Lesley H. Curtis

Jan 17, 2025 | jamanetwork.com | Robert M. Califf |Ali Abbasi |Lesley H. Curtis

Consequences and Opportunities From Poor Uptake of COVID Vaccinations Despite Strong Evidence As we enter the winter season of viral illnesses, infections with SARS-CoV-2 (the virus that causes COVID-19), respiratory syncytial virus, and influenza are each on the rise, and there is increasing concern for a pandemic of avian influenza (ie, bird flu) given the enormous animal reservoirs for the virus.

Nov 15, 2024 | jamanetwork.com | Ali Abbasi |Lesley H. Curtis |Robert M. Califf

In Reply The letter by Mr Hauser and Dr Redberg commenting on our recent Special Communication1 on the role of payers in evidence generation raises questions regarding the evidence required at the time products are first approved and who should participate in generating evidence after that point. In our article we did not “propose that it is up to payers [instead of FDA] to ensure that benefits exceed harms” as the letter suggests.

Jun 3, 2024 | jamanetwork.com | Ali Abbasi |Lesley H. Curtis |Robert M. Califf

Traditional randomized clinical trials (RCTs) have long been a key tool underpinning drug and device development. The use of individual participant randomization and active or placebo controls in RCTs, combined with comprehensive collection of highly structured data, supports assay sensitivity. At the same time, focused enrollment criteria and careful attention to the collection of adverse events for specified follow-up periods promote detection of toxicities and risks.