Your browser doesn't support javascript.
loading
Bridging the Gap Between RCTs and RWE Through Endpoint Selection.
LoCasale, Robert J; Pashos, Chris L; Gutierrez, Ben; Dreyer, Nancy A; Collins, Toby; Calleja, Alan; Seewald, Michael J; Plumb, Jonathan M; Liwing, Johan; Tepie, Maurille Feudjo; Khosla, Sajan.
Afiliación
  • LoCasale RJ; Real World Evidence, Sanofi, Bridgewater, NJ, USA.
  • Pashos CL; AbbVie, Chicago, IL, USA.
  • Gutierrez B; GSK, Philadelphia, PA, USA.
  • Dreyer NA; IQVIA, Real-World Solutions, Cambridge, MA, USA.
  • Collins T; IQVIA, Real-World Solutions, London, UK.
  • Calleja A; IQVIA, Real-World Solutions, London, UK.
  • Seewald MJ; Novartis Pharma AG/Pharma Medical Affairs, Basel, Switzerland.
  • Plumb JM; Ferring Pharmaceuticals SA, St Prex, Switzerland.
  • Liwing J; CellProtect Nordic Pharmaceuticals, Stockholm, Sweden.
  • Tepie MF; Center for Observational Research, Amgen, Cambridge, UK.
  • Khosla S; Real-World Evidence Center of Excellence, AstraZeneca, Cambridge, UK. sajan.khosla@astrazeneca.com.
Ther Innov Regul Sci ; 55(1): 90-96, 2021 01.
Article en En | MEDLINE | ID: mdl-32632753
ABSTRACT
This commentary is authored by several industry real-world evidence (RWE) experts, with support from IQVIA, as part of the 'RWE Leadership Forum' a group of Industry Leaders who have come together as non-competitive partners to understand and respond to RWD/E challenges and opportunities with a single expert voice. Here, the forum discusses the value in bridging the industry disconnect between RTCs and RWE, with a view to promoting the use of RWE in the RCT environment. RCT endpoints are explored along several axes including their clinical relevance and their measure of direct patient benefit, and then compared with their real-world counterparts to identify suitable paths, or gaps, for assimilating RWE endpoints into the RCT environment.
Asunto(s)

Texto completo: 1 Base de datos: MEDLINE Asunto principal: Ensayos Clínicos Controlados Aleatorios como Asunto Tipo de estudio: Clinical_trials Límite: Humans Idioma: En Revista: Ther Innov Regul Sci Año: 2021 Tipo del documento: Article País de afiliación: Estados Unidos

Texto completo: 1 Base de datos: MEDLINE Asunto principal: Ensayos Clínicos Controlados Aleatorios como Asunto Tipo de estudio: Clinical_trials Límite: Humans Idioma: En Revista: Ther Innov Regul Sci Año: 2021 Tipo del documento: Article País de afiliación: Estados Unidos