The Human Cost: Patient Contribution to Clinical Trials in Neurology.

Autor: Reoma LB; Clinical Trials Unit, Office of the Clinical Director, Disorders and Stroke, National Institute of Neurological, National Institutes of Health, Bethesda, MD, 20892, USA. lauren.reoma@nih.gov., Karp BI; Division of Clinical Research, National Institute of Neurological Disorders and Stroke, National Institutes of Health, MD, 20892, Bethesda, USA.
Jazyk: angličtina
Zdroj: Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics [Neurotherapeutics] 2022 Sep; Vol. 19 (5), pp. 1503-1506. Date of Electronic Publication: 2022 Sep 09.
DOI: 10.1007/s13311-022-01292-x
Abstrakt: Drug development abounds with corporate pharmaceutical capital investment and expenditure costs for new therapeutics. However, there is little data on the human investment, in particular, the number of participants required or the potential burden on and cost to individual trial participants so instrumental to this endeavor. Indeed, the human participant burden in clinical trials is poorly, if at all, described in the literature and we could identify no reports that have detailed the participant burden unique to neurology trials. The cost of clinical trials to participants, including the unique circumstances affecting enrollment of diverse participant populations, has only begun to be reflected in the wider clinical trial literature. Additionally, details of the indirect costs, including time commitment, out-of-pocket expenses, emotional expenditure, and potential loss of enrollment into a more successful trial by participants in trials that fail - the majority in the field - is also particularly striking in the lack of representation in the literature. Even in successful clinical trials, participants in the placebo group face both an emotional burden and medical risk of morbidity and mortality without potential offsetting therapeutic benefit.
(© 2022. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.)
Databáze: MEDLINE
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