Increasing Challenges to Trial Recruitment and Conduct over Time
Abstract number :
2.256
Submission category :
7. Anti-seizure Medications / 7B. Clinical Trials
Year :
2023
Submission ID :
414
Source :
www.aesnet.org
Presentation date :
12/3/2023 12:00:00 AM
Published date :
Authors :
Presenting Author: Advith Reddy, – University of Michigan
Sung Hyun Seo, MD – University of Michigan Health; Neo Kok, BS – University of Michigan; William Stacey, MD, PhD – University of Michigan Medicine; John Stern, MD – UCLA Health; Page Pennell, MD – University of Pittsburgh School of Medicine; Jacqueline French, MD – NYU Langone Health; Wesley Kerr, MD, PhD – University of Michigan Medicine
Rationale:
This study aims to evaluate how the challenges in the recruitment and retention of participants in clinical trials for focal-onset epilepsy have changed over time.
Methods:
In this systematic analysis of randomized clinical trials of adjunct antiseizure medications for medication-resistant focal-onset epilepsy, we evaluated how the number of participants, sites, and countries has changed since the first such trial in 1990. We also evaluated the proportion of participants who completed each trial phase and their reasons for early trial exit. We analyzed these trends using mixed effects generalized linear models accounting for the influence of the number of trial sites and trial-specific variability.
Results:
The number of participants per site has steadily decreased over decades with recent trials recruiting fewer than five participants per site (reduction by 0.16 participants/site/year, p < 0.0001). Fewer participants also progressed from recruitment to randomization over time (Odds Ratio: 0.94/year, p = 0.014). Concurrently, there has been an increase in the placebo response over time (increase in median percent reduction of 0.4%/year, p = 0.02; odds ratio of increase in 50% responder rate of 1.03/year, p = 0.02), which was not directly associated with the number of sites per trial (p >
Anti-seizure Medications