title: Perspectives on clinical trial data transparency and disclosure.
abstract: The increased demand for transparency and disclosure of data from clinical trials sponsored by pharmaceutical companies poses considerable challenges and opportunities from a statistical perspective. A central issue is the need to protect patient privacy and adhere to Good Clinical and Statistical Practices, while ensuring access to patient-level data from clinical trials to the wider research community. This paper offers options to navigate this dilemma and balance competing priorities, with emphasis on the role of good clinical and statistical practices as proven safeguards for scientific integrity, the importance of adopting best practices for reporting of data from secondary analyses, and the need for optimal collaboration among stakeholders to facilitate data sharing.
authors.affiliation: Pfizer Inc., United States. Electronic address: demissie.alemayehu@pfizer.com.
authors.forename: Demissie
authors.initials: D
authors.lastname: Alemayehu
authors.affiliation: Pfizer Inc., United States.
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Anziano
authors.affiliation: Pfizer Inc., United States.
authors.forename: Marcia
authors.initials: M
authors.lastname: Levenstein
mesh_terms: D002986:Clinical Trials as Topic / Q000941:ethics*; D003219:Confidentiality; D030881:Disclosure / Q000941:ethics*; D004345:Drug Industry / Q000941:ethics* / Q000458:organization & administration; D019983:Guideline Adherence; D017408:Guidelines as Topic; D066275:Health Information Exchange; D006801:Humans
keywords: Clinical trial; Data sharing; Patient privacy; Transparency