Brandy Morneau

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.

 Sponsors should continue to deploy technology solutions to help keep patients engaged and increase the quality of study data, while continuing to meet regulatory requirements. Tools such as electronic clinical outcome assessments (eCOAs) are able to help ensure that trials are set up with the patient experience in mind.

 As an industry, we must continuously look to simplify study participation for patients and sites. This includes collecting clinical data remotely without overcomplicating the patient experience and making studies engaging to participate in—even with fewer on-site visits. For example, increasing the utilization of video can help instrument owners to determine appropriate and optimal ways to deliver ratings remotely. It can also help data scientists use analytics tools and in-house algorithms assess the ongoing integrity and consistency of data collected throughout the course of each study. This helps ensure the integrity and validity of clinical assessments without compromising the patient experience.

 The trial design must state clear objectives, set timelines, assign appropriate resources and staff, communicate details and continuously assess associated risks. This will prevent delays and issues during the launch process while also accounting for milestones and mapping out key stakeholders’ involvement throughout the process. It is critical that sponsors and investigators ensure the blueprint for data quality standards remains high, no matter where or how the studies are taking place.

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.

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Brandy Morneau

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