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.
Integrity signals
Registry
Cites
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Claims the paper makes
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
Providing information on methods and data use has difficulties in balancing transparency.
“Difficulties in balancing transparency”
From AI Fairness in Data Management and Analytics: A Review on Challenges, Methodologies and Applications (2023) · cites this paper as [251]
Providing information on methods and data use increases data sharing and collaboration.
“Increases data sharing and collaboration”
From AI Fairness in Data Management and Analytics: A Review on Challenges, Methodologies and Applications (2023) · cites this paper as [251]
Clear communication of data collection process may lead to privacy concerns.
“May lead to privacy concerns”
From AI Fairness in Data Management and Analytics: A Review on Challenges, Methodologies and Applications (2023) · cites this paper as [251]
Clear communication of data collection process builds trust with data subjects.
“Builds trust with data subjects”
From AI Fairness in Data Management and Analytics: A Review on Challenges, Methodologies and Applications (2023) · cites this paper as [251]
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References 25 · Cited by 5
- Authors
- Alemayehu, D., Anziano, R. J., & Levenstein, M.
- Affiliations
- Pfizer (United States) (US)
- Corresponding author
- Alemayehu, Demissie
- Venue
- Contemporary Clinical Trials
- Publisher
- Elsevier BV
- Published
- 2014-09
- Volume
- 39
- Issue
- 1
- Pages
- 28-33
- ISSN
- 1551-7144 (ISSN-L)
- OpenAlex
- W2030736293
- Cited by
- 5
- References
- 25
- Citations by year
- 2025: 1 · 2023: 1 · 2018: 3
- FWCI
- 0.00
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Contemporary Clinical Trials (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Pfizer
- Yale University
- European Federation of Pharmaceutical Industries and Associations
- Topics
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmaceutical industry and healthcare
- Physical Sciences › Computer Science › Information Systems › Research Data Management Practices
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Keywords
- clinical trial data transparency, data disclosure, good clinical practice, patient privacy, scientific integrity, stakeholder collaboration
- MeSH terms
- Clinical Trials as Topic, Confidentiality, Drug Industry, Humans, Guidelines as Topic, Guideline Adherence, Disclosure, Health Information Exchange
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