Behind closed doors: the data monitoring board in randomized clinical trials.

Abstract:

:Many randomized clinical trials include a data and safety monitoring board (DSMB) that is responsible for reviewing accruing data, monitoring performance of the trial, assuring safety of the participants in the trial, and assessing the efficacy of treatment. The DSMB often makes recommendations about continuation of the trial or alteration of the protocol. Although such boards are very influential in both the conduct and interpretation of randomized clinical trials, there is no standard mode in which DSMBs operate nor do they routinely report publicly about their deliberations. This paper describes the composition of DSMBs as well as their functions. It concludes with a series of questions that needs to be addressed to ensure that the DSMBs operate effectively.

journal_name

Stat Med

journal_title

Statistics in medicine

authors

Wittes J

doi

10.1002/sim.4780120504

subject

Has Abstract

pub_date

1993-03-01 00:00:00

pages

419-24

issue

5-6

eissn

0277-6715

issn

1097-0258

journal_volume

12

pub_type

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