COVID-19 has dominated our lives for two years now. Although we are returning to a new normal, with the help of rapidly developed vaccines, do …

Through its issuance of recommendations and regulatory decisions concerning medical products, the US Food and Drug Administration (FDA) typically considers the “unmet medical need” surrounding …

As the world continues to adapt to the impact of the pandemic, a legacy has seen the evolvement of varying approaches to how clinical trials …

Each year, on the 20th of May, the global health community celebrates International Clinical Trials Day, the anniversary of James Lind’s famous scurvy experiment in …

Sample size has always been one of the first design choices a medical device sponsor has to make for a clinical study. But the calculation …