Concept and Protocol Design
In the concept and protocol design phase of a research study, the investigator identifies an interesting case series to study or hypothesis to be answered.
The Biostatistics Core team helps investigators make decisions in concept and protocol design such as discussing the number of subjects required, the need of a control population, and if the study should be a case-control or cohort study.
Biostatisticians can also help:
- Evaluate the potential biases due to inclusion and exclusion criteria or case ascertainment
- Discuss and highlight the advantages or disadvantages of various research designs used to address a research question
- Estimate the required number of subjects needed to answer hypotheses with sufficient power or determine the minimal effect difference that can be detected for a predetermined sample size
- Identify appropriate analyses and methodologies that are best suited for the research objectives
- Assist in protocol development for submission to the Institutional Review Board (IRB) or committee review
- Write the statistical methods sections for the protocol