Traditional clinical trials have rigorous protocols and procedures, which may limit whether findings can be applicable to real-world scenarios. Patients may respond differently to therapies when life events occur simultaneously with medical treatments. Daily life provides insights about interrelationships among diseases, drugs, and therapies that are not usually observed in traditional clinical trials.
These days, patients can be continuously monitored from their homes through cell phones, the internet, and watches. Phone or video calls, text messages, and internet-based strategies are customized according to study protocols and rapidly delivered. Electronic diaries and wearables provide information about adverse events, eating habits, and vital signs. Supporting resources, such as videos, help patients accurately report treatment responses, outcomes, and behaviors to ensure data quality. Patients may feel more comfortable to express their feelings and perceptions about treatments, and the respective ramifications of such treatments, in their lives. Staff have easy access to online training materials that can be revised at any time to decrease the risk of learning gaps. Investigators have timely tools for the identification, monitoring, and management of protocol-related risk areas. Staff and investigators can promptly recognize deviations that limit study findings.
Decentralized clinical trials are more feasible and cost-effective. They can be rapidly conducted to accelerate device and drug development and help us understand factors involved with patients' responsiveness that allow us to discover more tolerable and effective treatments in real-world scenarios. Decentralized clinical trials may be one of the most important strategies for the advancement of investigational devices and drugs, even more so when a pandemic, such as COVID-19, hits the world. It is a privilege to be a part of an innovative team that develops tools to support faster discoveries that ultimately improve a patient's quality of life.