Data Monitoring Committees
Data monitoring committees are established by a trial sponsor to assess, 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 the trial.
The primary mandate of a data monitoring committee is to protect patient safety. Clinical trials often run over a long time and the study personnel and participants are blinded as to which treatment each participant received. Study personnel won't be able to tell if a particular treatment is harming the participants - which should make the trial stop early.
Data monitoring committees fill this gap. A data monitoring committee is made up of clinicians and biostatisticians who are independent of the funder, sponsor, and trial. They can unblind participant data to check safety and efficacy, without affecting the blinding in the study. They are also objective, as they have no stake in the trial itself.
The data monitoring committee can recommend stopping a trial early due to:
- Safety: If the studied treatment harms patients and this harm outweighs any benefit from the treatment, then it is not in the best interest of the participants to continue.
- Futility: If it is clearly no difference between the treatment arms halfway through a trial, then there is no value to completing the full trial period.
- Efficacy: In very rare situations, the data may show that a treatment is vastly superior to the alternatives sooner than expected.
CSM members regularly serve on data monitoring committees for trials that are not connected to the University of Oxford.
The NHS offers extensive guidance on the role of the data monitoring committee.