Výsledky vyhledávání - "real-world evidence (RWE)"

Akademický článek

Is Canada Moving towards a More Agile Regulatory Approval and Reimbursement Process with a Shifting Role for Real-World Evidence (RWE) for Oncology Drugs?

Autor: Catherine Y. Lau, Nigel S. B. Rawson

Publikováno v: Current Oncology, Vol 31, Iss 9, Pp 5599-5607 (2024)

Canada is known to have a complex pathway for new drug approval and reimbursement, resulting in delayed access for patients with serious and life-threatening diseases, such as cancer. Several recent publications from key stakeholders, including patie

Externí odkaz: https://doaj.org/article/f93c407c05234ae4a935cd5827261ee2

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Akademický článek

Efficacy of brodalumab in psoriasis patients with a body weight >100 kg: Real‐world evidence (RWE) from the LIBERO study.

Autor: Kiedrowski, Ralph¹ (AUTHOR) dr.vonkiedrowski@cmss-selters.de, Asadullah, Khusru^2,3 (AUTHOR), Korge, Bernhard⁴ (AUTHOR), Tsarovina, Konstantina⁵ (AUTHOR), Augustin, Matthias⁶ (AUTHOR)

Publikováno v: JEADV Clinical Practice. Nov2024, p1. 8p. 1 Illustration, 2 Charts.

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Long-term treatment for unspecified anxiety disorders with cannabidiol (CBD): A retrospective case series from real-world evidence (RWE) in Colombia

Autor: Juan F. Galvez-Florez, Hernan F. Guillen-Burgos, Camilo A. Flórez-Puentes, Cristian E. Navarro, Guillermo Moreno-Sanz

Publikováno v: Medical Cannabis and Cannabinoids, Pp 1-26 (2024)

Introduction: Preclinical and clinical evidence has elucidated that cannabis based medical formulations (CBMFs) may display anxiolytic, anti-depressive, and neuro-protective properties. CBMFs are often considered as novel therapeutic anxiolytic agent

Externí odkaz: https://doaj.org/article/494b06f314a44d578d4ed9e8a42c7eb2

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Akademický článek

Observational study examining the feasibility of generating real-world evidence (RWE) for new drug applications from the clinical trials database (DB; RELIASE study).

Autor: Bando, Hideaki, Misumi, Toshihiro, Sakamoto, Yasutoshi, Takeda, Yuriko, Nakamura, Yoshiaki, Mizuguchi, Kazuya, Aoyagi, Yoshihiro, Miki, Izumi, Yoshino, Takayuki, Ohtsu, Atsushi

Publikováno v: Journal of Clinical Oncology; 2024 Supplement, Vol. 42, pTPS100-TPS100, 48p

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Akademický článek

A systematic review of real-world evidence (RWE) supportive of new drug and biologic license application approvals in rare diseases.

Autor: Vaghela, Shailja¹ (AUTHOR), Tanni, Kaniz Afroz² (AUTHOR), Banerjee, Geetanjoli³ (AUTHOR) geetanjoli.banerjee@modernatx.com, Sikirica, Vanja³ (AUTHOR)

Publikováno v: Orphanet Journal of Rare Diseases. 3/12/2024, Vol. 19 Issue 1, p1-12. 12p.

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A systematic review of real-world evidence (RWE) supportive of new drug and biologic license application approvals in rare diseases

Autor: Shailja Vaghela, Kaniz Afroz Tanni, Geetanjoli Banerjee, Vanja Sikirica

Publikováno v: Orphanet Journal of Rare Diseases, Vol 19, Iss 1, Pp 1-12 (2024)

Abstract Background Real-world evidence (RWE) generated using real-world data (RWD) presents the potential to contextualize and/or supplement traditional clinical trials for regulatory approval of rare diseases (RDs). This systematic review evaluated

Externí odkaz: https://doaj.org/article/8a14dcfb81614b6fbc95c17d33af8325

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