The goal of this two-day series is to provide researchers with the knowledge, tools, and resources to aid in the development of a scientific protocol for a clinical research study. Both sessions will begin at 9 a.m. and a question-and-answer session will follow each presentation.
On the second day of the series, we will take a "deeper dive" into clinical study design, statistics, and their impact on clinicaltrials.gov reporting:
- Clinical Protocol Study Design - aims, objectives, endpoints, and outcomes
- Statistical analysis, sample size considerations, data management
- Clinicaltrials.gov - registration and outcome measure reporting
- Protocol problem spots and ways to improve protocols
Target Audience: academic researchers, scientists, study coordinators, and students engaged in clinical research and/or clinical trials.
ACRP Contact Hours: The ACRP no longer approves 3rd party requests for CE credit. However, attendees are still welcome to self-report to ACRP for CE credit.
Statistical modeling for prediction requires a different frame of mind than more typical statistical modeling. In this seminar Jeff Laux, PhD, introduces predictive modeling as distinct from more common analyses and describes cross-validation, the central technique of predictive modeling.
The NC TraCS Biostatistics Seminar Series helps clinical and translational researchers collaborate more effectively with consulting biostatisticians by building deeper understanding of key statistical concepts and methods. Researchers then are better able to (1) evaluate relevance of the concept or method for research aim(s) definition and choice of study design; and (2) properly interpret the results of data analysis.
This NIH Collaboratory Rethinking Clinical Trials Grand Rounds features:
Thomas W. Carton, PhD, MS
Chief Data and Strategy Officer
Louisiana Public Health Institute
Anitha S. John, MD, PhD
Medical Director
Washington Adult Congenital Heart Program
Professor of Pediatrics
Children’s National Hospital
George Washington University