Example

 

"A steering committee is responsible for the design, integrity, and progress of the trial. The steering committee is also tasked with implementing any potential protocol modifications, including those that may be recommended by the DMC [data monitoring committee]. The steering committee comprises staff of the UMC [University Medical Centre] Groningen and lead investigators of all participating study centers. An independent DMC has been appointed to carry out the safety-related tasks described above. The DMC consists of three internist-nephrologists and an epidemiologist. All DMC members declared no competing interests. The DMC charter is available as Supplementary material. An academic contract research organization will monitor the progress of the study and the quality of study data. Additionally, a patient advisory committee consisting of several patients … was assembled to provide input to the steering committee from a patient perspective.

 

Figure 3 shows the structure of the study organization and the relationships between its components [53].

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Explanation

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A randomised trial will often include various committees or groups to facilitate trial coordination and conduct, e.g., a Trial Management Group (day-to-day trial conduct) and a Trial Steering Committee (executive decisions) [54, 55]. 

 

Information on the types, conduct, and membership of such committees helps to ensure that roles and responsibilities are clearly understood at the trial onset and facilitates communication from external parties regarding the trial. It also enables readers to understand the mandate and expertise of those responsible for overseeing participant safety, trial design, database integrity, and study conduct.

 

The complexity of a trial, and the need for a clear division of responsibilities and a transparent organisational structure, increase with the number of included sites and participants. Of particular importance is the trial steering committee and its independence from the trial sponsor or funder. The data monitoring committee is also central and is described in more detail in Item 28a on trial monitoring. Reviews of two samples of 108 and 292 trial protocols from 2016 found that 98% and 92% respectively reported the steering committee membership and roles [9, 10].

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The protocol should outline the general membership of the various committees or groups involved in trial coordination and conduct; describe the roles and responsibilities of each, including their relationship to the trial sponsor or funder; and (when known) identify the chairs and members of each committee.

 

Summary of key elements to address

For each trial committee:

• Roles and responsibilities

• Relationship to trial sponsor and funders

• Outline of membership (e.g., clinician, biostatistician, patient)

• Names of Chairs and members, when known

 

Examples of committees include:

• Trial Steering Committee (executive decisions)

• Trial Management Group (day-to-day trial conduct)

• Data Monitoring Committee (review of accumulating data)

• Endpoint adjudication committee

• Data management team

• Other individuals or groups overseeing the trial​