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DIA/FDA Biostatistics Industry and Regulator Forum

Join us virtually from the comfort of your home/office March 29-31 or watch later at a time that works for you. This event provides access to the materials for a full two months!

Session 2: Complex Innovative Trials Designs: Current Perspectives and Future Directions

Session Chair(s)

Anup  Amatya, PhD

Anup Amatya, PhD

  • Lead Mathematical Statistician
  • FDA, United States
Lisa  Hampson, PhD

Lisa Hampson, PhD

  • Senior Director, Advanced Methodology & Data Science
  • Novartis Pharma AG, Switzerland
Any trial design that improves the speed, efficiency, or flexibility of drug development over the standard randomized controlled trial design could be described as innovative. Novel approaches to clinical trial designs may be needed to bring new treatments to patients faster, particularly in often rare and more targeted patient populations. Complex innovative trials may feature the use of early surrogate endpoints, adaptive designs permitting mid-study changes to the trial based on accruing data, Bayesian methods leveraging trial-external information, and master protocols studying several treatments or disease subtypes under the same overarching protocol. The use of the ICH E9(R1) estimand framework remains relevant for complex innovative designs when the objective is to estimate a treatment effect, where trials answering several questions will have multiple estimands which may evolve during the trial as a result of pre-planned adaptations. In this session, through discussion and case-studies, we will explore innovative approaches to clinical trial design and review how the estimand framework can be applied to complex innovative trials.
Learning Objective : At the conclusion of this session, participants should be able to:
  • Discuss regulatory perspectives on innovations in clinical trials
  • Identify issues relevant to applying the ICH E9(R1) framework to complex innovative trials
  • Explain Bayesian approaches to complex clinical trial design
  • Discuss practical issues associated with the implementation of complex innovative designs


Dionne  Price, PhD


Dionne Price, PhD

  • Deputy Director, Office of Biostatistics, OTS, CDER
  • FDA, United States
Olivier  Collignon


Olivier Collignon

  • Director
  • GlaxoSmithKline, United Kingdom
Melanie  Quintana, PhD

Complex Innovative Trials Designs: Current Perspectives and Future Directions

Melanie Quintana, PhD

  • Director & Senior Statistical Scientist
  • Berry Consultants, LLC, United States