STAT+: Health app companies wrestle with how to design studies to prove treatments work

Should health app makers use sham controls to test their products more rigorously? Some industry leaders say it isn't strictly necessary.

For companies that have spent years developing interactive technologies to help treat disease, the tricky question inevitably comes: How far are you willing to go to prove it works?

Some test their products, sometimes called digital therapeutics, in the most rigorous, and expensive, way. They run a randomized trial with a sham control that mimics everything about a product, except the piece that’s supposed to have therapeutic effect. But many aren’t that aggressive about the evidence — and the message to industry at the DTx East conference in Boston was that the gold standard of research isn’t strictly necessary. If all a company is trying to do is advance their design or show enough progress to raise another funding round, comparing their product to the standard of care or not comparing it to anything at all might suffice.

Continue to STAT+ to read the full story…