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Improving Collection and Analysis of Overall Survival Data.
Rodriguez, Lisa R; Gormley, Nicole J; Lu, Ruixiao; Amatya, Anup K; Demetri, George D; Flaherty, Keith T; Mesa, Ruben A; Pazdur, Richard; Sekeres, Mikkael A; Shan, Minghua; Snapinn, Steven; Theoret, Marc R; Umoja, Rukiya; Vallejo, Jonathon; Warren, Nicholas J H; Xu, Qing; Anderson, Kenneth C.
Afiliación
  • Rodriguez LR; U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Gormley NJ; U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Lu R; Alumis Inc., South San Francisco, California.
  • Amatya AK; American Statistical Association, Alexandria, Virginia.
  • Demetri GD; U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Flaherty KT; Dana-Farber Cancer Institute, Boston, Massachusetts.
  • Mesa RA; Massachusetts General Hospital Cancer Center, Boston, Massachusetts.
  • Pazdur R; Atrium Health, Winston-Salem, North Carolina.
  • Sekeres MA; Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem, North Carolina.
  • Shan M; U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Snapinn S; Sylvester Comprehensive Cancer Center, University of Miami, Miami, Florida.
  • Theoret MR; Bayer, Whippany, New Jersey.
  • Umoja R; Seattle-Quilcene Biostatistics LLC., Seattle, Washington.
  • Vallejo J; U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Warren NJH; American Association for Cancer Research, Washington, District of Columbia.
  • Xu Q; U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Anderson KC; American Association for Cancer Research, Washington, District of Columbia.
Clin Cancer Res ; 30(18): 3974-3982, 2024 Sep 13.
Article en En | MEDLINE | ID: mdl-39037364
ABSTRACT
Advances in anticancer therapies have provided crucial benefits for millions of patients who are living long and fulfilling lives. Although these successes should be celebrated, there is certainly room to continue improving cancer care. Increased long-term survival presents additional challenges for determining whether new therapies further extend patients' lives through clinical trials, commonly known as the gold standard endpoint of overall survival (OS). As a result, an increasing reliance is observed on earlier efficacy endpoints, which may or may not correlate with OS, to continue the timely pace of translating innovation into novel therapies available for patients. Even when not powered as an efficacy endpoint, OS remains a critical indication of safety for regulatory decisions and is a key aspect of the FDA's Project Endpoint. Unfortunately, in the pursuit of earlier endpoints, many registrational clinical trials lack adequate planning, collection, and analysis of OS data, which complicates interpretation of a net clinical benefit or harm. This article shares best practices, proposes novel statistical methodologies, and provides detailed recommendations to improve the rigor of using OS data to inform benefit-risk assessments, including incorporating the following in clinical trials intending to demonstrate the safety and effectiveness of cancer therapy prospective collection of OS data, establishment of fit-for-purpose definitions of OS detriment, and prespecification of analysis plans for using OS data to evaluate for potential harm. These improvements hold promise to help regulators, patients, and providers better understand the benefits and risks of novel therapies.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Ensayos Clínicos como Asunto / Neoplasias Límite: Humans Idioma: En Revista: Clin Cancer Res Asunto de la revista: NEOPLASIAS Año: 2024 Tipo del documento: Article Pais de publicación: Estados Unidos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Ensayos Clínicos como Asunto / Neoplasias Límite: Humans Idioma: En Revista: Clin Cancer Res Asunto de la revista: NEOPLASIAS Año: 2024 Tipo del documento: Article Pais de publicación: Estados Unidos