Advanced CNS Clinical Trials Course 2021

Advanced CNS Clinical Trials Course 2021 is organized by The International Society for CNS Clinical Trials and Methodology (ISCTM), American Society of Clinical Psychopharmacology (ASCP) and will be held from Dec 02 - 03, 2021 at Syneos Health Headquarters, Raleigh, North Carolina, United States of America.

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

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.

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