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What CITI Program is Reading – 2/23/21
“What CITI Program is Reading” is our weekly blog series which highlights news articles curated by our staff and relevant to research, higher education, healthcare, technology, and more. Follow us on LinkedIn for upcoming editions and more information from CITI Program. The next act for messenger RNA could be bigger than covid vaccines Messenger RNA […]
Download Achieving Diversity, Inclusion, and Equity in Clinical Research
The Multi-Regional Clinical Trials (MCRT) Center is a research and policy center associated with Brigham and Women’s Hospital and Harvard University. As part of their vision to improve the integrity, safety, and rigor of global clinical trials, The Multi-Regional Clinical Trials (MCRT) Center has released version 1.1 of their comprehensive guidance and toolkit “Achieving Diversity, […]
Alleged False Claims Acts Violations Prove Costly for Healthcare Company and Lab
Cordant Health Solutions, which provides healthcare testing and monitoring nationwide, have agreed to pay $845,108 to federal and state governments as part of a civil settlement agreement. The Office of the Inspector General for the Department of Health and Human Services, and the Connecticut Office of the Attorney General alleged that Cordant violated the False […]
What CITI Program is Reading – 2/16/21
“What CITI Program is Reading” is our weekly blog series which highlights news articles curated by our staff and relevant to research, higher education, healthcare, technology, and more. Follow us on LinkedIn for upcoming editions and more information from CITI Program. Sanofi to help produce 100 million Pfizer/BioNTech vaccine doses The French biopharmaceutical company aims […]
Wearable Device Data Identifies COVID-19 Infection and Predicts Diagnosis
A recent observational study by the Icahn School of Medicine at Mount Sinai has shown that physiological data from a wearable device can predict COVID-19 infection and symptoms. Metrics collected from Health care workers wearing Apple Watches in the Mount Sinai Health System showed significant changes in heart rate variability (HRV) among subjects with COVID-19 […]
Practical, Efficient, and Cost-Effective Study Designs in Observational Research
Introduction Clinical research has taught us vital public health lessons over the years. We now know that smoking is a significant risk factor for emphysema, being overweight can lead to pre-diabetes, and drinking a glass of red wine with dinner offers benefits beyond winding down after a tough day. While randomized clinical trials (RCTs) are […]
What CITI Program is Reading – 2/9/21
Welcome to the first edition of our weekly blog series, “What CITI Program is Reading,” which highlights news articles curated by our staff and relevant to research, higher education, healthcare, technology, and more. Follow us on LinkedIn for upcoming editions and more information from CITI Program. WHO publishes public health research agenda for managing infodemics […]
FDA’s New AI/ML Device Regulation Action Plan
On 12 January 2021, the FDA announced a five-part action plan creating a framework which would enable FDA to further their oversight as well as provide a reasonable assurance of safety and effectiveness of artificial intelligence and machine learning-based software as a medical device (SaMD). This multi-faceted plan includes: Tailored Regulatory Framework for AI/ML-based SaMD […]
CDC and Vaccine Safety
On 22 December 2020 the U.S. Centers for Disease Control and Prevention (CDC) updated their Ensuring the Safety of COVID-19 Vaccines in the United States webpage. The CDC highlights a number of expanded and existing safety monitoring systems associated with monitoring vaccine safety. You will also find links to the their “V-safe After Vaccination Health […]