NIDDK Biostats Seminar Series: Initiation, Regulatory Requirements, and Statistical Design for Research Studies Conducted at the NIH
To Know
About this Class
NIDDK Biostats Seminar Series: From Research Study Design to Collecting, Managing, and Analyzing Data.
Learning Objectives
1. The learner should know the difference between observational studies, clinical trials (drug and non-drug studies), and secondary data (new data from stored samples, existing data) as defined for the NIH Clinical Center and how study development differs for each.
2. The learner should understand the development process, know the timeline, and know the resources available for successful protocol development.
3. The learner should understand the purpose and scope of ClinicalTrials.gov.
4. The learner should be able to identify and understand key data elements and each step of trial registration and reporting.
5. The learner should be able to understand the differences between a scientific hypothesis and a statistical hypothesis.
6. The learner should be able to translate scientific hypotheses into statistical design elements: study design, primary outcomes, statistical hypotheses, sample size calculation, and statistical analysis plan.
Tentative Webinar Outline:
2:30-3:00pm – Dr. Paige Studlack(Clinical Protocol Coordinator, NIDDK)
Research study types, timelines, and process for successful protocol development, IRB approval, and study initiation at the NIH, with particular emphasis on NIDDK resources and processes.
3:00– 3:30pm – Dr. Elizabeth Wright (Mathematical Statistician, Biostatistics Program Office, NIDDK)
Understanding ClinicalTrial.gov elements and how they are used in trial registration and reporting for studies at the NIH.
3:30-4:00pm – Dr. Sungyoung Auh (Mathematical Statistician, Biostatistics Program Office, NIDDK)
Translating scientific questions to needed statistical design elements for research study planning, documentation, completion, and reporting.