Trial Committees

Various committees are involved in conducting a clinical trial. Some or all of these committees may be required for your trials. Generally in investigator initiated studies, the lead coordinating investigator will arrange for the required committees.

Trial Management/Steering Committee

This committee is chaired by the coordinating investigator. The members may be made up of collaborators on a grant, representatives of different states in multi-institution studies and/or experts in relevant fields involved in a study. A statistician should be part of the management committee. The primary responsibilities of this group may include: design the study and study protocol, maintenance of the quality of study conduct, ongoing monitoring of individual toxicities and adverse events and writing study publications. This group would meet regularly to review the recruitment rates, follow up rates and safety aspects of the study.

If the study is very large or has international members on the TM/SC then a local Trial Executive Committee may be required to attend to local issues and to guide the study in a particular geographical location

Endpoint Assessment/Adjudication Committee

In some cases, an endpoint assessment/adjudication committee may be convened to review important endpoints reported by trial investigators to determine whether the endpoints meet protocol-specified criteria. This committee may review data including laboratory, pathology and/or imaging data, autopsy reports, physical descriptions, and any other data deemed relevant. These committees are useful if an extra layer of objectivity may be required as they will not know the treatment the study participant received. Such committees are particularly valuable when endpoints are subjective and/or require the application of a complex definition, and when the intervention is not delivered in a blinded fashion.

Independent Data and Safety Monitoring Committee

According to the FDA:

All clinical trials require safety monitoring, but not all trials require monitoring by a formal committee that may be external to the trial organizers, sponsors, and investigators. As noted earlier, DMCs have generally been established for large, randomized multisite studies that evaluate treatments intended to prolong life or reduce risk of a major adverse health outcome such as a cardiovascular event or recurrence of cancer.

For more information, click here.

See also the toolkit on ISDMCs.