Written by: Gerald L. Klein, MD* Michael Fath, PhD* Sukhwant Khanuja, PhD** Roger E. Morgan, MD* MedSurgPI* Carematix Inc**

Introduction

The advent of wireless technology has revolutionized many sectors of healthcare, especially clinical trials and the medical assessment of homebound geriatric patients. Wireless remote patient monitoring (RPM) can enhance the efficiency and effectiveness of decentralized and patient-centric clinical trials. Decentralized clinical trials (DCTs) are studies that are not limited to a geographical region but are conducted through the use of local investigators with telemedicine and remote patient monitoring.[1] RPM allows the expansion of these studies into more remote and diversified populations that are notoriously underrepresented. The FDA has released guidance documents on the conduct of decentralized clinical trials.[2] Clinical research organizations (CROs) now take advantage of both the use of decentralized and hybrid clinical studies which uses a combination of the two. Here, we explore how wireless RPM can improve clinical studies. View the entire article here

[1] Apostolaros M. Babaian D. Corneli Al et al. Legal Regulatory, and Practical Issues to Consider When Adopting Decentralized Clinical Trials: Recommendations From the Clinical Trials Transformation Initiative. Ther Innov Regul Sci 54, 2020: 779-787.

[2] https://www.fda.gov/media/167696/download