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Methods for Neuroscience Drug Development: Guidance on Standardization of the Process for Defining Clinical Outcome Strategies in Clinical Trials.
Zaragoza Domingo, Silvia; Alonso, Jordi; Ferrer, Montse; Acosta, Maria T; Alphs, Larry; Annas, Peter; Balabanov, Pavel; Berger, Anna-Karin; Bishop, Kim I; Butlen-Ducuing, Florence; Dorffner, Georg; Edgar, Chris; de Gracia Blanco, Manuel; Harel, Brian; Harrison, John; Horan, William P; Jaeger, Judith; Kottner, Jan; Pinkham, Amy; Tinoco, Daniella; Vance, Monika; Yavorsky, Christian.
Afiliação
  • Zaragoza Domingo S; Neuropsychological Research Organization s.l. (Neuropsynchro), Barcelona, Spain. Electronic address: szaragoza@psyncro.net.
  • Alonso J; Hospital del Mar Research Institute; CIBER de Epidemiología y Salud Pública, Instituto de Salud Carlos III; Universitat Pompeu Fabra, Barcelona, Spain.
  • Ferrer M; Hospital del Mar Research Institute; CIBER de Epidemiología y Salud Pública, Instituto de Salud Carlos III; Universitat Pompeu Fabra, Barcelona, Spain.
  • Acosta MT; National Human Genome Research Institute (NHGRI), NIH, Washington, USA.
  • Alphs L; Denovo Biopharma, Princeton, New Jersey, USA.
  • Annas P; Alexion Pharmaceuticals, Inc., Copenhagen, Denmark.
  • Balabanov P; European Medicines Agency (EMA), Amsterdam, The Netherlands.
  • Berger AK; H. Lundbeck A/S, Copenhagen, Denmark.
  • Bishop KI; Global Pharma Consultancy, LLC, PA, USA.
  • Butlen-Ducuing F; European Medicines Agency, EMA, Amsterdam, The Netherlands.
  • Dorffner G; The Siesta Group, Vienna, Austria.
  • Edgar C; Cogstate, Ltd., London, UK.
  • de Gracia Blanco M; Universitat de Girona, Girona, Spain.
  • Harel B; Takeda Pharmaceuticals USA Inc, Cambridge, MA, USA.
  • Harrison J; Scottish Brain Sciences, Scotland, UK.
  • Horan WP; Karuna Therapeutics, Boston, MA, USA.
  • Jaeger J; Cognitionmetrics, Stamford, CT, USA.
  • Kottner J; Charité-Universitätsmedizin, Berlin, Germany.
  • Pinkham A; University of Texas Southwestern Medical Center, Dallas, TX, USA.
  • Tinoco D; Worldwide Clinical Trials, Barcelona, Spain.
  • Vance M; Santium, Toronto, Canada.
  • Yavorsky C; Valis Bioscience, Berkeley, CA, USA.
Eur Neuropsychopharmacol ; 83: 32-42, 2024 Jun.
Article em En | MEDLINE | ID: mdl-38579661
ABSTRACT
Neurosciences clinical trials continue to have notoriously high failure rates. Appropriate outcomes selection in early clinical trials is key to maximizing the likelihood of identifying new treatments in psychiatry and neurology. The field lacks good standards for designing outcome strategies, therefore The Outcomes Research Group was formed to develop and promote good practices in outcome selection. This article describes the first published guidance on the standardization of the process for clinical outcomes in neuroscience. A minimal step process is defined starting as early as possible, covering key activities for evidence generation in support of content validity, patient-centricity, validity requirements and considerations for regulatory acceptance. Feedback from expert members is provided, regarding the risks of shortening the process and examples supporting the recommended process are summarized. This methodology is now available to researchers in industry, academia or clinics aiming to implement consensus-based standard practices for clinical outcome selection, contributing to maximizing the efficiency of clinical research.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Neurociências / Ensaios Clínicos como Assunto / Desenvolvimento de Medicamentos Limite: Humans Idioma: En Revista: Eur Neuropsychopharmacol Assunto da revista: PSICOFARMACOLOGIA Ano de publicação: 2024 Tipo de documento: Article País de publicação: Holanda
Texto completo
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Neurociências / Ensaios Clínicos como Assunto / Desenvolvimento de Medicamentos Limite: Humans Idioma: En Revista: Eur Neuropsychopharmacol Assunto da revista: PSICOFARMACOLOGIA Ano de publicação: 2024 Tipo de documento: Article País de publicação: Holanda