For years, randomized controlled trials (RCT) have been the gold standard for evaluating new medical treatments and pharmaceuticals in cardiology—but recently, that has started to change.
That’s partly because a true RCT is not always practical. A true placebo can be difficult or impossible to set up, especially when the study involves an invasive treatment. Or utilizing a placebo might be unethical, such as when studying a life-threatening illness. In other cases, it might simply be difficult to recruit appropriate trial participants.
Even in the absence of these obstacles, though, RCTs can have significant drawbacks. In the current healthcare ecosystem, clinical trials are generally disconnected from healthcare delivery, creating a barrier to participation for both patients and physicians. RCTs also tend to be expensive, both in terms of time and money, creating a burden for trial sites, sponsors, and patients alike.
Perhaps most importantly, the results of clinical trials cannot always be extrapolated to the larger medical community. RCTs usually have narrow inclusion and exclusion criteria, which means RCT patients are not always representative of the population of interest. There is also the concern that, as RCTs are performed in highly controlled environments under artificial experimental conditions, it may be difficult to generalize the treatment to real world settings. These factors reduce significantly the generalizability and external validity of trial results.
Given these drawbacks, plus the growing availability of digital health data and technology, the focus of cardiology research is shifting more and more to using Real World Evidence (RWE) in place of RCTs. Currently, the predominant data sources for RWE are electronic health records, which capture data as part of routine clinical care. They are frequently used to generate Real World Data (RWD), which are then analyzed to produce RWE.
However, not all RWD is created equal—which is why the Veradigm Network is such a valuable asset for cardiology researchers.
The Veradigm Network features a dynamic community of companies working together to provide advanced insights, technology, and data-driven solutions. Its broad scope and depth of resources allows solutions to be configurable to your specific needs. Through its significant healthcare provider base, the Veradigm Network provides life science and health plan organizations unique access to de-identified patient data, provider connectivity and analytics at scale.
Among other benefits, the Veradigm Network:
Veradigm’s unique combination of offerings, combined with our large healthcare provider footprint, is the reason so many leading Life Sciences companies choose to work with the Veradigm Network.
One way Life Sciences companies can tap into the power of the Veradigm Network is through Veradigm’s Real World Data Solutions.
When RWD are sourced from disparate EHRs, administrative claims databases, clinical data registries, and other siloed sources, the resulting data are often fragmented and difficult to work with. Your teams can’t afford to waste their valuable time and resources with messy, inconsistent, and cumbersome RWD.
Unlike these data sets, Veradigm’s Real World Data Solutions are purpose-built for research. They combine multiple EHR data sources within the Veradigm Network and through collaboration with other EHR providers to provide streamlined access to over de-identified, ambulatory patient records.
Veradigm RWD offers a variety of RWD solutions designed to fit your specific needs. You can access cardiology-specific cohorts of data or cohorts specific to other therapeutic areas. These data sets are not limited by payer or payment type and include a wide range of practices to provide patients from a broad range of backgrounds.
Veradigm RWD are also unique in utilizing standardized definitions across all included EHRs. This facilitates patient linking between providers as well as facilitates linking to other data types. With Veradigm’s RWD sets, you can:
In addition, Veradigm’s data sets include data not commonly found in administrative claims data. Researchers frequently wish to examine the relationship between heart failure and patient factors not generally found in administrative claims data, such as obesity as measured by BMI. Veradigm’s data sets are rich in data variety because they utilize data enrichment services, such as Natural Language Processing (NLP), to extract information from unstructured data sources (e.g., clinical notes.) This significantly improves data availability.
Another way Life Sciences companies can tap into the Veradigm Network is through use of the Veradigm Cardiology Registry (formerly the PINNACLE Registry). The Veradigm Cardiology Registry is operated in partnership with the American College of Cardiology, a 52,000-member organization dedicated to improving cardiac health in the United States.
The Veradigm Cardiology Registry collects data on patients with coronary artery disease, hypertension, heart failure, and atrial fibrillation. These data provide a comprehensive, longitudinal view of the real world presentation, progression, management, and outcomes of patients with cardiovascular disease as they receive care and treatment from multidisciplinary teams. Curated data are collected from a cross-sectional, geographically diverse patient population. The registry also enrolls practices from multiple specialties, including:
Data collected include demographic information as well as the Program Metrics endorsed by the ACC/American Heart Association Task Force on Performance Measures.
However, the Veradigm Cardiology Registry is not just another cardiology data set: It’s another powerful tool for communicating with cardiology patients and their physicians, to recruit them to participate in your cardiovascular studies. The Veradigm Cardiology Registry is cardiology’s largest combined cardiovascular database, with more than 100 million patient encounters. It also leverages Veradigm’s extensive network of specialists and primary care providers on Veradigm and Practice Fusion EHRs to make research opportunities available to patients and physicians, giving them greater opportunities to participate in cardiovascular research. It provides researchers with the ability to conduct site and patient feasibility prior to study initiation, which can decrease timelines for study start-up, site activation, and patient enrollment.
If your research focus is cardiology, the Veradigm Network can be a powerful tool for your team. The Veradigm Cardiology Registry can supply you with access to the world’s largest combined cardiovascular database, with over 100 million patient encounters, streamlining your search for research cohorts and assisting with data collection. Alternatively, both the registry and Veradigm’s Real World Data Solutions can provide you with curated RWD customized to your specific research needs and therapeutic area of interest.
For more information on how we can help you meet your goals, or for a demonstration, contact us today.