Like a Category 5 hurricane, COVID-19 has uprooted traditional clinical trial methods to clear space for emerging models and practices to grow and flourish. Three related and complementary trends will have a profound and lasting impact.
- The shift to virtual/decentralized clinical trials. The popularity of decentralized clinical trials (DCTs) skyrocketed following the nationwide lockdown last March. With safety concerns a top priority, the FDA encouraged researchers to consider alternatives for patient assessments and data collection, including virtual visits. Since elements of the DCT model (full or hybrid) enable patient participation from their homes and can be integrated into any clinical trial, DCTs are fast becoming the new normal.
- The increasing utility and acceptance of real-world data. Real-world data (RWD) refers to data relating to patient health status and/or the delivery of health care routinely collected from various sources, including Electronic Data Collection (EDC) systems and patient-generated data from self-reporting tools, mobile devices, wearables or other biosensors. The FDA accelerated this trend with its new program focused on using RWD and real-world evidence (RWE) to support regulatory decision-making, including approval of new indications for approved drugs and biologics. Medical product developers are using RWD and RWE to support clinical trial designs and observational studies to generate innovative, new treatment approaches.
- Widespread adoption of remote patient monitoring. Remote patient monitoring (RPM) can remove barriers (e.g., transportation challenges, time commitments, miscommunications) and allow investigators to track patients’ responses to treatments more easily, effectively and precisely. According to a recent GlobalData report, RPM “witnessed a massive uptake in the life-sciences sector in 2020” and will be among the trends having the greatest impact on the pharma sector in 2021. At Glooko, for example, the use of our remote patient monitoring platform rose 50% and patients’ use of our remote tools increased by 80%.
Rethinking research platforms
These trends will make it easier for patients to participate in clinical trials, which will become more efficient and generate more robust, meaningful data and insights. To capitalize on new opportunities, developers should demand more from their clinical research platforms. As trials move into the real world, these platforms will play an increasingly important role across the entire spectrum of drug development, from informing site selection, trial feasibility, trial design and patient recruitment to monitoring and measuring patient behaviors and safety signals.
With more trials adopting full or hybrid DCT models, managers and investigators can access voluminous, near real-time digital health data. Research platforms should help them manage and mine this treasure trove of information. In addition, these platforms should facilitate data sharing between multiple combinations of trial managers, patients, devices, trial data and EDC systems. Other core functions of a modern research platform might include the following:
- Integrating patient data from multiple sources that investigators can view through a single portal.
- Being device agnostic and patient-friendly so that patients can collect data from their wearables or sensors and easily upload or share this remotely or in the clinic.
- Providing rich sets of RWD, which can be invaluable for researching a wide range of interventions, variables, and specific patient populations.
- Offering sophisticated analytical capabilities to gain insights into patient behaviors.
For a closer look at how modern platforms might be used, here are more examples of currently available platform capabilities and applications that could accelerate the enrollment and execution of clinical trials, expand their reach and generate more valuable information.
Integrating research and care sites
The origins of common clinical trial problems such as low and slow patient recruitment can be traced to a widening separation between clinical trials and clinical practice. The shift to virtual studies is a step forward in closing this gap, especially for sponsors and CROs who take advantage of ready-to-use, patient-centric RPM clinical care platforms. For example, the Glooko platform offers de-identified data for diabetes patients from 7,500 clinics in 29 countries. It enables people with diabetes to remotely share their glucose trends, insulin usage patterns, medication and other data.
Site selection, protocol feasibility and patient recruitment
A research platform that incorporates granular data from many clinical sites can help identify where to target recruitment efforts and establish evidence-based criteria for selecting sites and evaluating protocols. Platforms with large, diverse patient populations and a broad range of sensitive de-identified data can be used to target patient groups with specific characteristics. Observational learnings from diverse datasets also can be used to inform trial design.
Applying Contextual Data
The physiologic data from RPM solutions only tell part of the story. For example, if a patient’s glucose data suggest a low hypoglycemia event, it would be helpful to know her most recent insulin dosing and food intake data and her activities, all of which might shed light on what precipitated the event. By integrating data from multiple sources such as ePRO and patient-reporting tools, a research platform can provide a deeper understanding of how treatment protocols affect patients’ lives.
Leveraging RWD and Clinical Databases
Real world data/real world evidence datasets are being used today to create synthetic control arms and standard-of-care arms to offset the burden and challenge of recruiting trial participants. New deep learning algorithms are using observational data on humans rather than pre-clinical data on animals to speed up hypothesis generation and reduce translational problems. As “digital phenotyping” (establishing profile characteristics based on interactions with digital devices) gains traction, developers can use this to create virtual digital “biomarkers” to interrogate clinical datasets and accelerate learnings.
Enhancing patient engagement and study management
Other key features of a high-performance research platform include the following:
- Customized dashboards that give developers, CROs, administrators and investigators access to a web portal to track enrollment and progress against protocol and monitor outcomes and adverse events.
- Predictive algorithms that allow for early outreach to participants highlighted as “likely to drop out of the study.”
- Tools that fit seamlessly into patients’ lives and day-to-day operations of clinical sites.
- Mobile and web in-app patient engagement tools to improve participant adherence.
In a regulated industry that can be slow to advance, the pandemic has triggered sweeping changes that have forever altered the clinical trial ecosystem. To adapt and thrive, developers and CROs must take full advantage of the ever-expanding capabilities of modern clinical research and clinical care platforms that are particularly well-suited for today’s virtual, digitized healthcare environment.
Dr. Mark Clements is the chief medical officer at Glooko Inc. He is a professor of pediatrics at the University of Missouri-Kansas City School of Medicine, and a pediatric endocrinologist at Children’s Mercy Kansas City, where he serves as director of pediatric endocrine/diabetes clinical research and medical director for the pediatric clinical research unit.
Komathi Stem is a biomedical engineer and chief operating officer at Glooko Inc. She has more than 25 years of experience spanning start-ups to global pharma/biotech companies across multiple therapeutic areas and phases for biologic and small molecule drugs. She has extensive experience in the use of real world data from EHRs, connected devices, and mobile apps to execute virtual and/or decentralized clinical trials and support remote patient monitoring.