Ethical challenges in preclinical Alzheimer's disease observational studies and trials: Results of the Barcelona summit
Year: 2016
Type: article
Abstract: Alzheimer's disease (AD) is among the most significant health care burdens. Disappointing results from clinical trials in late-stage AD persons combined with hopeful results from trials in persons with early-stage suggest that research in the preclinical stage of AD is necessary to define an optimal therapeutic success window. We review the justification for conducting trials in the preclinical stage and highlight novel ethical challenges that arise and are related to determining appropriate risk-benefit ratios and disclosing individuals' biomarker status. We propose that to conduct clinical trials with these participants, we need to improve public understanding of AD using unified vocabulary, resolve the acceptable risk-benefit ratio in asymptomatic participants, and disclose or not biomarker status with attention to study type (observational studies vs clinical trials). Overcoming these challenges will justify clinical trials in preclinical AD at the societal level and aid to the development of societal and legal support for trial participants.
Source: Alzheimer s & Dementia
Institutions: Pasqual Maragall Foundation, Barcelonaβeta Brain Research Center, Universitat Pompeu Fabra, Hospital Clínic de Barcelona, Consorci Institut D'Investigacions Biomediques August Pi I Sunyer, Alzheimer's Association, Alzheimer Europe, European Medicines Agency, Prevent Alzheimer’s Disease 2020, National Institutes of Health, National Institutes of Health Clinical Center, Washington University in St. Louis, Inserm, Centre Hospitalier Universitaire de Lille, University of Edinburgh, Brigham and Women's Hospital, Harvard University, University of Pennsylvania
Language: English
Topic: Ethics in Clinical Research
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $4,200
Awards: G1073258374, G1602390028, G1732308444, G2074436950, G2489000106, G2880069213, G3123886232, G3207356259, G3919444319, G393177772, G40706755, Alzheimer's Disease Core Center, G4427631003, European Prevention of Alzheimer’s Dementia Consortium, G5702163051, Alzheimer's Disease Research Center, G6991793898, Dominantly Inherited Alzheimer Network, Antecedent Biomarkers for Alzheimer Disease: The Adult Children Study, Ethics of Emerging RCT Designs: Risk analysis and informed consent
OpenAlex ID: W2300746381