PL02: ADVANCES IN CLINICAL TRIAL DESIGN

Chair: Lisa McKerracher, PhD

Advances in SCI Clinical Trial Design

   Michael Fehlings, MD, PhD - University Health Network

Advances in TBI Clinical Trial Design

   Geoff Manley, MD, PhD - University of California, San Francisco

Panelists:

   David  Okonkwo, MD, PhD - UPMC Presbyterian

   Marco Rizzo, MD - Mayo Clinic

   Wise Young, MD, PhD - Rutgers University

Session Description

The pace of clinical research in neurotrauma has increased in recent years, with several clinical studies now progressing beyond Phase 1/2a.  Proof of efficacy studies differ from early safety studies in that careful selection of  the patient population and appropriate primary and secondary outcome measures is critical to clinical success in a fully randomized clinical study. This session will draw on examples from clinical studies in SCI and TBI.

Learning Objectives

At the conclusion of this session, attendees will be able to:

1. Understand the different targets being addressed to treat SCI and TBI
2. Understand the importance in clinical trial design to test functions important for patients
3. Understand common design aspects relevant for SCI and TBI