The primary purpose of registry studies has traditionally been to collect data to better understand long-term trends in specific populations. This type of study – which now totals approximately 20 percent of registered studies – provides information or describes events and patterns, and often leads to hypotheses about a specific patient population. As a type of observational research, a typical registry study records the outcomes using real-world data after an intervention has occurred.
For example, a registry could be used to study the long term impact of osseointegrated prostheses for amputees, comparing implant designs, surgical techniques, and rehabilitation protocols.
It’s tempting to think there is only one difference between registry studies and clinical studies: clinical studies are investigational and registry studies are observational. In practice, it’s more complex. In OpenClinica’s work with clients on registry studies, we have identified eight distinctions between registry and clinical studies.
How Registry Studies Differ from Clinical Trials
- Real-World Data: Registry studies typically utilize real-world data collected from routine clinical practice or observational settings, rather than data collected specifically for research purposes. This allows researchers to understand how treatments or interventions perform in a real-world setting outside the controlled environment of clinical trials.
- Large Sample Sizes: Since these studies often collect data from a wide range of sources, they can often include large sample sizes, providing a more comprehensive understanding of the outcomes and effects of particular treatments or interventions.
- Longitudinal Data: Registry studies often collect data over extended periods, allowing researchers to track outcomes and evaluate the long-term effects of interventions or treatments.
- Diverse Populations: They can include diverse populations, reflecting the broader patient population encountered in clinical practice. This diversity can enhance the generalizability of study findings.
- Exploratory Nature: Registry studies are often exploratory in nature, aiming to generate hypotheses or insights rather than test specific hypotheses. They can identify patterns, associations, and trends that may warrant further investigation in controlled clinical trials.
- Cost-Effectiveness: Registry studies can be more cost-effective compared to conducting large-scale clinical trials, as they utilize existing data sources and infrastructure, such as EMRs and EHRs.
- Effectiveness and Safety: They are valuable for assessing the effectiveness and safety of treatments or interventions in real-world settings, complementing the efficacy data obtained from controlled clinical trials.
- Post-Market Surveillance: Registry studies are often used for post-market surveillance of drugs, devices, or interventions to monitor their safety and effectiveness after they have been approved and are in widespread use. For example, Novo Nordisk created a pregnancy registry to monitor pregnancy outcomes in women exposed to semaglutide (Wegovy) during pregnancy.
How OpenClinica Helps Solve these Unique Challenges
OpenClinica’s comprehensive suite of clinical research software solutions solve the unique challenges of registry studies. Our solutions are designed to work independently or in concert with each other.
OpenClinica Unite™, our EHR eSource solution, automates source data acquisition from patient medical record systems (EHRs and EMRs) to registry databases. In other words, researchers can leverage real-world data by automatically tapping pre-existing sources of data. The automatic ingestion of data is critical with the larger study populations typical of registry studies. Unite also eliminates high-risk manual data entry and the resulting data transcription errors.
Unite is easy to implement and scales with ease and adaptable as registry design evolves over time. With Unite, registry studies are able to normalize data and maintain consistency across study iterations that may evolve in a 20- or 40-year study, while supporting substudies.
OpenClinica Share™ enables patient-level data capture with single-click mobile sharing of health record data directly to a registry study. A mobile app connects to a participant’s various healthcare providers, which means a study can query all of the providers to identify data to meet the study needs, and seamlessly transfer a copy of the data to the study database.
OpenClinica Participate™, our ePRO solution, supports registry studies with patient surveys, diaries, e.g., food or sleep, quality of life questionnaires and more. It also helps keep participants engaged in a two or three decade study and enables data transmission anytime, anywhere, and from any device.
OpenClinica’s data transformation module converts messy or granular data, e.g., a FitBit or a continuous data diagnostic instrument that takes a reading every six seconds, into a format that is ingestible by the study. For example, our data pipelines can automatically restructure continuous data into a low and high mark for each 24-hour period.
OpenClinica’s solutions are designed to be self-serve. We put a premium on excellent user experience and usability, which is even more critical with registry studies. Data may be entered as infrequently as once a year, meaning training cannot be a prerequisite to using the software.
OpenClinica solutions are imminently scalable. We’ve run studies with tens of thousands and hundreds of thousands of patients. Our automated data pipelines connect and unify third-party data sources, enabling ready ingestion of study data. Scalability and automation are even more critical as the number of patients in the study grows. They also help to reduce costs over the life of a registry study.
To learn more about how OpenClinica can support your registry study, contact us today!