You just decided to invest a significant portion of your innovation budget to power your clinical trial with new mobile health technology. Now what?
Medidata sponsored a clinical trial to test if mHealth devices and tools could drive better health outcomes in overweight adults with Type 2 diabetes.
The call for Bring Your Own Device (BYOD) for electronic clinical outcome assessments and electronic patient-reported outcomes is at the front of my mind.
In clinical trials, does the patient experience matter? Well of course it does, or does it? Clinical trials are designed to prove the efficacy and safety of treatments and are fundamentally, therefore, data gathering exercises. Study participants are data sources and to preserve the quality/integrity of the data and the statistical power of the study, we treat them as “subjects.”