Clinical trials – a guide for CAB members (page 16)

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  • The Data Safety and Monitoring Board (DSMB) is responsible to monitor a study for any problems with the safety or effectiveness of the medicine being used. It is different from an Ethics Committee because it oversees the study in all of the institutions, hospitals, and/or countries where the study is done. In other words, an Ethics Committee looks at the study data (information collected from participants) only from the institution or country for which they are responsible. The DSMB looks at the data collected for the study in total (from all hospitals, institutions, countries where the study is being conducted).
  • The DSMB checks all available study data at specific times during the clinical trial—for example, at one month, 3 months, and 6 months.
  • The DSMB monitors safety. For example: Are there more side effects or problems than expected in any of the study groups? Have there been any unexpected serious side effects? If so, as mentioned earlier, the study may be stopped or changed to protect participants.
  • The DSMB also monitors effectiveness (how well the medicine is working). For example: If a study is comparing two medicines, and it becomes clear from the data collected that one medicine is not working at all, and the other medicine is working well, the DSMB would stop the study and offer all participants the more effective medicine.
Published: August 31, 2008
Last edited: January 25, 2011