2019 Pre-Conference Workshop Registration
Cutting-Edge Issues in the Design of Behavioral Clinical Trials: What Every Investigator Should Know
TUESDAY, MARCH 5, 2019
12:00 p.m. – 6:00 p.m.
Room: Jefferson East
The Washington Hilton Hotel
Clinical trials are an essential method for testing the ability of behavioral interventions to modify risk factors and health-related behaviors, with the ultimate goal of preventing disease and improving health outcomes. However, the value of a trial is ultimately dependent on the rigor and reliability of the methods used in developing the intervention, designing the study, and implementing the trial itself. The effective design and conduct of behavioral clinical trials requires knowledge of standard clinical trial principles (randomization, sources of bias, masking, and equipoise) as well as an understanding of the unique complexities inherent in clinical trials of behavioral interventions that must be thoughtfully addressed. These complexities include answers to questions such as: What frameworks and methods are most useful for developing and optimizing the intervention? What is the appropriate role for pilot and feasibility studies in behavioral intervention research? What is a “pragmatic” trial, and how does one determine if a trial is pragmatic or explanatory? How does one decide on the type of control or comparison group to use in a behavioral clinical trial? Are there unique design and analytic methods appropriate for clinical trials that use group-based interventions? What methods are useful to reduce drop-outs and maximize trial engagement?
This workshop will address these and other critical issues in behavioral clinical trial development, design and implementation, as well as provide an overview of the latest NIH clinical trial policies and international efforts to build capacity and improve the quality of clinical trials. Whether you are a junior, mid-level or senior investigator, the information contained in these talks by leading clinical trial experts and NIH program officers will help you to design and conduct high quality, rigorous clinical trials, and the resources provided will deepen your knowledge of clinical trial design, methods, and implementation.