NOVEMBER 12, 2013
CTTI Project: Streamlining HABP/VABP Trials
Meeting Background:
The goal of this meeting is to seek practical solutions to streamline the operational processes and build efficiencies for data collection in HABP/VABP trials.
Meeting Location:
Arlington, Virginia
Meeting Presentations:
- Introduction by Pamela Tenaerts
Session 1: Challenges in data collection for HABP/VABP trials
Session 1 Goal: Understanding the issues surrounding data collection in HABP/VABP trials
Session 1 Focus: Why reducing excessive non-critical data collection in HABP/VABP trials would improve data quality, and benefit investigators, sponsors, reviewers, and patients
- Can we reduce complexity and safety data collection to improve the quality of the data and inferences we make? by Charles Knirsch
- Challenges in data collection for HABP/VABP trials: Investigator’s perspective by Richard Wunderink
- Data Collection in HABP/VABP Trials: Regulatory Perspective by Sumati Nambiar
Session 2: Regulatory requirements for AE data collection in registration trials
Session 2 Goal: Discuss different regulatory requirements and the challenges of meeting these requirements for data collection for HABP/VABP registration trials that are globally conducted, and evaluate whether future work is needed to harmonize approach to AE collection
Session 2 Focus: AE collection and adjudication of relatedness and seriousness; Reporting of SAE’s and SUSARS and evaluation
- Safety data collection in late stage premarket and post-approval clinical investigations by Patrick Archdeacon
- Managing safety data in multi-regional trials by Chris Wohlberg
Session 3: Strategies to simplify data collection using a QbD approach
Session 3 Goal: To simplify the recording, monitoring, and review to make HABP/VABP trials more feasible and economical
Session 3 Focus: Reduction in the amount of data collected by identifying data that are critical to quality and those that may be essential to determine the benefit/risk of the treatment for registration, and those may be less informative
- Using QbD for data collection planning by Mark Behm
- Guiding principles for efficient data collection- 20 years of cardiovascular outcomes trials by Lisa G. Berdan
- Breakout discussion instructions by Sabrina Comic-Savic
The views and opinions expressed in this presentation are those of the individual presenter and should not be attributed to the Clinical Trials Transformation Initiative, or any organization with which the presenter is employed or affiliated.