The COVID-19 pandemic is forcing everyone in health care to ask what clinical trials look like when in-person observation is not possible. How does critical research continue when the daily lives of trial participants have fundamentally changed, and their interaction with traditional clinical settings is itself a safety risk?
On March 18th, the FDA released guidance encouraging trial sponsors to adapt their ongoing studies via technology and virtual alternatives to maintain patient safety and trial integrity. The agency has encouraged sponsors to collaborate with them on protocol modifications, including the use of virtual assessments, to enable continuity of efficacy measurements. Given this guidance, many biopharma companies are planning to virtualize upcoming studies while establishing remote monitoring of patients in existing trials for safety reasons. We fully appreciate how hard this is.
At Evidation, measuring patient status and health outcomes outside brick and mortar clinic walls has long been our priority and central to our mission. We have been conducting decentralized, virtual research for years, enabling continuous collection of permissioned data that measures the daily life of individuals with various conditions, both on and off therapy. We have deep expertise in conducting virtual research end-to-end, in all sorts of “free living” conditions: from assessing cognitive impairment severity via consumer-grade multimodal sensor streams to running nationwide RCTs of digital intervention impact on vaccination rates and outcomes during active flu seasons.
Along the way, we’ve learned a lot about what makes virtual trials go well (or not so well), and we’re keen to share lessons learned and best practices as research sponsors think about how to adapt to a changing environment. In that spirit, here is a list of Evidation’s top five things to remember in virtual trials and remote monitoring of study participants:
Build foundational trust. Sponsors should trust that participants are able and willing to conduct study activities outside of a physical site, while staying engaged throughout the study period. Participants’ trust is earned by delivering a person-centered experience, maintaining data privacy and security, and providing robust support.
Think participant first, technology second. Optimize the participant experience for a self-service model and include technology when it enables measurement of daily function in ways not possible with traditional, clinic-based studies. Don’t over-engineer the virtual components of a study if they don’t measure meaningful outcomes or reduce participant burden.
Obsess over data integrity and quality. Technology systems can enable high fidelity data collection and mitigate reporting errors in a compliant environment. However, smart study design and execution can ensure both integrity and quality of patient-reported data, remote data collection, and digital measures.
Select the best devices for the task at hand. Selecting the right devices or sensors to measure specific outcomes at the right frequency is only half the battle. Does the vendor’s interface enable easy data transfer? Are the devices easily provisioned and usable by the target demographic? Carefully considered device selection can prevent launch delays and operational challenges.
Deploy an agile operational team. Embed automated, operational checkpoints and participant support experts to alert you when things are not going as planned. There is simply no substitute for an agile team that can quickly troubleshoot and implement new systems and processes to resolve issues.
Every corner of the health care ecosystem is in a mode of adaptation right now—whether in the medical product supply chain, in the ERs, hospitals, and primary care offices that are caring for growing numbers in need, or in the countless ongoing clinical studies evaluating new solutions for patients. Hopefully, many of these trials will be able to adapt protocols and operations to continue in the face of the COVID19 pandemic to the benefit of patients around the world. At Evidation, our entire team stands ready and willing to do whatever we can to help.