Clinical Trials Workshop:
Tracks
Risso 8
| Wednesday, November 6, 2019 |
| 1:45 PM - 3:15 PM |
| Risso 8 |
Overview
Clinical Trial Design: Can adaptive SCI trial designs accelerate acquisition of evidence to guide practice?
Speaker
Ms Linda Jones
Doctoral Student
University Of Colorado
Clinical Trial Design: Can adaptive SCI trial designs accelerate acquisition of evidence to guide practice?
Abstract
Overall Course Objective: Explore and the pros and cons of adaptive design approaches relative to traditional clinical trial designs in three research areas: Drugs/biologics, rehabilitation, physiological manipulation (intermittent hypoxia).
Learning Objectives:
1. Describe the current, traditional design of three current trials.
2. Present alternative adaptive trial design approaches.
3. Debate the pros and cons of traditional vs. adaptive designs.
Synopsis:
Medical evidence drives changes in practice through the scientific evaluation of emerging therapeutics. Traditional trial designs such as prospective randomized (1:1) controlled trials remain the “gold standard” in clinical research. Such trials are typically expensive, require several years to generate conclusions, and often have limited generalizability. Adaptive designs which incorporate accruing data can evolve based on probabilities determined during the study. Such designs are widely used in other medical fields such as cancer therapeutics. In the United States, the Food and Drug Administration has provided detailed assessments of the merits and limitations of adaptive trial designs that seek to define those who benefit and those who do not and subsequently focus only on responders. In this interactive workshop, we will present a brief summary of three ongoing clinical trials in the areas of drug, rehabilitation and physiologic manipulation (e.g. intermittent hypoxia). We will then discuss and debate how adaptive features could be integrated into these designs to improve their efficiency. The key considerations that favor or discourage these approaches will then be debated from the perspective of sponsors, regulators, statisticians and clinical trialists. We will wrap up with audience discussion on incorporation of alternative designs in future trials.
This workshop is sponsored by SCOPE (Spinal Cord Partnership Endeavors) and AO Spine.
Proposed agenda:
1. Introduction and workshop outline – 5 mins. (James Guest)
2. Traditional drug trial design and adaptive alternative with pro/con debate – 20 mins.
Armin Curt/James Guest
3. Traditional rehabilitation trial design and adaptive alternative with pro/con debate – 20 mins.
Edelle Field-Fote/James Guest
4. Intermittent hypoxia trial design and adaptive alternative with pro/con debate – 20 mins. Zev Rymer/James Guest
5. Audience discussion – 25 mins.
Moderator: James Guest, Panel Participants: Armin Curt, Edelle Field Fote, Zev Rymer
Learning Objectives:
1. Describe the current, traditional design of three current trials.
2. Present alternative adaptive trial design approaches.
3. Debate the pros and cons of traditional vs. adaptive designs.
Synopsis:
Medical evidence drives changes in practice through the scientific evaluation of emerging therapeutics. Traditional trial designs such as prospective randomized (1:1) controlled trials remain the “gold standard” in clinical research. Such trials are typically expensive, require several years to generate conclusions, and often have limited generalizability. Adaptive designs which incorporate accruing data can evolve based on probabilities determined during the study. Such designs are widely used in other medical fields such as cancer therapeutics. In the United States, the Food and Drug Administration has provided detailed assessments of the merits and limitations of adaptive trial designs that seek to define those who benefit and those who do not and subsequently focus only on responders. In this interactive workshop, we will present a brief summary of three ongoing clinical trials in the areas of drug, rehabilitation and physiologic manipulation (e.g. intermittent hypoxia). We will then discuss and debate how adaptive features could be integrated into these designs to improve their efficiency. The key considerations that favor or discourage these approaches will then be debated from the perspective of sponsors, regulators, statisticians and clinical trialists. We will wrap up with audience discussion on incorporation of alternative designs in future trials.
This workshop is sponsored by SCOPE (Spinal Cord Partnership Endeavors) and AO Spine.
Proposed agenda:
1. Introduction and workshop outline – 5 mins. (James Guest)
2. Traditional drug trial design and adaptive alternative with pro/con debate – 20 mins.
Armin Curt/James Guest
3. Traditional rehabilitation trial design and adaptive alternative with pro/con debate – 20 mins.
Edelle Field-Fote/James Guest
4. Intermittent hypoxia trial design and adaptive alternative with pro/con debate – 20 mins. Zev Rymer/James Guest
5. Audience discussion – 25 mins.
Moderator: James Guest, Panel Participants: Armin Curt, Edelle Field Fote, Zev Rymer
Biography
Dr. James Guest is a board certified Neurosurgeon and active scientist at the Miami Project to Cure Paralysis whose career focus has been on spinal cord injury. Dr. Guest has been involved in the North American Clinical Trials Network since 2005 and contributed to a registry of nearly 1000 subjects and the design of the RISCIS trial, riluzole in acute spinal cord injury. Dr. Guest serves as DSMB Chair for studies of epidural stimulation at the University of Louisville and the Grants Working Group of the California Institute for Regenerative Medicine. At the Miami Project he has served as co-PI on Phase 1 studies of autologous Schwann cell transplantation in subacute and chronic spinal cord injury. Dr. Guest has participated in SCOPE since its inception. In translational research his lab group conducts studies in large animals to test devices for advanced neuromonitoring, gene therapy, and neuromodulation.
