pharmaphorum May 23, 2024
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...
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