quality and efficiency of clinical trials.
November 12, 2013
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.
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
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
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