Biostatisticians are available to CINJ investigators to discuss relevant statistical considerations in the laboratory, population, or clinical study during the concept inception and planning phases. The assigned biostatistician will also write the protocol section on statistical considerations to outline the statistical methods that may be used for the data analyses. All investigators involved in developing clinical trials are encouraged to consult with the Biometrics Shared Resource before submitting an abbreviated or full protocol to the Scientific Review Board. However, if this does not occur, i.e., the investigator chooses to develop the statistical section independently, the shared resource Director, or designee, will carefully review the draft protocol for statistical considerations when it reaches the Scientific Review Board. No protocol advances beyond the Scientific Review Board to the Institutional Review Board without a critical statistical review and a valid statistical section.
Interim analysis is provided, if needed.
For laboratory investigators, these ongoing meetings are at the request of the investigator. For the clinical trials, a more active process of ongoing monitoring has been established. Through participation in the Scientific Review Board, Clinical Research Office, Clinical Investigations Program Meetings, and the Scientific Council, the Biometrics Director learns about the ongoing studies or new CINJ initiatives that might require additional planning for statistical resources. Methods for appropriate data analyses depend on the objective and design of the study. An outline of the data analysis plan should be addressed in the protocol.