Mark your calendars for Drug Development in Pediatric Heart Failure: Extrapolation, Clinical Trial Design, and Endpoints, a one-day public workshop jointly sponsored by the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) and the Food and Drug Administration (FDA).
Scheduled for Friday, October 27, 2017 from 8:00 a.m. to 5:00 p.m., "Drug Development in Pediatric Heart Failure: Extrapolation, Clinical Trial Design, and Endpoints" will address challenges related to evaluation of products in pediatric heart failure including population to study, endpoints, extrapolation of adult efficacy data, innovative trial designs and statistical methods.
The workshop will provide an opportunity for relevant stakeholders, including representatives from academia, government, non-profit organizations, and industry, to discuss similarity of heart failure between adults and pediatric patients, trial design considerations, and use of innovative statistical and modeling approaches. Specifically, the workshop will include:
- Presentations on clinical manifestation and management of heart failure in pediatric patients, as compared to adults
- Discussion of alternative approaches to establishing efficacy including extrapolation of adult efficacy data, pharmacokinetic/pharmacodynamic endpoints, clinical endpoints, and innovative trial designs.
Stay tuned for more details about featured speakers and presentations.