Just sum reading on the role of the DSMB.
What is a DSMB and what is its role?A DSMB is a multidisciplinary group established by the trial sponsor to review, at regular intervals, accumulating trial data, in order to monitor the progress of a clinical trial.3 Their role is to provide advice on safety and/or trial conduct issues by making recommendations to the sponsor, or the Trial Steering Committee (TSC), on whether to continue, modify or stop4 a trial for safety or ethical reasons
[1]. DSMBs go by a variety of names including Data Monitoring Committee (DMC) and Data Monitoring and Ethics Committee (DMEC). These entities will be referred to as DSMBs within this document.While investigators and sponsors monitor the day‐to‐day conduct of the trial, DSMBs make recommendations concerning the overall conduct of the trial. The DSMB’s access to unblinded and often comparative data enables it to undertake a more comprehensive and integrated review
[2]. DSMBs play an important role in:• safeguarding the interests of study participants• ensuring that definitive and valid results are produced which will reliably inform the future treatment of patients• enhancing the credibility of the trial.
Table 1: Areas where risks may be mitigated by the presence of a DSMB5RiskDSMB roleHow risk is mitigatedParticipant interestsData validityIdentify, through regular monitoring, serious emerging safety concerns as rapidly as possible, so as to minimise the time that participants may be placed at excess risk of harm.Maintain confidentiality of unblinded interim results and provide an objective and unbiased assessment of those results.Contribute to the successful completion of a trial by periodically reviewing accumulating trial data, toinform trial conduct decisions.Through monitoring of interim, unblinded, comparative data, (available only to the DSMB) the DSMB is able to develop a clear picture of the emerging balance of risks and benefits.By keeping the sponsors and trial investigators blinded to emerging trends that may impact on their ongoing decision making, the risk of bias is substantially diminished.
By reviewing aspects of trial conduct (e.g. recruitment rates, protocol compliance, the accuracy and completeness of data capture, including missing data and rates of loss to follow-up), to identify problems and recommend action.
Sponsors may delegate their functions to third parties (e.g. a Contract Research Organisation, Coordinating Principal Investigator or coordinating centre). The term sponsor in this document means sponsor or their delegate.4 Some trials plan for a series of interim analyses of the accumulating trial data, with stopping rules based on the findings.
The DSMB may recommend stopping a trial based on:Safety: If the trial treatment harms participants, and this harm outweighs any benefit from the treatment, then the trial may be stopped to prevent participants from continuing to receive a treatment that already appears to be unsafe.
Efficacy: In rare situations, the data may show that a treatment is vastly superior to the alternatives sooner than expected and stopping may allow a successful treatment to become generally available as soon as sufficient evidence of its advantages has been collected.
Futility: If there is clearly no difference between the treatment arms part way through the trial and there is sufficient data to indicate that, even if the trial were to continue to its conclusion, it is extremely unlikely that the new treatment would show a statistically significant benefit.
Blinding the sponsor/investigator to interim outcome data reduces the risk that they will be influenced by any interim data indicating emerging trends that could be attributable to chance and could lead to false conclusions. Blinding of the sponsor/investigator to interim outcome data also preserves their ability to make certain modifications to a trial in response to new external information without introducing bias
[4].Data Safety Monitoring Boards (DSMBs) 3RiskDSMB roleHow risk is mitigatedTrial credibilityEnhance trial credibility particularly:Trials designed to provide definitive information about effectiveness and/ or safety of an intervention and, therefore, have significant public health impact.Trials where there is a significant perception (fair or not) that financial or professional goals might unduly influence the sponsor/investigator.By involving experts that are widely recognised for their expertise in the area being studied, the uptake/acceptance of trial results by the medical community may be enhanced [2].Through enhancement of objectivity. The perception of a conflict of interest could harm the ultimate credibility of a trial.Each increment of independence will add to perceived objectivity, with a fully independent DSMB maximizing that perception [3].
ACW has managed to undergo two reviews from the DSMB recommending continuation of trial without change. Wishing my life away for the final results.
(20min delay)