Principles for Good Practice in the Conduct of Non-interventional Studies: The View of Industry Researchers.

Autor: 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.
Jazyk: angličtina
Zdroj: Therapeutic innovation & regulatory science [Ther Innov Regul Sci] 2023 Nov; Vol. 57 (6), pp. 1199-1208. Date of Electronic Publication: 2023 Jul 17.
DOI: 10.1007/s43441-023-00544-y
Abstrakt: 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).)
Databáze: MEDLINE
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