By Sara Gray, Associate, Research & Programs 

The National Health Council and the Duke-Margolis Center for Health Policy continued the introductory series on real-world data (RWD) and real-world evidence (RWE) with a webinar introducing patient registries, which are made up of RWD and often inform RWE studies. Speakers included Robert McBurney, PhD, Chief Research Officer, Accelerated Cure Project for Multiple Sclerosis; and Vanessa Boulanger, MSc, Director of Research Programs, National Organization for Rare Disorders. 

The term “patient registry” is sometimes used interchangeably with clinical registry, disease registry, and outcomes registry. There is no single, standardized, agreed–upon definition as the complexity of registries varies greatly – ranging from simple surveys to sophisticated, linked datasets. The Agency for Healthcare Research and Quality’s (AHRQ) defines patient registries as: 

• An organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves a predetermined scientific, clinical, or policy purpose(s). 
• Compiled to learn about that disease or condition, monitor outcomes and quality of care, or to develop research or therapeutics.  
• May also be referred to as clinical registries, disease registries, and outcomes registries.

Source: AHRQ Effective Health Care Program  

Creating a patient registry, starts with defining its purpose and identifying the patient community and types of RWD that will be collected. Registries can collect information on individuals with a particular disease, follow disease progression, document patient experience and preference, and even can be used as surveillance tools to monitor quality of care and safety.  

To facilitate patient engagement with registries, one must establish trust with communities and involve patients in the development of the registry and corresponding studies. This step is vital to achieving diversity and representativeness in a registry population. 

Dr. McBurney followed his presentation with a registry case example, the iConquer MS patient–powered research network. This registry was created in 2014 and has over 7,000 participants, all either patients or caregivers affected by MS. This network has a variety of functions — all run by patients, including a governance board, research committee, engagement committee, and others. This network is all about “people plus data, and how that can move research forward.” 

In one example involving that registry, data were collected on the symptoms having the greatest impact on patients’ lives. The top-rated symptoms included fatigue, sleep disturbances, wellbeing, and anxiety. Issues with mobility were ranked lower on the list, but they tend to be most frequently studied in standard clinical research. The symptoms patients ranked with the highest importance are not the ones usually studied in clinical research, highlighting the potential work that can be done and information that can be provided with patient registries.  

These registries have also been used in patient-focused drug development and to inform efforts during the COVID-19 pandemic. Overall, patient registries provide the unique patient perspective and has the potential to benefit research, drug development, and patient experiences.  

View the full webinar here.