Clinical Trial Questions

The following questions refer to the following articles:

Goodman SN. Rashoman revisited: two views of monitoring the Women’s Health Initiative trials. Clin Trials 2007;(4)205-206.
Wittes J, Barrett-Connor E, Braunwald E, Chesney M, et al. Monitoring the randomized trials of the Women’s Health Initiative: the experience of the data and safety monitoring board. Clin Trials 2007;(4)218-234.
Anderson GL, Kooperberg C, Geller N, Rossouw JE, et al. Monitoring and reporting of the Women’s Health Initiative randomized hormone therapy trials. Clin Trials 2007;(4)207-217.

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1. In general, what are the 3 courses of action with regard to the conduct of the trial that a DSMB can recommend upon reviewing interim results?

2. Why did the DSMB in collaboration with the CCC choose the global index measure to monitor the outcomes evaluated during the course of the trial? Please explain the ethical as well as methodological issues that guided this decision.

3. After reading the section titled ‘Ending the PERT study’ (Wittes et al., pgs 227 – 228), tell me what YOUR thoughts are about the DSMB’s decision to end the study in May 2002 rather than in November 2001.

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