Experiences of and recommendations on clinical trial design in Alzheimer’s disease from the participant’s point of view: a mixed-methods study in two clinical trial centers in the Netherlands ...

Abstract Introduction In the context of the development of pharmaceutical interventions, expectations and experiences of participants are essential. Their insights may be particularly helpful to address the challenges of recruiting and retaining participants for Alzheimer’s disease (AD) clinical trials. We examined clinical trial participants’ experiences to optimize trial design in Alzheimer’s disease (AD). Method In this mixed-methods study, we included adults who participated in sponsor-initiated AD trials at Brain Research Center, a clinical trial organization in the Netherlands. Participa... Mehr ...

Verfasser: Ottenhoff, Lois
Vijverberg, Everard G. B.
Visser, Leonie N. C.
Verijp, Merike
Prins, Niels D.
Van der Flier, Wiesje M.
Sikkes, Sietske A. M.
Dokumenttyp: Datenquelle
Erscheinungsdatum: 2024
Verlag/Hrsg.: figshare
Schlagwörter: Medicine / Neuroscience / Science Policy / Mental Health
Sprache: unknown
Permalink: https://search.fid-benelux.de/Record/base-29167632
Datenquelle: BASE; Originalkatalog
Powered By: BASE
Link(s) : https://dx.doi.org/10.6084/m9.figshare.c.6595162

Abstract Introduction In the context of the development of pharmaceutical interventions, expectations and experiences of participants are essential. Their insights may be particularly helpful to address the challenges of recruiting and retaining participants for Alzheimer’s disease (AD) clinical trials. We examined clinical trial participants’ experiences to optimize trial design in Alzheimer’s disease (AD). Method In this mixed-methods study, we included adults who participated in sponsor-initiated AD trials at Brain Research Center, a clinical trial organization in the Netherlands. Participants (N = 71, age 69 ± 6.5, 54%F, 19 cognitively normal (CN), 19 mild cognitive impairment (MCI), and 33 AD dementia) first completed an online survey. Diagnostic group differences were investigated using chi-square tests or one-way ANOVAs. Next, a subsample (N = 12; 8 = CN, 4 = MCI) participated in focus groups to gain in-depth insight into their opinions on optimizing trial design from a participants’ point of view. ...