16 Sep How remote patient monitoring technology can impact decentralized clinical trials

What is next for decentralized clinical trials (DCTs) after acceleration from COVID-19?

By Tony Fantana; Arthur Combs, MD; and Jiang Li, Applied Clinical Trials

As early as 100 years ago (see photograph of Radio News cover, April 1924) the concept of “decentralized care” seemed just around the corner. Several key elements had to evolve over the past century to make this a reality: the sensors (remote patient monitoring), the telecommunication infrastructure (the Internet), the science, and perhaps most importantly, the buy-in from the medical and patient communities. The COVID-19 pandemic greatly accelerated the latter—to the point where we need to ask: what’s next? What did we learn, and how do we pragmatically move forward?

Depending on how we define them, decentralized clinical trials (DCT) are not new– the concept and early trials with a decentralized design significantly antedated COVID 19. Craig Lipset, clinical research pioneer, cites an internet feasibility study from 2003 and a Boston University patent for “Trials over the Internet” in 2007. But they still are not a singularly defined entity which has led to some confusion around the nomenclature (virtual? hybrid? combinations? site-less?) and execution.

Recently, the Clinical Trials Transformation Initiative (CTTI) guidance defined DCT as trials “in which some or all study assessments or visits are conducted at locations other than the investigator site.” Here, we specifically focus on a portion of this broad spectrum: how technology can enable participation, leading to lower participant burden and better data. We believe this aligns well with the efforts to provide broader access to a more diverse population, which is encouraged by the latest FDA recommendations.

In part, pharmaceutical companies and CROs can conduct viable decentralized drug development trials because of the advent of remote patient monitoring technology, wearable sensors, and electronically gathered data such as ePROs, but also as a result of a more patient centered, real-world data focus. How those trials are established, conducted, and validated evolved significantly under the pressure of the COVID-19 pandemic.The question now is what happens next? What have we learned (both pre- and post-COVID) and how can we put it to practical use? How do the benefits to participant burden and cohort diversity balance with the hard endpoints required to establish safety and efficacy for new drugs? What study design elements, enabling technology, and next generation data management are required for all stakeholders including patients, investigators, sponsors, society to benefit? Read more …