Data-informed clinical research: zooming in on external control arms 🔍 Recent advancements in data science & technology have made way for a new virtual counterpart to the control group. These ‘external control arms’ draw data from historical clinical trials or RWD sources like electronic health records. They offer a solution for scenarios where recruiting a control arm is not feasible, for instance in the case of rare or life-threatening conditions with no or inadequate treatment options. Research suggests external control arms can reduce sample size requirements by up to 20-50%, leading to significant cost-savings while also speeding up recruitment timelines. In this article, we cover FDA guidance on externally controlled trials and 2 biopharma companies that successfully applied this approach. 👉 Link: triall.io/articles/beyond-randomised-controlled-trials-how-external-control-arms-could-change-the-game 🗣 Help spread the news: x.com/triallofficial/status/1712441092077916338?s=20

Data-informed clinical research: zooming in on external control arms 🔍 Recent advancements in data science & technology have made way for a new virtual counterpart to the control group. These ‘external control arms’ draw data from historical clinical trials or RWD sources like electronic health records. They offer a solution for scenarios where recruiting a control arm is not feasible, for instance in the case of rare or life-threatening conditions with no or inadequate treatment options. Research suggests external control arms can reduce sample size requirements by up to 20-50%, leading to significant cost-savings while also speeding up recruitment timelines. In this article, we cover FDA guidance on externally controlled trials and 2 biopharma companies that successfully applied this approach. 👉 Link: triall.io/articles/beyond-randomised-controlled-trials-how-external-control-arms-could-change-the-game 🗣 Help spread the news: x.com/triallofficial/status/1712441092077916338?s=20