The Biostatistician is a member of the Sponsor-Investigator’s central coordinating trial team and has an important role throughout the life cycle of a clinical trial.
In the planning stage, statistical input is essential to ensure that the research question is answerable, the study design and plan for data collection are appropriate to address the research question, the sample is adequate and the analysis methods are appropriate.
Before the start of the trial, an independent Biostatistician should generate the random allocation of study participants to the trial interventions.
During the conduct of the trial, issues regularly arise where statistical input is essential to maintain the integrity of the trial, for example, data collection and cleaning, participant withdrawal, and protocol violations. The Biostatistician, together with other members of the study team, should regularly review these issues.
Also, where applicable, Biostatisticians are involved in Data and Safety Monitoring Boards (DSMB), sometimes called the Data and Safety Monitoring Committee. In addition to the trial statistician, a Biostatistician (who is independent from the study, ie not the trial statistician) serves on the board or committee. The trial statistician oversees preparing statistical reports for the board or committee.
The Biostatistician plays a crucial role in the analysis of the study data.
The Biostatistician should develop a statistical analysis plan to provide the details of how the study data will be analysed. The plan must be written before the database is locked for analysis and the ‘breaking of the blind’. Breaking of the blind is the act of revealing the random allocation of all study participants.
Finally, the Biostatistician contributes to the interpretation and reporting of the study results.
Budget for statistics
It is important to ensure that there is appropriate funding available to cover the cost of Biostatistical support for a trial. Guidance on how to budget for a Biostatistician as part of a Sponsor-Investigator’s central coordinating trial team is available at Australian Clinical Trials Alliance: Grant Advice for Trial Statisticians.
Include the Biostatistician in discussion when putting the budget together, as the required budget for Biostatistical support will depend on the scope and complexity of the study.
Australian Clinical Trials Alliance: Grant Advice for Trial Statisticians
US Food & Drug Administration: E9 Statistical Principles for Clinical Trials