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LECTURE 26 2011 - Assorted Issues in the Closeout of a...

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Assorted Issues in the Closeout of a Trial
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Closeout (def.) The process of separating a patient from the trial after completion of required follow-up. Meinert C, Clinical Trials. Design, Conduct, and Analysis
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Planned Closeout Have some time to plan! Choice of closing date Plan for verifying event status as of closing date Final review/changes to data analysis plan Plan for locking database Plan for continued provision of treatment Communications plan Patients Investigators (e.g., executive summary and slide set) Sponsors (possibly FDA) IRBs and ethics committees Press release, fact sheets and Q&As Presentation and publication
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Case Example Coordinated Ending of Two Trials: ESPRIT and SILCAAT, Closing Date: November 15, 2008; planned number of primary events = 320
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“The Board approves the investigators’ plans for ending the trial when the projected event total will be very close to the target number, probably around the end of 2008.” Recommendations from the November 2007 DSMB meeting: ESPRIT
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“The Board finds that the investigators’ plans to end this trial concurrently with the end of the ESPRIT trial are scientifically sound and practically sensible. While the trial cannot meet it original design of 300 primary endpoints, the Board believes that the study team’s projections of the number of additional events that will occur through 2008 are reasonable. Furthermore, these data will be valuable to the overall power of this trial, both on its own and for comparison to the results of ESPRIT.” Recommendations from the November 2007 DSMB meeting: SILCAAT
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When will ESPRIT reach the required 320 events?
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