Bridging Clinical Efficacy And Real-World Effectiveness In Digital Therapeutics Trials

No matter how conclusive clinical evidence is for medical treatments, developers may struggle to see precisely how their treatment performs in the real world—outside the controlled environment of the clinic or office. Do patients take the medication as expected while immersed in busy schedules? How often do they practice the exercises the therapist prescribes?

Unfortunately, medical treatments proven to work in clinical trials do not always measure up in the real world. According to Simon Makin’s “A smarter way to treat” article, one quarter to one half of the global population doesn’t take medications as recommended. In the U.S., this failure links to up to 125,000 deaths and costs up to $289 billion.¹ The gap between efficacy and effectiveness is a significant issue impacting many.