A Gift That Keeps Giving: The Importance Of A Clinical Registry
July 16, 2018
As defined by Merriam-Webster, the medical definition of a registry is “a place where data, records, or laboratory samples are kept and usually are made available for research or comparative study”. These clinical registries are created through a process of organized recording of information typically obtained through observational methods. This is one of the major differences between registry studies and clinical trials. Clinical trials follow a pre-defined protocol which is generally interventional in nature and has been developed to answer specific questions which have been formulated beforehand, whereas registries collect data generated through the course of routine standard-of-care practices and the data is subsequently analyzed on an ongoing basis to investigate outcomes, patterns and trends. Both types of studies are very important in maintaining the iterative learning process that traverses the spectrum from research to practice and back.
Despite the differences between registries and trials, there are also great similarities in the way they are managed. The first step in setting up a registry is defining the area of interest and the relevant sources that will provide this information. For example, in case of a patient registry, the appropriate patient population is identified as well as the data variables to be collected. These variables may be gathered from Electronic Medical Records, Laboratory systems, Pathology reports, surveys, and so on. Healthcare professionals who are interested in participating in the registry are recruited for the data collection process. Due care should be given to the process of capturing, sharing and making data available for ongoing analysis. Those opting for the easy option of using spreadsheets or other such document driven approaches find that subsequent sharing of information, analysis and collaboration among participating professionals can become a messy business. On the other hand, not all registries require a complex technology platform that requires a lot of time and effort to set up and can be quite expensive to implement and maintain. A versatile, cost-efficient and easy to setup platform that is built from the ground up to facilitate collaboration, goes a long way in ensuring a strong foundation for registry data collection, sharing and analysis.
Registries are of many types and focus on topics ranging from patients and related aspects such as specific conditions, diseases, procedures, or events; to areas such as biospecimens, molecules, devices, and others. The data to be collected is carefully thought through early in the process but is often expanded upon, or refined down, as registry participants gain greater insight into their data. As the data pool increases, it allows professionals to learn from findings such as varying patient response to different treatments; enables them to compare effectiveness of procedures based on a variety of factors; assists them in uncovering patterns of usage across sites; facilitates the creation of tissue and data banks that can be utilized for future research projects; helps in monitoring the safety of drugs and devices; and many other such use cases that provide tremendous value to all stakeholders – not only for our current explorations but also for the purpose of setting up a robust foundation for the future and for questions that are yet to be formulated in our minds.