Day: June 6, 2024

Diversity of the participants in clinical trials has been a hot topic of discussion for the last decade fueled by the anemic data from such populations in market approval applications. So far, most of the focus has been on industry-funded trials but how do government-funded trials fare in their ability to recruit diverse populations? A … Read more

While the gold standard for pre-approval clinical trials is the randomized clinical trials (RCTs) design, post-market studies should follow the pragmatic clinical trial (PCT) design for better information about the drugs in the real world setting. FDA’s top management published a perspective this week that asserts that this would help better understand how well the … Read more