We are a group of individuals from pharma, academia, and regulatory agency, within the Bayesian Scientific Working Group (BSWG), with special interest in pediatrics and therapeutic orphans.
Specific Objectives:
- To provide a venue for collaboration among professionals in pharma, academia and regulatory bodies and exchange learnings on challenges on pediatric drug development
- To explore statistical methodology that can be applicable in the design and analysis of clinical trials with particular interest in application to extrapolation and effective ways for communication of results.
- To illustrate based on existing successful development and provide advice on best practices that could be used by pharma and CRO statisticians in designing trials for pediatric therapeutics.
- To provide an environment for healthy debate among quantitative scientists and clinicians wholistic application of innovative design and challenges of clinical implementation.
- To disseminate information on research and best practices to broader scientific community as well as to engage in education efforts through conferences, workshops and seminars.
- Provide a repository information for statisticians in conduct of clinical trials for pediatrics.
How to join the Scientific Workgroup: Please send email to Meg Gamalo (Margaret.Gamalo@pfizer.com) or any of the members of the subteam.