Scrutinizing enrollment in ALS clinical trials: Room for improvement?
- 1 January 2008
- journal article
- research article
- Published by Taylor & Francis Ltd in Amyotrophic Lateral Sclerosis
- Vol. 9 (5), 257-265
- https://doi.org/10.1080/17482960802195913
Abstract
Enrollment in ALS trials has not been systematically studied. We surveyed the ALS Research Group (ALSRG) to learn their impressions of enrollment at ALS clinics across North America. We also reviewed completed ALS trials to determine an enrollment rate (subjects per site per month), its variability across trials, whether it is changing over time, and whether it is influenced by ‘trial factors’. ALSRG members were polled via an online survey. ALS trials were identified by literature review and investigator contact. Enrollment rate versus publication year was plotted for each trial. Models were created to examine how ‘trial factors’ were associated with enrollment rate. By survey, percent enrollment is 25% and highly variable (range 0–75%). By literature review, enrollment rate is 2.2 participants/site/month and highly variable (range 0.1–7.5). Enrollment is not improving over time; no ‘trial factor’ explains the variability in enrollment across trials. Behaviors among clinic directors and patients were identified that may influence enrollment. In conclusion, ALS trial enrollment rate is low, highly variable and not influenced by trial design factors. ‘Patient factors’ and ‘physician factors’ may play more important roles in influencing enrollment, as in oncology trials. Our survey data support this idea, and provide potential mechanisms for improving enrollment.Keywords
This publication has 19 references indexed in Scilit:
- Emerging disease-modifying therapies for the treatment of motor neuron disease/amyotropic lateral sclerosisEmerging Drugs, 2007
- The benefit of participating to clinical researchBreast Cancer Research and Treatment, 2005
- North East ALS Study GroupAmyotrophic Lateral Sclerosis, 2004
- Western ALS Study GroupAmyotrophic Lateral Sclerosis, 2004
- European ALS ConsortiumAmyotrophic Lateral Sclerosis, 2004
- Effect of a multidisciplinary amyotrophic lateral sclerosis (ALS) clinic on ALS survival: a population based study, 1996-2000Journal of Neurology, Neurosurgery & Psychiatry, 2003
- The ALSFRS-R: a revised ALS functional rating scale that incorporates assessments of respiratory functionJournal of the Neurological Sciences, 1999
- El escorial World Federation of Neurology criteria for the diagnosis of amyotrophic lateral sclerosisJournal of the Neurological Sciences, 1994
- Viability of Cancer Clinical Research: Patient Accrual, Coverage, and Reimbursement: American Medical Association Council on scientific AffairsJNCI Journal of the National Cancer Institute, 1991
- Randomised comparison of procedures for obtaining informed consent in clinical trials of treatment for cancer.BMJ, 1986