Zobrazeno 1 - 10
of 153
pro vyhledávání: '"Patient-focused drug development"'
Publikováno v:
Frontiers in Medicine, Vol 11 (2024)
Since its commencement as part of the Food and Drug Administration’s (FDA) Prescription Drug User Fee Act (PDUFA) V in 2012, patient-focused drug development (PFDD) has become an integral part of the drug development paradigm. FDA encourages the de
Externí odkaz:
https://doaj.org/article/6b0d2edc02bd4ec89e8bc667e5fcc799
Publikováno v:
Research Involvement and Engagement, Vol 10, Iss 1, Pp 1-11 (2024)
Abstract Background Engaging individuals living with disease in drug development and regulatory processes leads to more thoughtful and sensitive trial designs, drives more informative and meaningful outcomes from clinical studies, and builds trust be
Externí odkaz:
https://doaj.org/article/15b21f5fbf914c78a217489a730162f0
Autor:
Philipp Cimiano, Ben Collins, Maria Carmela De Vuono, Thierry Escudier, Jürgen Gottowik, Matthias Hartung, Mathias Leddin, Bikalpa Neupane, Raul Rodriguez-Esteban, Ana Lucia Schmidt, Cornelius Starke-Knäusel, Maarten Voorhaar, Krzysztof Wieckowski
Publikováno v:
Frontiers in Medicine, Vol 11 (2024)
Patients, life science industry and regulatory authorities are united in their goal to reduce the disease burden of patients by closing remaining unmet needs. Patients have, however, not always been systematically and consistently involved in the dru
Externí odkaz:
https://doaj.org/article/e5abb5d01e8e4320baa1e8a71fd224e8
Autor:
V. G. Borovskaya, A. R. Kasimova
Publikováno v:
Реальная клиническая практика: данные и доказательства, Vol 3, Iss 2, Pp 1-9 (2023)
About 10 years ago, the FDA launched an initiative to expand the role of patients in informing regulators and sponsors about the most serious consequences of the disease and the main treatment goals that can lead to desired medical outcomes. This ini
Externí odkaz:
https://doaj.org/article/9c1cbe9198bb4e9babeef27b281eeafc
Autor:
Bellinda L. King-Kallimanis, PhD, Andrea Ferris, MBA, Lisa Dropkin, BA, Mariel Molina, BS, Lydia Redway, BA, David E. Gerber, MD, Tracey L. Grant, MS, Upal Basu Roy, PhD
Publikováno v:
JTO Clinical and Research Reports, Vol 4, Iss 10, Pp 100575- (2023)
Introduction: The purpose of the informed consent form (ICF) is to outline the risks and benefits of an interventional clinical trial to potential participants. The aim of this study was to explore the feasibility of a short addendum to the ICF, summ
Externí odkaz:
https://doaj.org/article/eef9e7fd318843f9b76a9a9133843a9c
Publikováno v:
Frontiers in Artificial Intelligence, Vol 6 (2023)
Patients' increasing digital participation provides an opportunity to pursue patient-centric research and drug development by understanding their needs. Social media has proven to be one of the most useful data sources when it comes to understanding
Externí odkaz:
https://doaj.org/article/62ec055a97424f51b1240b066e9e6d18
Autor:
Anne-Sophie Michel, Paul Kamudoni, Alexia Marrel, Rocco Adiutori, Céline Desvignes-Gleizes, Sally Lanar, Peter Schache, Erica Spies, Josephine Park
Publikováno v:
Frontiers in Medicine, Vol 10 (2023)
ObjectiveIncluding qualitative research in clinical trial design is an innovative approach to understanding patients’ perspective and incorporate the patient’s voice in all stages of drug development and evaluation. This review aims to explore cu
Externí odkaz:
https://doaj.org/article/46bd236ceb9d42c5bc1ec0acb05df5a6
Akademický článek
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Akademický článek
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Publikováno v:
International Journal of COPD, Vol Volume 15, Pp 1789-1800 (2020)
Nuzhat Afroz,1 Florian S Gutzwiller,2 Alex J Mackay,3,4 Christel Naujoks,2 Francesco Patalano,5 Konstantinos Kostikas6,7 1Patient Access Services, Novartis Healthcare Private Limited, Hyderabad, India; 2Global Patient Access, Novartis Pharma AG, Base
Externí odkaz:
https://doaj.org/article/b3abd5f951ed4229a11638772dd5759b