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Opinion: Synthetic control arms can save time and money in clinical trials

Synthetic control arms aren't the solution to all of the challenges facing randomized trials, but they represent a great way for drug development companies to start using real-world evidence.

Among the many vexing issues faced by companies that conduct clinical trials, at least two of them — the large number of participants needed for trials and participants’ fears they will be end up getting a placebo — can be eased by using an innovative approach to collecting comparison data called synthetic control arms.

With the skyrocketing cost of clinical trials, the proliferation of digital data, and a new FDA commitment to considering real-world data in regulatory decision making, it’s the right time to begin using synthetic control arms. Medical product development is at the brink of a new age of evidence generation, an environment that’s ripe for disruption. The next step requires risk taking, not something this industry is known for.

Synthetic control arms

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