Optimizing Neurologic Clinical Trial Design and Ensuring Equitable Enrollment*
Time: 11:45 AM to 12:45 PM
Description
Representation and selection of subjects in neurologic trials is of utmost important for successful trial recruitment and retention. Engagement with the target community to ensure trial design that accounts for lived experience, including novel metrics representative of participant burden and potential engagement in trials, considerations for trial design, including site visits and wearable devices, and a focus on equitable representation to more accurately reflect the affected population are all necessary components to the trial landscape. This session will explore these considerations and offer some novel considerations and metrics in this space.
Objectives
Implement new techniques and metrics for disease community engagement and retention.
Apply core concepts in participant representation to individual trials targeting the affected population of interest.
Utilize new metrics and frameworks in trial design.
Speakers
Diverse Population Considerations for ALS Trials
DescriptionMinority communities continue to be underrepresented in ALS and FTD clinical studies due to several factors, including socioeconomic barriers and bias in the medical and research community. This presentation will explore and identify the various obstacles hindering recruitment and retention of study participants with diverse backgrounds and the steps required to bridge the gap to enhance equity in neurodegenerative disorders clinical trial.
SpeakersMeasuring Side Effect Burden in Neurology: Development and Application of the Adverse Event Unit (AEU)
DescriptionTreatment options for patients with neurologic diseases are rapidly increasing. Given similar efficacy among new treatments, it is critical to develop ways to distinguish new and traditional treatments based on other features; in particular adverse events, cost, and treatment burden. The Adverse Event Unit (AEU) is a patient and physician weighted consensus unit designed to quantify and compare adverse event burden among any classes of treatment for neurologic conditions. This presentation will discuss the development of the AEU and the results of validation studies in the myasthenia gravis population.
SpeakersReducing Trial Non-Compliance and Increasing Trial Safety
DescriptionTo discuss how equitable inclusion and/or patient diversity can impact adverse event measurements.