Initiation, Regulatory Requirements, and Statistical Design for Research Studies Conducted at NIH

Purpose

The purpose of this webinar series is to provide an overview of the process, timeline, and resources for best research practices with a focus on data and statistical considerations.

Scheduled Speakers

Paige Studlack, Ph.D.
Clinical Protocol Coordinator
ffice of the Clinical Director
National Institute of Diabetes and Digestive and Kidney Diseases

Elizabeth C. Wright, Ph.D.
Mathematical Statistician
Biostatistics Program Office
National Institute of Diabetes and Digestive and Kidney Diseases

Sungyoung Auh, Ph.D.
Mathematical Statistician
Biostatistics Program Office
National Institute of Diabetes and Digestive and Kidney Diseases

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.