Question

You are on the DSMB of a double-blind clinical trial of a two-arm pharmaceutical intervention study with a time-to-event outcome. A DSMB meeting will occur after the first third of the participants are enrolled. Briefly describe two data summaries you would expect to be reported on in the open session of a DSMB meeting, and give a brief rationale for why the DSMB would want to see those summaries

Answer 1

Summary of DSMB reports
1.The dramatic withdrawal of rofecixib by Merck on 30 september 2004 was the result of a recommended by a data safety monitoring Board (DSMB) TO TERMINATE A PLACEBO-CONTROLLED STUDY OF THIS DRUG IN THE PREVENTION OF COLONIC POLYP ,BECAUSE OF A STATISTICALLY SIGNIFICANT INCREASE IN ADVERSE CARDIOVASCULAR OUTCOMES.
-Another drug trail terminated around that time(17 December 2004) was by Pfizer,of celecoxib in the prevention of colonic polyps,because it showed statistically significant evidence for increased cardiovascular event rates.

2.In 2002, a large,multicentre randomized controlled trail testing hormone replacement therapy in healthy,postmenopausal women was terminated because it was felt that the evidence already generated from the trial should be made available to the current and future trial participants to help them make decisions about future use of hormone replacement therapy.