Advancing Clinical Trials: Master Protocols for Faster Drug Development | ESForum 15th Edition

Quick Overview

Master Protocols represent a paradigm shift in clinical trial design, offering a cohesive framework to test multiple hypotheses within a single overarching trial. By efficiently consolidating various sub-studies, multiple subpopulations and treatments, possible adaptive designs, and shared control arms, these protocols significantly enhance statistical power and operational efficiency.

They are particularly beneficial in the context of complex and multifaceted therapeutic areas, allowing for more robust and comprehensive data analysis, and facilitating faster, more flexible responses to emerging clinical evidence. This approach not only accelerates the pace of drug development but also enhances the flexibility and adaptability of clinical research.

However, it also adds some challenges like statistical complexity in determination of type I error rates or multiplicity control. Understanding and leveraging Master Protocols is critical for optimizing trial outcomes and accelerating the path to successful therapeutic innovations.

Key Conference Topics

The 15th edition of European Statistical Forum (ESForum) aims to explore methodologies, applications, and regulatory considerations associated with Master Protocols.
This will include presentations focusing on:

• The concept of master protocol designs, including umbrella trials, basket trials, and platform trials
• The statistical challenges and innovations in implementing master protocols
• The ethical and regulatory implications of these complex trial designs
• Case studies and real-world examples of successful master protocol implementations

In addition to the scientific sessions, this conference offers ample opportunities for networking and collaboration.

Scientific Board

Jens-Otto Andreas - BSO Business Operations Excellence Senior Lead, UCB Biosciences
Lisa Comarella - Senior Director Biostatistics, Alira Health Biometrics
Fabiola La Gamba - Senior Principal Statistician, Novartis
Victoria Strauss - Therapeutic Area Methodology Chapter Head, Boehringer Ingelheim

Who should attend?

This statistical conference is addressed to statisticians, pharmacometricians, data scientists, regulatory affairs specialists and other experts interested in the field belonging to: Pharmaceutical and Biotechnology companies, CROs, Universities/Hospitals and Research Institutes.

Networking Opportunities

• Industry expert roundtables
• Dedicated networking sessions
• Interactive workshops
• Collaborative discussion forums
• Case study presentations

Register now to join leading pharmaceutical companies, biostatisticians, and clinical researchers in advancing the future of clinical trials.