discussion is not inﬂuenced by any intellectual investment in the protocol.
First, is the proper interpretation that the two interventions in LIFE and PROVE IT reduce the risk of the composite outcomes, or should the claim of beneﬁt be limited to only individual components that are signiﬁcant on their own? 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?
Circulation 47 (Suppl I): I-1–I-79. 2. Organization, review and administration of cooperative studies (Greenberg Report): A report from the Heart Special Project Committee to the National Advisory Heart Council, May 1967. 1988. Control Clin Trials 9:137–148. Monitoring Committees:Why and How 13 3. Canner PL. 1983. Monitoring of the data for evidence of adverse or beneﬁcial effects. ): The Coronary Drug Project. Methods and Lessons of a Multicenter Clinical Trial. Control Clin Trials 4:467–483. 4.
Data Monitoring in Clinical Trials: A Case Studies Approach by David L. DeMets (Editor), Curt D. Furberg (Editor), Lawrence M. Friedman (Editor)