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The role of early-phase trials and real-world evidence in drug development.
Van Spall, Harriette G C; Bastien, Arnaud; Gersh, Bernard; Greenberg, Barry; Mohebi, Reza; Min, James; Strauss, Karsten; Thirstrup, Steffen; Zannad, Faiez.
Afiliación
  • Van Spall HGC; Department of Medicine, Department of Health Research Methods, Evidence, and Impact; Research Institute of St. Joseph's, McMaster University, Hamilton, Ontario, Canada.
  • Bastien A; Baim Institute for Clinical Research, Boston, MA, USA.
  • Gersh B; Bristol Myers Squibb, Princeton, NJ, USA.
  • Greenberg B; Department of Cardiovascular Medicine, Mayo Clinic College of Medicine and Science, Rochester, MN, USA.
  • Mohebi R; Division of Cardiology, UC San Diego Health, San Diego, CA, USA.
  • Min J; Division of Cardiology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
  • Strauss K; Cleerly, Denver, CO, USA.
  • Thirstrup S; Olink, Uppsala, Sweden.
  • Zannad F; European Medicines Agency, Amsterdam, the Netherlands.
Nat Cardiovasc Res ; 3(2): 110-117, 2024 02.
Article en En | MEDLINE | ID: mdl-39196202
ABSTRACT
Phase 3 randomized controlled trials (RCTs), while the gold standard for treatment efficacy and safety, are not always feasible, are expensive, can be prolonged and can be limited in generalizability. Other under-recognized sources of evidence can also help advance drug development. Basic science, proof-of-concept studies and early-phase RCTs can provide evidence regarding the potential for clinical benefit. Real-world evidence generated from registries or observational datasets can provide insights into the treatment of rare diseases that often pose a challenge for trial recruitment. Pragmatic trials embedded in healthcare systems can assess the treatment effects in clinical settings among patient populations sometimes excluded from trials. This Perspective discusses potential sources of evidence that may be used to complement explanatory phase 3 RCTs and to speed the development of new cardiovascular medications. Content is derived from the 19th Global Cardiovascular Clinical Trialists meeting (December 2022), involving clinical trialists, patients, clinicians, regulators, funders and industry representatives.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Desarrollo de Medicamentos Límite: Humans Idioma: En Revista: Nat Cardiovasc Res Año: 2024 Tipo del documento: Article País de afiliación: Canadá Pais de publicación: Reino Unido
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Desarrollo de Medicamentos Límite: Humans Idioma: En Revista: Nat Cardiovasc Res Año: 2024 Tipo del documento: Article País de afiliación: Canadá Pais de publicación: Reino Unido