Subject non-compliance with clinical trial requirements can lead to invalid data, false-negative results, and inaccurate dosage recommendations. Investigators and subjects generate barriers to compliance, and the reasons usually involve poor comprehension, communication, and/or follow-up. As mobile electronic devices have become ubiquitous, they have led to significant changes in individual behavior, including the expectation of constant communication and an increased comfort in sharing personal behavioral information. The use and integration of these same technologies in clinical trials provide the opportunity for recording and assessing subject compliance as it is happening rather than retrospectively. The result will be the establishment of subject compliance as an electronic patient-reported outcome.
Disclosure The author is CEO of Medicus Research LLC and Systemedicus Inc.
Correspondence: jay.udani@medicusresearch.com