JSM 2004 - Toronto

Abstract #300039

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Activity Number: 257
Type: Invited
Date/Time: Tuesday, August 10, 2004 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #300039
Title: Data Monitoring Committees--an NIH Approach
Author(s): Lawrence Friedman*+
Companies: National Heart, Lung, and Blood Institute
Address: Bldg. 31, Room 5A47, Bethesda, MD, 20892-2490,
Keywords:
Abstract:

NIH has used data monitoring committees (DMCs) since the mid-1960s. At first they were only used for selected clinical trials and varied considerably in how they were constituted and functioned. Over time, their use broadened, and today they are used for all late-phase trials. Many early phase trials, such as those with particularly invasive or dangerous interventions or vulnerable populations, also have DMCs. Even those NIH trials without DMCs must have data monitoring plans. A DMC's primary responsibility is to make sure that trial participants are not unnecessarily harmed. Secondarily, it ensures the trial's scientific integrity. DMCs usually monitor data from single trials. Exceptions are networks, where they monitor all studies conducted by the network, and trials done at NIH, where DMCs will monitor many trials in particular scientific areas. Members of DMCs are independent of investigators and sponsoring NIH institutes. They should have no major financial or other conflicts of interest. Members have expertise in the field under investigation, biostatistics and, often, bioethics or patient advocacy. Operational procedures of NIH DMCs will be described.

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Revised March 2004