Research Design
The ACTSI biostatistics program provides consultation and collaboration in developing NIH grant applications. Program faculty assist investigators in identifying and understanding the scope and nature of their statistical problems, collaborate on study design and framing of hypotheses, assist in planning and budgeting for statistical support, and whenever appropriate, engage specialists among faculty and students of biostatistics as collaborators. Additionally, all investigators’ protocols requesting CRN site support receive a biostatistical consult during the CRN Scientific Advisory Council review. BERD can also match biostatistical trainees with investigators. This program helps investigators receive faster service from enthusiastic and well-trained biostatistical trainees. Biostatistical reviews and consults are critical in improving the validity and chances for success of ACTSI-supported protocols.
Statistical Considerations section should have distinct subsections addressing each of the following issues:
Design: Summarize the study design and the appropriate terms such as randomized, double blind, crossover, controlled, comparative, and observational.
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 welcomed.
Statistical Methods: Specify the planned statistical methods that will be used to analyze the primary and secondary outcome measures. Include statistical references if a nonstandard method will be used to analyze the primary hypothesis.
Randomization: Specify how any randomization will be done, especially if it involves blocking or stratification to control for possible confounding factors. Specify the software package that will be used to implement the randomization plan.
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. If for any reason, a power calculation can not be performed, a detailed explanation is required.
Technical Support: Who will supervise and perform the necessary statistical work? What computing resources will be used? In addition, please note the name/s and affiliation/s of the author/s of the Statistical Considerations section if it was not completed by the DSL staff.
Resources:
The following biostatistical services are available:
- Rapid response to your statistical question via email
- Review of proposals
- Sample size and statistical power calculations
- Study design consultation
- Review of questionnaire/data collection form design statistical analysis
- Pre-submission critique of statistical methods in journal manuscripts
- Statistical genetics, genomics and high-throughput data analysis
Contact Information:
Amita Manatunga, PhD
Professor, Department of Biostatistics Emory Rollins School of Public Health