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Better to be in The Placebo Arm for Trials of Neurological Therapies?

Patients with progressive neurodegenerative diseases often pursue trial entry seeking to access cutting edge therapies. However, cutting edge therapies for neurodegenerative diseases tend to have higher adverse event rates and underperform placebo. This essay argues that patients seeking trial entry...

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Detalles Bibliográficos
Autor principal: Kimmelman, Jonathan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: SAGE Publications 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6041887/
https://www.ncbi.nlm.nih.gov/pubmed/29855198
http://dx.doi.org/10.1177/0963689718755708
Descripción
Sumario:Patients with progressive neurodegenerative diseases often pursue trial entry seeking to access cutting edge therapies. However, cutting edge therapies for neurodegenerative diseases tend to have higher adverse event rates and underperform placebo. This essay argues that patients seeking trial entry are probably better off, medically, by being assigned to the placebo arm. Because trials involve extra clinic visits and research procedures, patients may be still better off medically by skipping trial participation altogether. I close by arguing that the Neurology research community might better honor the contributions of research subjects by pressing sponsors to promptly publish the results of non-positive trials, minimizing the use of uneven randomization ratios that favor assignment to the investigational treatment, and by fostering systematic collection of data on the risk/benefit balance of trial participation.