Table 3 Activities undertaken by CTU statisticians in the design and conduct of clinical trials

Co-applicant

• A lead (or principal/senior) statistician who is involved in the grant application

• A TS who is involved in the grant application

Trial oversight/reports^a

• Attends TMGs, TSCs and DMCs as appropriate

• Assists with report writing for trial management meetings and oversight committees (TSC and DMC)

Assists with trial processes^a

• E.g. generating randomisation lists, dummy treatment allocations, data monitoring, data cleaning for example for missing data, data completion rates, etc.

• Assist in the development and quality control (QC) of the clinical trial database and/or randomisation system

• Level of engagement dependent on whether blinded or not

Assists in writing and reviewing core trial documents^a

• E.g. protocol, risk assessment, CRF, SAP and data management plans

• Assist with QC of core trial documents

Training/supervision

• A senior statistician takes on the oversight role for the TS (blinded or unblinded)

• Provides peer or senior support, guidance and training to other statisticians

Analysis

• Conducts end of study analysis

• Conducts any planned/unplanned interim analysis

• Conducts parallel/double/dual coding of the primary outcome for interim or final analyses

• Often the unblinded statistician will create dummy allocations.

Quality control^a

• Validates/QCs any data prepared for reports, the final analysis or any interim analysis that lead to decision making