Synergy in Action

Advanced CNS Clinical Trials Course

Jointly sponsored by ISCTM and ASCP
02 – 03 December, 2021   //   Raleigh, NC

A new, brief, intensive, interactive program for mid-career CNS clinical researchers who wish to expand and refine their trial design expertise

Overall course objectives:

During this 1.75-day interactive course, approximately 40 selected students will work closely with CNS trial design and methods experts who represent both academia and industry. Although open to all applicants who meet training prerequisites, this course will build on principles taught at the ASCP Clinical Trials Workshop.  Students will participate in interactive didactic sessions covering elements of early phase clinical trials, including proof-of-mechanism designs, target dosing for first efficacy trials, biomarker validation/interpretation, and the capacity for pre-clinical and biomarker work to reliably predict degree of effect in clinical trials. Later phase trial design topics will include dose-finding strategies, signal detection risks and challenges, and the critical challenge of data interpretation in the context of go/no-go decisions, follow-on grant applications, and publication.  Students will hear from statistical experts in the field who will shed additional light on strategies, controversies, risks, and known regulatory and reviewer/funding requirements in both early and later phase clinical trials. Course content will also address clinical trial design issues which are part of recent NIH RFAs and program announcements. After the didactic sessions, students will break into faculty-assisted small groups to design a protocol, integrating the clinical, relevant psychopharmacological, statistical, and regulatory lessons highlighted

Faculty and preceptors:
Carla Canuso, MD, Janssen Research and Development
Lori Davis, MD, Tuscaloosa VA Medical Center
Michael Davis, MD, PhD, FDA
Don Goff, MD, NYU School of Medicine
John Kane, MD, The Zucker Hillside Hospital
Bruce Kinon, MD, Lundbeck
Andy Krystal, MD, University of California, San Francisco
Craig Mallinckrodt, PhD, Biogen
Stephen Marder, MD, Semel Institute at UCLA
Kari Nations, PhD, Syneos Health
Bill Potter, MD, PhD, Independent expert (retired from NIMH, Lilly, and Merck)
Nina Schooler, PhD, SUNY Downstate Medical Center
Madhukar Trivedi, MD, University of Texas Southwestern Medical School
Daniel Umbricht, MD, F. Hoffmann-La Roche

Agenda at a Glance

8:00am EST Thursday, 2 December 2021
Intro: Carla Canuso
Early Phase Trials Session 1 – Proof of Mechanism Studies: Andy Krystal
Early Phase Trials Session 2 – Proof of Concept Studies: Daniel Umbricht
Early Phase Statistical Considerations: Craig Mallinckrodt
Pre-Breakout Practical Considerations: Kari Nations
Learning Lab Breakout A: Study Design Group Assignment
Late Phase Trials Session 1 – Confirmatory Industry Trials: Bruce Kinon
Late Phase Trials Session 2 – Multi-center Academic Trials: Lori Davis

Friday, 3 December 2021
Late Phase Statistical Considerations: Craig Mallinckrodt
Learning Lab Breakout B: Study Design Group Assignment
Group Discussion of Study Designs
Meeting adjourns: 1:30pm EST

Optional Activities
Dine Around with Faculty and Preceptors
Breakfast with Faculty and Preceptors

Topics such as Adaptive Designs, Regulatory Process, Biomarker Development and Validation, and Designing Multicenter Trials will be discussed during dinner and breakfast.

Registration Fees
Academia/Government: $250
Industry: $500

Who should attend:

  • Academia: Mid-career scientists
  • Government: Mid-career scientists
  • Industry: Associate Director to Senior Director level clinical/medical scientists
  • Clinical: Independent site investigators designing and conducting sponsored or investigator-initiated trials
  • Individuals who have attended the ASCP Clinical Trials Workshop (Clinical Trials in Psychopharmacology) are encouraged to attend this next-level program; however, prior ASCP trials workshop completion is not required, provided the individual meets other training prerequisites listed below

Training prerequisites:

  • MD, PhD (applicable field), PharmD, MS/PhD biostatistics, or MS/PhD epidemiology
  • At least 3 years’ experience designing and executing clinical trials
  • Some prior formalized clinical trial design training and/or supervised design experience mentored by senior trialists
  • Basic level of understanding of applicable inferential statistical principles, power analysis, and data interpretation
  • Working knowledge of neuropharmacology elements relevant to CNS clinical trial

Travel awards: Ten merit and need based travel award stipends will be granted to students seeking support.