Format: In Person Application: Free Tuition: Free to Accepted Applicants Requirements: Application Info and CV Credentials: Certificate of Completion
Included: Accepted Applicants receive meals during the course and free full attendance to the Annual Meeting including dinner events. Not Included: Travel and Hotel is not included for all participants
About This Training Program
ASENT is pleased to offer a 1½-day course March 11-12, 2024 at the Hyatt Regency Bethesda, in Bethesda, MD to introduce researchers and clinicians to the principles of neurotherapeutic clinical trial development and implementation. The course will be especially relevant if you are 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 course will also address the unique challenges inherent in developing treatments for nervous system disorders.
Participants who attend the course will have ongoing access to senior faculty in attendance in a mentoring capacity. We anticipate that most applicants will have some familiarity with clinical research or will have attended the Training in Neurotherapeutics Drug Discovery and Development course; however, any clinical investigator who would benefit from the course is invited to apply. Those in industry and in private practice are also welcome to apply. There is no tuition or registration fee for successful applicants in 2024. The course will be offered annually and participants have full access to the ASENT Annual Meeting.
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.
This course is designed for those interested in conducting neurotherapeutic clinical trials. Applicants should have some familiarity with clinical research; however, any clinical investigator or research coordinator who would benefit from the course is invited to apply. Attendees of prior sessions of the Training in Neurotherapeutics Drug Discovery and Development course are invited to apply. Those in academia, industry and in private practice are also 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.)
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.
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 Early January, 2024. Enrollment will be limited to a maximum of 25 students for the 2024 course.
Learning Objectives This 1½-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
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, CEO, ProMIS Neurosciences
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
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.
The 2024 offering of ASENT’s Clinical Trials Course will be held Monday, March 11 - Tuesday, March 12, 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.