DIA 2024 Global Annual Meeting

Component Type: Workshop
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-527-L04-P; CME 1.00; RN 1.00

This workshop is a deep discovery of the potential and impact of master protocol for clinical development programs. These conversations are essential in challenging traditional clinical trials as a path forward for innovation in clinical research.

Learning Objectives

Recognize the history and basics of clinical research as it relates to master protocols; Compare and contrast master protocols to traditional (fixed sample size) and adaptive trial designs; Describe important methodological principles of master protocols and simulation-guided design; Discuss key benefits of master protocols for stakeholders of clinical development programs.

Chair

Muhammad Ali Hameed, CPA, MBA

Speaker

Facilitator
Jay Park, PhD, MSc

Facilitator
J. Kyle Wathen, PhD, MS

Component Type: Workshop
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-658-L04-P; CME 1.00; RN 1.00

Recruiting pediatric patients is a challenge and one of the solutions is to carefully design the study in an hybrid way to borrow adult data for pediatric study using innovative statistical techniques. The workshop discusses the recruitment challenges involved and then attendees will play a role of providing their thoughts on pediatric recruitment challenges. The workshop explains how well a study can be designed in an innovative way with appropriately utilizing the statistical techniques with case study to overcome recruitment challenges.

Learning Objectives

Discuss how to borrow historical adult data for pediatric study where recruiting pediatric patients is a huge challenging task.

Chair

Rajesh Kumar Gajendran, SR, MSc