Phones, Internet, and Watches, Oh My!

How Technology Has Helped Us Conduct Decentralized Clinical Trials to Support Real-World Evidence

Vagner Raso, Ph.D.

Vagner Raso, Ph.D.

  • July, 2021

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.

Vagner Raso, Ph.D.

Vagner holds a PhD in experimental pathophysiology from the University of Sao Paulo Medical School. He acquired experience in pharmaceutical companies, medical schools, and hospitals through cross-functional roles in clinical research, medical affairs, and teaching spanning various therapeutic areas. His experience has provided him with evidence-based reasoning, critical thinking skills, and an accurate interpretation of clinical and medical processes. Vagner applies his passion for pathophysiology, research methods, and statistics to educational strategies to support visually appealing storytelling and state-of-the-art materials for SMi Source and SMi Trial.

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