2025 Advanced CNS Clinical Trials Course

Jointly sponsored by ISCTM and ASCP
A brief, intensive, interactive program for mid-career CNS clinical researchers who wish to expand and refine their trial design expertise

11-13 June 2025
Raleigh NC

APPLY HERE
Application Deadline: 5 March 2025

Overall course objectives:

During this 2.25-day interactive course, approximately 40 selected students will work closely with CNS trial design and methods experts who represent academia, industry, and regulatory. The course is open to all applicants who meet training prerequisites.  Students will participate in interactive didactic sessions covering elements of early phase clinical trials, such as 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 sessions will include topics such as dose-finding strategies, signal detection risks and challenges, and the critical challenge of data interpretation in the context of go/no-go decisions.  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/preceptor-assisted small groups to design a protocol, integrating the clinical, relevant psychopharmacological, statistical, and regulatory lessons highlighted.

Faculty and preceptors:
Larry Alphs, MD, PhD, Larry Alphs Consulting
Stephen Brannan, MD, CNS Clinical Consulting
Carla Canuso, MD, Janssen Research and Development
Anita Clayton, MD, DLFAPA, IF, University of Virginia
Lori Davis, MD, Birmingham VA Medical Center
Ginger Haynes, PhD, Eli Lilly
Nanco Hefting, PharmD, H. Lundbeck A/S
Rebecca Hendrickson, MD, PhD, VA Puget Sound Health Care System
Seth Hopkins, PhD, Otsuka Pharmaceutical Development & Commercialization
Judith Jaeger, PhD, CognitionMetrics
Anzalee Khan, PhD, The Nathan S. Kline Institute for Psychiatric Research
Ni Khin, MD, Neurocrine Biosciences
Stephen Marder, MD, UCLA
Kari Nations, PhD, University of Texas at Austin
Luca Pani, MD, University of Miami / University of Modena
Elena Polverejan, PhD, Johnson & Johnson
Gerard Sanacora, MD, PhD, Yale University
Nina Schooler, PhD, SUNY Downstate Health Sciences Center

Faculty and Preceptor Disclosures

Agenda at a Glance

Optional Activities
Dine-around Opportunities with Faculty and Preceptors
Lite Breakfast with Faculty and Preceptors

Discussion topics focused on participants’ current challenges and questions

Registration Fees
Academia/Government: $300
Industry: $600

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

Training prerequisites:

• MD, PhD (applicable field), PharmD, PsyD, 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. Any who would like to be considered for these awards should indicate interest in support during the application process.

APPLY HERE