The DSMB is an independent panel of experts established by NIAID and charged with the responsibility of monitoring the progress of trials, the safety of participants, and the efficacy of treatments being tested. The DSMB also makes recommendations to NIAID concerning continuation, termination or modification of the studies based on observed beneficial or adverse effects of any of the interventions under study. This panel is funded separately by NIAID.
Researchers- ideally independent of the trials they monitor- who periodically review data from blinded, placebo-controlled trials. A DSMB can stop a trial if toxicities are found or if treatment is proved beneficial. See also independent data-monitoring committee.
A group of independent experts that review the research data periodically to ensure the safety of the participants
An independent committee whose membership includes, at minimum, a statistician and a clinical expert in the area being studied. Responsibilities of the DSMB are to: ensure that risks associated with participation are minimized to the extent possible, ensure the integrity of the data, and stop a trial either if safety concerns arise or as soon as its objectives have been met.
An external, independent, multi-disciplinary group of experts who monitor a clinical trial's progress as well as accumulating data for the emergence of any early benefit or harm. The DSMB usually recommends continuation, but may recommend alteration or early termination in which case there is immediate reporting of findings.
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.
A committee of scientists, physicians, statisticians, and others that collects and analyzes data during the course of a clinical trial to monitor for adverse effects and other trends (such as an indication that one treatment is significantly better than another, particularly when one arm of the trial involves a placebo control) that would warrant modification or termination of the trial or notification of participants about new information that might affect their willingness to continue in the trial.
A committee of independent clinical research experts who review data while a clinical efficacy trial is in progress to ensure that participants are not exposed to undue risk. Also monitors the trial for differences in efficacy between those receiving the drug and those receiving placebos.
An independent committee that collects and analyzes data during the course of a clinical trial to monitor for adverse effects and other trends (such as an indication that one treatment is significantly better than another, that would warrant modification or termination of the trial, or notification of subjects about new information that might affect their willingness to continue in the trial. DSMBs are required by NIH for all Phase III clinical trials but may also be appropriate for Phase I and Phase II clinical trials if the studies have multiple clinical sites, are blinded (masked), or employ particularly high-risk interventions or vulnerable populations.
Independent committee that reviews clinical trial progress and safety and advises NIAID whether to continue, modify, or terminate a trial. One of several types of clinical trial monitoring options. Go to our Data and Safety Monitoring Boards SOP.
1. A standing committee responsible for periodically reviewing accumulated data for evidence of adverse or beneficial treatment effects during the trial and for initiating recommendations for modification of a study treatment, including termination of the treatment when appropriate. 2. One of the key committees in the organizational structure of a multicenter trial. Usually composed primarily, if not exclusively, of individuals not directly involved in patient care or data collection in the trial.