Data and Safety Monitoring Board (DSMB)
A Data and Safety Monitoring Board (DSMB) is an independent and impartial Committee that is responsible for overseeing an ongoing clinical trials and reviewing clinical trial data.
- AKA: Data Monitoring Committee (DMC), Independent Data Monitoring Committee (IDMC).
- Example(s):
- Counter-Example(s):
- See: Clinical Trial Protocol, Decentralized Clinical Trial, Clinical Trial Design, Clinical Trial Management System, Clinical Data Management System, Good Clinical Practice, Clinical Trial Sponsor.
References
2021a
- (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/Data_monitoring_committee Retrieved:2021-12-11.
- A data monitoring committee (DMC) – sometimes called a data and safety monitoring board (DSMB) – is an independent group of experts who monitor patient safety and treatment efficacy data while a clinical trial is ongoing.
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Many randomized clinical trials are double blind – no one involved with the trial knows what treatment is to be given to each trial participant. Blinding includes the participant, their doctor, and even the study personnel at the company or organization sponsoring the trial. Blinding is breached and true assignments disclosed only after the trial database is finalized.
Clinical trials may test an unknown procedure or may continue for years, and there is justifiable concern about enrolling participants and exposing them to an unproven treatment without ongoing oversight of the preliminary results. The DMC is a group (typically 3 to 7 members) who are independent of the entity conducting the trial. At least one DMC member will be a statistician. Clinicians knowledgeable about the disease indication should be represented, as well as clinicians knowledgeable in the fields of any major suspected safety effects. Ethicists or representatives from a patient advocacy group may be included, particularly for research involving vulnerable populations. The DMC will convene at predetermined intervals (depending on the type of study) to review unblinded results. The DMC has the power to recommend continuation or termination of the study based on the evaluation of these results. There are typically three reasons a DMC might recommend termination of the study: safety concerns, outstanding benefit, and futility.
- A data monitoring committee (DMC) – sometimes called a data and safety monitoring board (DSMB) – is an independent group of experts who monitor patient safety and treatment efficacy data while a clinical trial is ongoing.
2021b
- (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/Glossary_of_clinical_research#D Retrieved:2021-12-11.
- Data and Safety Monitoring Board or Independent Data Monitoring Committee
- DSMB. An impartial group that oversees a clinical trial and reviews the results to see if they are acceptable. This group determines if the trial should be changed or closed. Also called DSMB. (NCI)
- An independent committee, composed of community representatives and clinical research experts, that reviews data while a clinical trial is in progress to ensure that participants are not exposed to undue risk. A DSMB may recommend that a trial be stopped if there are safety concerns or if the trial objectives have been achieved. (NLM)
- An independent data monitoring committee that may be established by the sponsor to assess at intervals the progress of a clinical trial, the safety data, and the critical efficacy endpoints, and to recommend to the sponsor whether to continue, modify, or stop a trial. (ICH E6 and ICH E9)
- Data and Safety Monitoring Board or Independent Data Monitoring Committee
2006
- (FDA, 2006) ⇒ U.S. Department of Health and Human Services Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), and Center for Devices and Radiological Health (CDRH) (2006). "Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees". OMB Control No. 0910-0581.
- QUOTE: A clinical trial DMC is a group of individuals with pertinent expertise that reviews on a regular basis accumulating data from one or more ongoing clinical trials. The DMC advises the sponsor regarding the continuing safety of trial subjects and those yet to be recruited to the trial, as well as the continuing validity and scientific merit of the trial. When a single DMC is responsible for monitoring multiple trials, the considerations for establishment and operation of the DMC are generally similar to those for a DMC monitoring a single trial, but the logistics may be more complex. For example, multiple conflict of interest determinations may be needed for each DMC member.