Clinical Trials

In a recent episode of HBO Max’s The Pitt, an emergency-room attending physician shows medical students the time savings that can come from using a generative artificial intelligence (AI) tool to listen to a doctor–patient conversation and populate a medical record in seconds. But the same storyline highlights the downside: the tool invents details, confuses medications, and even swaps “neurology” for “urology”—mistakes that could put a patient at risk.

As a startup life science company, you are excited by the promising laboratory results for your novel drug, but you must first test the product’s safety and efficacy through clinical trials. To expedite the process, you work with a clinical research organization to conduct trials outside the United States.

Due to the pandemic, many ongoing clinical trials have faced disruptions due to restrictions on participant travel. As a result, researchers and sponsors quickly adapted their trial protocols to incorporate remote and decentralized approaches. This led to increased adoption of DCTs across a wide range of therapeutic areas. This article discusses the development of decentralized clinical trials and how companies can benefit from their increased prevalence.