Year: 2023
Type: article
Abstract: BACKGROUND: Timely accrual of a representative sample is a key factor in whether Alzheimer's disease (AD) clinical trials successfully answer the scientific questions under study. Studies in other fields have observed that, over time, recruitment to trials has become increasingly reliant on larger numbers of sites, with declines in the average per-site recruitment rate. Here, we examined the trends in recruitment over a 20-year period of NIH-funded AD clinical trials conducted by the Alzheimer's Disease Cooperative Study (ADCS), a temporally consistent network of sites devoted to interventional research. METHODS: We performed retrospective analyses of eleven ADCS randomized clinical trials. To examine the recruitment planning, we calculated the expected number of participants to be enrolled per site for each trial. To examine the actual trial recruitment rates, we quantified the number of participants enrolled per site per month. RESULTS: No effects of time were observed on recruitment planning or overall recruitment rates across trials. No trial achieved an overall recruitment rate greater than one subject per site per month. We observed the fastest recruitment rates in trials with no competition and the slowest in trials that overlapped in time. The highest recruitment rates were consistently seen early within trials and declined over the course of studies. CONCLUSIONS: Trial recruitment projections should plan for fewer than one participant randomized per site per month and consider the number of other AD trials being conducted concurrently.
Source: Alzheimer s Research & Therapy
Institution: University of California, Irvine
Language: English
Topic: Ethics in Clinical Research
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,690
Awards: Institute for Clinical and Translational Science, G6886011585, Effects of Alzheimer's disease clinical trial study partners, G7857944114, Alzheimer's Disease Cooperative Study, Alzheimer's Clinical Trials Consortium (ACTC), The Alzheimer's Disease Research Center at the University of California, Irvine, Recruiting and retaining participants from disadvantaged neighborhoods in registries
OpenAlex ID: W4319003572