American Society for Experimental Neurotherapeutics (ASENT) 2025 Clinical Trials Course

American Society for Experimental Neurotherapeutics (ASENT) 2025 Clinical Trials Course is organized by American Society for Experimental Neurotherapeutics (ASENT) and will be held from Mar 10 - 11, 2025 at Hyatt Regency Bethesda, Bethesda, Maryland, United States of America.

Description:
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.

The course will feature a mix of:

• 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
• Discounted access to the ASENT Annual Meeting

Curriculum:
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.

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.