2025 Training in Neurotherapeutic Clinical Trials:
Development and Implementation

Course Overview

 CLINICAL TRIALS COURSE APPLICATION 

APPLICATION DEADLINE EXTENDED: November 19, 2024

Format: In Person
Application: Free
Tuition: $450 for Accepted Applicants (includes access to Annual Meeting)
Requirements: Completed Application
Credentials: Certificate of Completion

Not Included: Travel and Hotel is not included for all participants

About This Training Program

ASENT is pleased to offer a 2-day course March 10-11, 2025 at the Hyatt Regency Bethesda, in Bethesda, MD to introduce clinicians interested in clinical research to the principles of neurotherapeutic clinical trial development and implementation. The course will be especially relevant if you are a neurologist with clinical experience interested in conducting neurotherapeutic clinical trials.

The course covers the principles of clinical trials from pre-clinical programs to Phase III design and implementation, including necessary regulatory conversations and IND enabling studies, IRB oversight and adverse event tracking and reporting. The course considers clinical trials in the neurotherapeutic space for both drugs and devices. The faculty will also address the unique challenges inherent in developing treatments for nervous system disorders.

This year, we have expanded on those features of the course that proved to bring participants the most immediate value.

Course Will Feature

• Didactic sessions that go in depth into a wide range of topics

• Interactive workshops where participants will work in teams on projects such as drafting protocols and addressing adverse events 

• Panel discussions with lively Q&A 

• Networking dinners with industry leaders

We are excited to have the opportunity to offer this course, which we believe will help to advance the availability of new drugs for patients with neurological conditions. If your work would benefit from an understanding of neurologic clinical trials you are encouraged to apply.

Eligibility

This course is designed for those interested in conducting neurotherapeutic clinical trials. Applicants should have some familiarity with clinical research; however, any clinical investigator who would benefit from the course is invited to apply. Those in academia, industry and in private practice are encouraged welcome to apply. As the course will be held in person at the Hyatt Regency Bethesda, in Bethesda, MD, applicants must be available to attend the entire course in person. (Virtual option is not available at this time.)

Apply

All applicants must apply using the online process, which can be initiated using the link below or at the top of the page. Upon entering your information you will be sent an email providing you with a link to complete the application. All that is required is basic information and your CV.

 CLINICAL TRIALS COURSE APPLICATION 

Selection Process

Applicants will be evaluated based on the strength of their CV and likelihood to implement the learnings from the course. Applicants will be notified of their acceptance in November, 2024. Enrollment will be limited to a maximum of 50 students for the 2025 course. 

Learning Objectives

This 2-day course will introduce researchers and clinicians to the principles of neurotherapeutic clinical trial development and implementation and will provide participants with knowledge elements required to successfully conduct a neurotherapeutic clinical trial as a site lead or team member.

The training, which is designed to be applicable to diverse diseases of the nervous system, will equip students with a broad understanding of the various component steps in the clinical trial process.

Students will learn:

• The genesis of clinical trials

• Present structure of clinical trials 

• About preclinical and IND Enabling Studies

• The process complexity of selecting sites and investigators

• Steps required to ensure safety and efficacy within Phase I and II

• About the design and implementation of multicenter trials in Phase III

• How to address issues in drafting protocols and assessing adverse events

• The practical aspects of Phase III data

In sum, students will be equipped with the skills to conduct a neurotherapeutic clinical trial as a site lead or team member, and work collaboratively with subject experts in each of the component areas.

Course Design

The course combines didactic lectures with active engagement activities in which the students will be challenged to utilize the lecture material during group workshops on protocol design and adverse events.

This course is designed to provide clinicians with the practical skills necessary to successfully lead neurotherapeutic clinical trial sites. ASENT has created this new mechanism to support the education and development of clinicians to become high quality trialists. 

Course Topics

Some of the topics covered in the course include:

• Introduction and broad overview of the genesis of clinical trials and the protection of human participants

• Present structure, with a focus on phases and types of trials, equipoise, oversight, and informed consent

• Discovery, translation of novel mechanisms into a viable target for treatment, and toxicology studies

• Process of obtaining investigational new drug and investigational device exemption status for clinical trials

• Complexities of selecting sites and investigators

• Phase I - safety, tolerability, pharmacokinetics, and pharmacodynamics

• Phase II - demonstrating efficacy

• Phase III - Implementation of multicenter trials

• Adverse Events -  recognition, evaluation, and reporting

• The elements involved in Protocol design

• Practical aspects of Phase III data, including data concerns, capture and reporting
  
  

Faculty

The course faculty is made up of leaders in the field of Neurotherapeutics throughout industry, academia, and government, and offer a depth of expertise in clinical trials that is unparalleled. Each presenter has a deep subject matter expertise and an enormous base of experience so as to benefit participants both during the course and in the years following. Below you will find a list of our esteemed faculty:

• Debra Ehrlich, MD, MS, Director of the Parkinson's Disease Clinic, Intramural Research, NINDS, Program Director for the Clinical Movement Disorders Fellowship Program, NIH
• Gail Farfel, PhD, Consultant
• W. Douglas Figg, Sr., PharmD, Senior Investigator, NIH
• Nichol McBee, MPH, Research Associate, Project Lead, Johns Hopkins University Trial Innovation Center, Johns Hopkins School of Medicine
• W. Andrew Mould, MPH, Research Associate, Associate Director,  BIOS Clinical Trials Coordinating CenterJohns Hopkins School of Medicine
• Svetlana Shore, PhD, Director, Clinical Development, Neurocrine Biosciences
• Kenneth Sommerville, MD, Consultant, Sommerville Consulting
• Lauren Reoma, MD, Deputy Clinical Director, and Director, Clinical Trials Unit, Office of the Clinical DirectorNIH
  
• Michael Rogawski, MD, PhD, Professor, Neurology, UC Davis
• Robert Wechsler, MD, PHD, FAES, FAAN, Consultants in Epilepsy & Neurology PLLC

Continuing Engagement Activities Following the Course

Students will be encouraged to connect with faculty mentors following the course. In an effort to facilitate these connections both students and faculty will have several opportunities to network during the ASENT Annual Meeting immediately following the course. These networking opportunities will help foster these connections to ensure they are lasting relationships that course participants can access in the future. 

Course Venue

The 2025 offering of ASENT’s Clinical Trials Course will be held Monday, March 10 - Tuesday, March 11, 2024 at the Hyatt Regency Bethesda in Bethesda, Maryland. The course will be held in person only - no virtual option is available at this time. 

Course Location

Hyatt Regency Bethesda, Bethesda MD

Contact
Please direct all application questions to caroline@asent.org

 CLINICAL TRIALS COURSE APPLICATION