Challenges and opportunities in synthetic clinical trials

Of the many changes coming to clinical trials, one of the biggest potential paradigm shifts on the horizon is the elimination of placebo groups in some trials in favour of synthetic controls drawn from historic data. In theory, this shift in methodology should allow more patients access to life-saving treatments and save trial sponsors money without compromising data integrity. But the devil is in the details, and implementing this kind of trial, getting the right data, and getting regulators to sign off are all serious challenges.

In today’s episode, Web Sun, president and co-founder of Komodo Health, and Tracy Mayne, SVP regulatory and life sciences research at Slipstream IT, talk about this trend, where the industry is now, and what they’re doing to move it along.

Sun and Mayne talk about what we mean when we talk about real-world data: Where is this data and what’s its quality? How can it be made to function in a clinical trial? They discuss some of the hurdles involved in getting the FDA to accept conclusions from synthetic data, and some of the steps companies need to take to create robust data while protecting patient privacy, as well.

They also get into some of the larger ethical questions around using placebos when synthetic trial data is available. That’s just the tip of the iceberg in this fascinating conversation about the future of clinical research.

You can listen to episode 125 of the pharmaphorum podcast in the player below, download the episode to your computer, or find it - and subscribe to the rest of the series - in iTunes, Spotify, Stitcher, and Podbean.