Study Design and Biostatistics provides research study planning and analytic services, such as study design, sample size estimation, analysis planning, as well as production of statistical reports and graphical displays.
Collaborative information about the CHOP and PENN Study Design and Biostatistics Core can be found on ITMAT
The statistical sections of the protocol should address the following issues:
(1) Design. Summarize the study design and the appropriate terms such as randomized, double blind, crossover, controlled, comparative, and observational.
(2) Hypothesis. Describe the corresponding outcome measures and restate the primary hypothesis from the Specific Aims section in terms of a testable statistical hypothesis (i.e., explain how the outcome measure is expected to be affected by the components of the study design). Similar descriptions regarding secondary hypotheses are welcome.
(3) Statistical Methods. Specify the planned statistical methods that will be used to analyze the primary and secondary outcome measures. Analysis plans must relate to stated specific aims. Include statistical references if a nonstandard method will be used to analyze the primary hypothesis.
(4) Randomization. Specify how any randomization will be done, especially if it involves blocking or stratification to control for possible confounding factors.
(5) Sample size. State the proposed sample size and estimate the statistical power related to testing the primary hypothesis described in (2) above. Outline how you arrived at this estimate in terms of the primary outcome measure. The number of subjects proposed must be adequate to achieve the aims of the study. If for any reason, a power calculation cannot be performed, a detailed explanation is required.
Updated July 2017