학술논문
Principles for Good Practice in the Conduct of Non-interventional Studies: The View of Industry Researchers.
Document Type
Academic Journal
Author
Acha V; MSD, 2 Pancras Square, London, UK. virginia.acha@msd.com.; Barefoot B; GSK, London, UK.; Juarez Garcia A; BMS, London, UK.; Lehner V; Servier, Suresnes, Île-de-France, France.; Monno R; Chiesi, Parma, Italy.; Sandler S; Janssen-Cilag Limited, High Wycombe, UK.; Spooner A; AbbVie, Dublin, Ireland.; Verpillat P; Merck Healthcare KGaA, Darmstadt, Germany.
Source
Publisher: Springer International Publishing Country of Publication: Switzerland NLM ID: 101597411 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2168-4804 (Electronic) Linking ISSN: 21684790 NLM ISO Abbreviation: Ther Innov Regul Sci Subsets: MEDLINE
Subject
Language
English
Abstract
This reflection paper presents a consolidated view of EFPIA on the need for principles for good practice in the generation and use of non-interventional studies (NIS), including overarching principles such as the registration of hypothesis evaluating treatment effect (HETE) studies. We first define NIS and the important adjacencies to clinical trials and relationship with real-world evidence (RWE). We then outline the principles for good practice with respect to appropriate research design, study protocol, fit-for-purpose variables and data quality, analytical methods, bias reduction, transparency in conduct and use, privacy management and ethics review. We conclude with recommendations for action for the research community to promote trust and credibility in the use of NIS.
(© 2023. The Author(s).)
(© 2023. The Author(s).)