Patient safety Archives

The Risks and Rewards of Decentralized Clinical Trials

Business, Clinical Trials, Coronavirus Disease 2019 (COVID-19), Data quality, Decentralized Clinical Trials, Mobile, Patient safety, R&D, Researchers, Technology, Telemedicine

For years, researchers have been moving towards decentralized clinical trials (DCTs), and in a matter of months, COVID-19 changed the trajectory. Clinical operations teams and investigator sites around the world rose to the challenge and worked quickly to deploy new tactics to serve their study participants. The resulting reward is that DCTs, which can be leveraged smartly to reduce participant burden and improve recruitment and retention, are now becoming more widely adopted in design considerations. But rewards bring about new risks and challenges, and DCTs create new concerns for monitoring participant safety. Dario Lirio – Senior Director, LifeSphere Clinical at ArisGlobal – analyzes the risks and rewards of DCTs.

Moderna’s Covid-19 Vaccine Shows Early Promise

Antibodies, Clinical Trials, Coronavirus Disease 2019 (COVID-19), COVID-19 Vaccines, Data, Immune Response, Kaiser Permanente, Messenger RNA (mRNA) Vaccines, National Institutes of Health, New England Journal of Medicine, Patient safety, R&D, Researchers, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

According to data published in The New England Journal of Medicine, a Phase I trial of Moderna’s mRNA vaccine against SARS-CoV-2 demonstrated promising safety and immune response in all patients involved in the study.

FDA Acting Commissioner Outlines Regulatory Agency’s Four Top Priorities

21st Century Cures Act, Commissioner, Consumer Safety, FDA, FDA/Regulatory, Health Technology, Patient safety

U.S. FDA Acting Commissioner Ned Sharpless emailed staff outlining the regulatory agency’s four main priorities.