Sharing data from clinical trials: The rationale for a controlled access approach
Open accessAbstract
BACKGROUND: The move towards increased transparency around clinical trials is welcome. Much focus has been on under-reporting of trials and access to individual patient data to allow independent verification of findings. There are many other good reasons for data sharing from clinical trials. We describe some key issues in data sharing, including the challenges of open access to data. These include issues in consent and disclosure; risks in identification, including self-identification; risks in distorting data to prevent self-identification; and risks in analysis. These risks have led us to develop a controlled access policy, which safeguards the rights of patients entered in our trials, guards the intellectual property rights of the original researchers who designed the trial and collected the data, provides a barrier against unnecessary duplication, and ensures that researchers have the necessary resources and skills to analyse the data. METHODS: We briefly discuss the practicalities of our current approach to data sharing, including ensuring that data are discoverable and how to deal with old studies. We describe data sharing activities at the MRC Clinical Trials Unit. RESULTS: One hundred and three data sharing activities were logged from 2012 to 2014 from external and internal applicants. The motivations are varied, but none have been for replication of the primary results. CONCLUSIONS: For any request to share data, we note the important role of independent reviewers as well as reviewers who know the study well, and present some of the key questions that all reviewers should ask when deciding whether a request is reasonable. We consider the responsibilities of all parties. We highlight the potential for opportunity costs. Clinical trial data should be shared for reasonable requests but there are many practical issues that must be explicitly considered.
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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 [249]
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 [249]
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 [249]
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 [249]
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Facilitating access to clinical data from a randomized controlled trial of complex adaptive design
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- Authors
- Sydes, M. R., Johnson, A. L., Meredith, S. K., Rauchenberger, M., South, A., & Parmar, M. K.
- Affiliations
- MRC Clinical Trials Unit at UCL (GB)
- Corresponding author
- Sydes, Matthew R
- Venue
- Trials
- Published
- 2015-03-23
- Volume
- 16
- Issue
- 1
- Pages
- 104-104
- ISSN
- 1745-6215 (ISSN-L)
- PMC
- PMC4369803
- OpenAlex
- W2130462624
- Cited by
- 67
- References
- 11
- Citations by year
- 2026: 2 · 2025: 3 · 2024: 1 · 2023: 7 · 2022: 2 · 2021: 5 · 2020: 20 · 2019: 4 · 2018: 3 · 2017: 9 · 2016: 7 · 2015: 4
- FWCI
- 20.54
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- Trials (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- UCL Discovery (University College London) (submittedVersion)
- Funders
- Medical Research Council (MC_UU_12023/24)
- Topics
- Physical Sciences › Computer Science › Information Systems › Research Data Management Practices
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Social Sciences › Decision Sciences › Information Systems and Management › Academic Publishing and Open Access
- Keywords
- clinical trial data sharing, controlled access, individual patient data, data access policy, patient consent, data anonymization, intellectual property, data discoverability, opportunity cost
- MeSH terms
- Data Anonymization, Clinical Trials as Topic, Cooperative Behavior, Humans, Informed Consent, Policy Making, Research Design, Databases, Factual, Access to Information, Disclosure, Information Dissemination
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