Tackling challenging data integrity topics in 2020: update on good clinical practice perspectives from the US FDA and MHRA UK

NA Khin, C Grandinetti, H Dixey, B Yu… - Clinical …, 2022 - Wiley Online Library
With the globalization of clinical trials, regulators have increased collaboration to evaluate
the adequacy of clinical trial conduct and to optimize regulatory oversight. The 2020 joint …

[PDF][PDF] Clinical trial data transparency and GDPR compliance: Implications for data sharing and open innovation

T Minssen, N Rajam, M Bogers - Science and Public Policy, 2020 - academic.oup.com
Abstract Recent European Union (EU) initiatives and legislation have considerably
increased public access to clinical trials data (CTD). These developments are generally …

Putting data to work for precision medicine

A Bjerrum, U Lassen - Cell Reports Medicine, 2023 - cell.com
We discuss the One Stop Shop for Clinical Research (OSCAR) project that links clinical
data, patient-reported outcomes, genomic data, and health registry data, employing a …

Implementing clinical trial data sharing requires training a new generation of biomedical researchers

U Mansmann, C Locher, F Prasser, T Weissgerber… - Nature Medicine, 2023 - nature.com
Implementing clinical trial data sharing requires training a new generation of biomedical
researchers | Nature Medicine Skip to main content Thank you for visiting nature.com. You are …

Privacy policy and technology in biomedical data science

AM Arellano, W Dai, S Wang, X Jiang… - Annual review of …, 2018 - annualreviews.org
Privacy is an important consideration when sharing clinical data, which often contain
sensitive information. Adequate protection to safeguard patient privacy and to increase …

AI in healthcare: data governance challenges

JS Winter - Journal of hospital management and health policy, 2021 - par.nsf.gov
AI applications are poised to transform health care, revolutionizing benefits for individuals,
communities, and health-care systems. As the articles in this special issue aptly illustrate, AI …

The BioGuard Framework: Setting New Standards for Digital Biomarker Use in Clinical Trials

D Khedekar - 2024 - ASPET
Abstract ID 128908 Poster Board 406 Focus Area: Clinical Pharmacology, Clinical Trials
Background: Clinical trials globally struggle with a mere 10% success rate. Integrating digital …

[PDF][PDF] Accountability, secrecy, and innovation in AI-enabled clinical decision software

AK Rai, I Sharma, C Silcox - Journal of Law and the Biosciences, 2020 - academic.oup.com
This article employs analytical and empirical tools to dissect the complex relationship
between secrecy, accountability, and innovation incentives in clinical decision software …

THE RESEARCH EXEMPTION CARVE OUT

M Crescioni, T Sklar - Jurimetrics, 2020 - JSTOR
The use of medical and wellness devices containing sensor technology continues to evolve
as does the protection of an individual's data privacy for consumers as well as research …

[HTML][HTML] Strengthening research through data sharing

E Warren - New England Journal of Medicine, 2016 - Mass Medical Soc
Strengthening Research through Data Sharing | New England Journal of Medicine Skip to main
content The New England Journal of Medicine homepage Advanced Search SEARCH …