Synergy in Action

Advanced CNS Clinical Trials Course

Jointly sponsored by ISCTM and ASCP
24 – 25 September, 2020   //   Cambridge, MA

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

Application period: 15 April-30 June
Request link to application

Overall course objectives:

During this 1.5-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 early phase topics, 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.

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

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
  • Foundational understanding of psychopharmacology elements relevant to CNS clinical trials

Faculty and preceptors:
Carla Canuso, MD, Janssen Research and Development
Lori Davis, MD, Tuscaloosa VA Medical Center
Robert Gibbons, PhD, University of Chicago
Don Goff, MD, NYU School of Medicine
John Kane, MD, The Zucker Hillside Hospital
Bruce Kinon, MD, Lundbeck
Andy Krystal, MD, Duke University
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