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Adaptive Platform Trials to Transform Amyotrophic Lateral Sclerosis Therapy Development.
Paganoni, Sabrina; Berry, James D; Quintana, Melanie; Macklin, Eric; Saville, Benjamin R; Detry, Michelle A; Chase, Marianne; Sherman, Alexander V; Yu, Hong; Drake, Kristin; Andrews, Jinsy; Shefner, Jeremy; Chibnik, Lori B; Vestrucci, Matteo; Cudkowicz, Merit E.
  • Paganoni S; Sean M. Healey & AMG Center for ALS and Neurological Clinical Research Institute, Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Boston, MA.
  • Berry JD; Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, MA.
  • Quintana M; Sean M. Healey & AMG Center for ALS and Neurological Clinical Research Institute, Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Boston, MA.
  • Macklin E; Berry Consultants, Austin, TX.
  • Saville BR; Biostatistics Center, Massachusetts General Hospital, Harvard Medical School, Boston, MA.
  • Detry MA; Berry Consultants, Austin, TX.
  • Chase M; Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, TN.
  • Sherman AV; Berry Consultants, Austin, TX.
  • Yu H; Sean M. Healey & AMG Center for ALS and Neurological Clinical Research Institute, Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Boston, MA.
  • Drake K; Sean M. Healey & AMG Center for ALS and Neurological Clinical Research Institute, Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Boston, MA.
  • Andrews J; Sean M. Healey & AMG Center for ALS and Neurological Clinical Research Institute, Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Boston, MA.
  • Shefner J; Sean M. Healey & AMG Center for ALS and Neurological Clinical Research Institute, Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Boston, MA.
  • Chibnik LB; Columbia University, New York City, NY.
  • Vestrucci M; Barrow Neurological Institute, Phoenix, AZ.
  • Cudkowicz ME; Biostatistics Center, Massachusetts General Hospital, Harvard Medical School, Boston, MA.
Ann Neurol ; 91(2): 165-175, 2022 02.
Article en En | MEDLINE | ID: mdl-34935174
Current therapeutic development in amyotrophic lateral sclerosis (ALS) relies on individual randomized clinical trials to test a specific investigational product in a single patient population. This approach has intrinsic limitations, including cost, time, and lack of flexibility. Adaptive platform trials represent a novel approach to investigate several interventions for a single disease in a continuous manner. Already in use in oncology, this approach is now being employed more often in neurology. Here, we describe a newly launched platform trial for ALS. The Healey ALS Platform Trial is testing multiple investigational products concurrently in people with ALS, with the goal of rapidly identifying novel treatments, biomarkers, and trial endpoints. ANN NEUROL 2022;91:165-175.
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Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Proyectos de Investigación / Ensayos Clínicos como Asunto / Esclerosis Amiotrófica Lateral Tipo de estudio: Clinical_trials / Prognostic_studies Límite: Animals / Humans Idioma: En Año: 2022 Tipo del documento: Article
Texto completo
Imprimir
XML
PubMed Links
Search on Google

Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Proyectos de Investigación / Ensayos Clínicos como Asunto / Esclerosis Amiotrófica Lateral Tipo de estudio: Clinical_trials / Prognostic_studies Límite: Animals / Humans Idioma: En Año: 2022 Tipo del documento: Article