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With various COVID-19 vaccine trials underway, a seamless clinical research process has never been more critical.
Clinical trials are the backbone of our healthcare system, facilitating ongoing research that is critical to developing medicines that can improve patient lives. In a climate that now demands social distancing to keep patients safe, we must continue to implement bold new practices to conduct trials because of COVID-19.
Instead of face-to-face clinic visits, a core safety risk mitigation strategy now allows participants to check in remotely and complete their activities using telemedicine and other technologies. While the industry worked quickly to adopt these new protocols, many changes are already widely accepted and expected to continue even after the pandemic subsides. In response to this shift, as an industry, we must focus on leveraging technology and scientific knowledge to help sponsors implement thoughtful and scalable solutions to keep patients engaged and involved in continuing clinical trials. There must be an industry standard showing how trials are designed to set patients up for success. Below, I’ve provided recommendations on guidelines study sponsors should follow in order to keep trials going and patients cared for.
Whether a trial sponsor uses eCOA to collect primary or secondary endpoint data or evaluate a novel endpoint, sacrificing quality is never an option in today’s environment. Technology platforms that make it possible to collect self-assessment data, leverage telemedicine and orchestrate third-party activities (such as courier deliveries and home nurse visits), will facilitate a complete clinical trial experience, even in a remote setting.
Navigating the nuances and complexities of clinical trials enables sponsors and investigators to improve key aspects of clinical research—from planning and startup through closeout—and successfully support trials in the search for COVID-19 treatments and beyond.
Brandy Morneau is a Project Manager at Signant Health