Addressing the challenges to successful recruitment and retention in Alzheimer's disease clinical trials

Joshua D Grill,Jason Karlawish

doi:10.1186/alzrt58

Abstract

Among the key challenges in Alzheimer's disease drug development is the timely completion of clinical trials. Unfortunately, clinical trials often suffer from slow or insufficient enrollment. Successful clinical trial recruitment describes a balance between expeditiously achieving full enrollment and ensuring an appropriate study sample. Investigators face a number of challenges to the successful negotiation of this balance. The failure to address these challenges means that drug development may take more time and money and that trial results may not adequately represent drug efficacy or may not be applicable beyond the study. We review the challenges to recruitment and retention in Alzheimer's disease clinical trials and present a framework to address them.

Highlights

Alzheimer’s disease (AD) affects millions worldwide and is associated with tremendous human and financial costs
Because the prevalence of AD is increasing and no medications alter disease progression, there is great need for new therapies. Developing these therapies relies upon the clinical trial, but AD trials face challenges
After a review of the literature and experiences in AD clinical trial conduct, this paper summarizes the challenges related to AD trial recruitment and retention for phase II and phase III randomized, placebo-controlled trials of treatments that target the underlying biology or cognitive symptoms associated with AD

Summary

Introduction

Alzheimer’s disease (AD) affects millions worldwide and is associated with tremendous human and financial costs. Because the prevalence of AD is increasing and no medications alter disease progression, there is great need for new therapies. Developing these therapies relies upon the clinical trial, but AD trials face challenges. This review focuses on the challenges to effective recruitment and retention of participants. The failure to address these challenges has a number of costs. It can halt a trial, render a scientific question unanswered, and waste precious resources—most critically the time, effort, and health of participants

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Conclusion