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Headlines from the DCI Network news feed for Sept 1-8, 2024
Joint and Interactive Associations of BMI and Genetic Factors with Cardiovascular Disease: A UK Biobank Study This study investigates the relationship between BMI, genetic factors, and cardiovascular disease, using data from the UK Biobank. The research sheds light on how BMI and genetic predispositions interact, providing valuable insights into tailored prevention strategies for cardiovascular disease based on genetic profiles.
https://bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-024-1…
European Health Data Space (EHDS) Regulation and Its Relevance for Biobanking A webinar led by experts from BBMRI.at explored the implications of the European Health Data Space (EHDS) regulation for biobanking. Key discussions centered on the secondary use of health data, ethical issues, and the legal responsibilities of biobanks as data holders. The webinar emphasized the importance of compliance with the EHDS and the role of national regulations in its implementation.
https://www.youtube.com/watch?v=aXd6qv6Y5wU
FDA Releases Final Guidance on Use of Real-World Data in Drug Approvals The FDA has released its final guidance on the use of real-world data (RWD) in drug approvals, signaling a shift towards the increased use of RWD to assess drug safety and efficacy. The guidance provides a framework for pharmaceutical companies to use electronic health records and medical claims data in their regulatory submissions.
Overview: · https://www.specialtypharmacycontinuum.com/FDA-News/Article/09-24/FDA-R…
Full Guidance:
https://www.fda.gov/regulatory-information/search-fda-guidance-document…
The Changing Landscape of Decentralized Clinical Trials This article highlights how decentralized clinical trials (DCTs) are expanding access to clinical research, particularly in underserved and remote populations. Technological advancements such as wearable devices and AI are facilitating continuous patient monitoring and data collection, while remote trials aim to improve diversity in clinical research participation.
https://themedicinemaker.com/business-regulation/the-changing-landscape…
Real-World Data on COVID-19 Vaccination Tolerability in Rheumatoid Arthritis Patients A new study presents findings on the tolerability of COVID-19 vaccines in rheumatoid arthritis patients. The research, based on patient-reported outcomes, shows that mRNA vaccines, such as Pfizer and Moderna, are well tolerated by RA patients, with minimal reservations about vaccination reported.
https://academic.oup.com/rheumap/advance-article/doi/10.1093/rap/rkae11…
Parexel Strengthens Real-World Research Offering Parexel has announced a strategic shift in its real-world research division, merging its real-world evidence (RWE) and scientific data teams to better meet the growing demand for high-quality RWE in drug development. The company aims to enhance patient outcomes by integrating real-world data into the drug lifecycle from early development to market approval.
https://newsroom.parexel.com/news-releases/news-release-details/parexel…
4 High-Value Use Cases for Synthetic Data in Healthcare Synthetic data is gaining traction in healthcare, offering solutions to challenges in data privacy, AI model training, and patient safety. This article highlights four key use cases where synthetic data is making a significant impact, including the development of AI models, clinical research, and addressing bias in medical data sets.
https://www.cyberera.com.ng/2024/09/06/4-high-value-use-cases-for-synth…
