Front and center with the COVID-19 pandemic era is this question: How can we enable research to move forward while keeping patients who participate in studies and clinical trials safe? This requires minimizing exposure to the coronavirus.
Continuing Studies and Clinical Trials Remotely
These public health concerns have expedited a shift in paradigm to support decentralized clinical trials that enable data collection both at the clinical site and remotely—at a patient’s home. This hybrid approach would encourage enrollment of more diverse patient populations within community settings, which would generate information more representative of the real world.
Benefits of Decentralized Clinical Trials
These initiatives are particularly important in assessing new cancer treatments and rare disease therapies affecting patient populations. They can help assess real world endpoints, such as time to treatment discontinuation and tumor mutational burden, which helps to identify cancer patients more likely to respond to immunotherapy and thus provides deeper datasets that can be used as a decision aid by those treating patients.
However, to successfully shift to this new paradigm, we must overcome a challenge: appropriately integrating digital technology in clinical trials and leveraging patient-centered disease registries into a single platform.
Pivoting When the Health Eco-System Changes
Such a registry must be designed by clinical epidemiologists and data scientists who work alongside clinical drug development and include healthcare IT experts. This team of specialists will have an understanding of the global regulatory needs and data standards to help define the data specification to be captured across diseases, organizations and communities, with an aim to foster global alliance. An interdisciplinary team with both the clinical and technical know-how will be able to create a relevant yet sophisticated and secure architecture that meets regulatory and data governance requirements of all stakeholders.
Medicine and science are not static, and neither is a well-designed registry. The platform should provide the ability to evolve as analysis of evidence suggests, for example, when study protocols are changed, new participants recruited, new data variables added, new endpoints chosen, etc. A longitudinal registry is a living and growing body of data.
Consider the real-world example of the impact of COVID-19. Can a registry implement additional COVID-19 questionnaires and acutely relevant data in an existing registry or into a clinical trial? This would enable participants of decentralized clinical trials to provide feedback on the impact of COVID-19 on their immunocompromised status, giving providers better mechanisms to monitor those at risk. This is something we’ve implemented, and we’ve been able to help our clients adapt and quickly pivot to address the changing dynamics SARSCov2 has caused on access, treatment and care.
healthie® & Atom5™: A Platform Built for Decentralized Clinical Trials
Pulse Infoframe and Aparito have developed a registry that meets all of these specifications. In addition, the healthie platform supports patient reported outcomes measures, disease specific data (physical exams, lab data, etc.) and disease natural history, which increases not only the richness of the data but the quality as well. The platform also applies the latest global data mapping standards, including Observational Medical Outcomes Partnership (OMOP) and mCode, to facilitate ongoing real world evidence research and analytics. And, of course, it supports decentralized data collection.
COVID-19 has changed the way clinical trials can run if they are to continue. Using a registry that can pivot when the paradigm has changed so drastically will help keep clinical trials going so that patients awaiting the outcomes of these trials needn’t wait even longer.