Improving patient adherence can elevate trial results: Sweetch

If a key goal of a clinical study is to predict a drug candidate’s real-world effectiveness, then patient adherence to the regimen at the center of the study is crucial. If patients don’t take a drug as directed, as frequently as required, or they stop taking it altogether, the data won’t measure up.

To learn more about how trial teams can increase adherence, Outsourcing-Pharma checked in with physician Yossi Bahagon, co-founder of Sweetch, a company that uses artificial intelligence, applied behavioral science, and other tools to help increase adherence.

OSP: How does the gap between drugs’ performance in RCTs (randomized controlled trials) and in real-life use hurt pharmaceutical companies’ work?

YB: In general, RCTs are considered the best methodology to explore or examine the efficacy and safety of a medication. That being said, they are bound by various limitations.

First, RCTs must be conducted on a clearly defined patient population within the constraints of a very specific investigational setup. Trials must be performed with patient groups that, for example, fall into a specific age range, share a specific disease profile, or do not have common co-morbidities. Patients in these trials must adhere to a very specific follow-up regimen and are often supported by clinical trial coordinators.

RCTs are designed to measure a very specific outcome, and so they are, by design, very tightly controlled, and therefore an approximation of what one would expect in the real world. By no means are they a true measure of real-world dynamics.

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