Real-world data means health information collected outside of regular clinical trials. It comes from sources like electronic health records (EHRs), insurance claims, pharmacy records, lab reports, and patient registries. When this raw data is studied, it creates real-world evidence (RWE). This evidence helps doctors understand diseases better, check how well treatments work, and make healthcare decisions.
In the United States, healthcare produces about 30% of the world’s data. But a lot of this information is stuck in separate systems, so it can’t always be used well. Some big healthcare groups in the U.S. work on putting this data together and studying it to improve patient care. For example, the Premier Applied Sciences’ PINC AI™ Healthcare Database has data from over 240 million different patients. This data comes from 1,100 healthcare places collected for over 20 years. It includes many kinds of data like outpatient visits, pharmacy fills, and payment types. This mix helps researchers analyze both health and financial results.
Using real-world evidence is becoming more important in health research and daily medical care. Clinical trials often have strict rules about who can join. Real-world data covers many different types of patients, even those usually left out of trials. This wide range lets doctors see real patient experiences, treatment effects, and side effects in everyday settings.
For example, Flatiron Health uses real-world data in cancer research. They have more than 4 million de-identified patient records and 1.5 billion data points. Their data covers many types of cancer and detailed genetic markers. Real-world evidence from Flatiron has helped get drugs approved by the FDA, shaped policy decisions, and improved treatment guidelines like when to stop immunotherapy.
Caris Life Sciences studied over 295,000 tumor samples using real-world clinico-genomic data. They found that more than 20 percent of cancer patients qualified for treatments targeting specific genetic markers, no matter where the tumor was. The data also showed differences in treatment results between tumor types. This shows how RWE can help make cancer treatment more personalized and find new uses for therapies beyond original clinical trial cases.
Doctors using these datasets in daily care can make better decisions, find early risks, and match treatments to patient needs. For administrators and IT managers, these insights also help with managing resources, improving patient care, and running health services better.
A big challenge with real-world data is that it comes from many sources with different formats and ways of naming data. Without a standard way to organize it, comparing and studying data from different places is hard and often not reliable.
The Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM) was created to fix this problem. OMOP makes data from many healthcare sources like EHRs, insurance claims, and patient registries look the same. It uses common coding systems like ICD-10, CPT, and LOINC so data becomes consistent and easy to compare.
This standardization is important for making sure real-world evidence is good quality. It helps healthcare groups do strong research, check how well treatments work, and produce evidence that meets government rules. The FDA and European Medicines Agency (EMA) now accept real-world evidence from standardized data for safety checks, approvals, and monitoring after drugs hit the market. Medical practices that use data standards like OMOP can join bigger research projects, compare their work to others, and support care with proven approaches.
For administrators and IT workers, joining these networks gives access to large amounts of data without needing to handle everything themselves. These partnerships help improve clinical research work, patient treatments, and keep up with healthcare changes.
One benefit of using real-world evidence in healthcare is the chance to use artificial intelligence (AI) and automation to make tasks easier. AI can study huge amounts of data quickly and find patterns that people might miss.
For example, machine learning can guess when patients might need to go to the hospital or be discharged. It can also help with planning how many staff members are needed. AI predicts problems like nurse absences, which helps managers adjust schedules to avoid delays and keep care smooth.
Natural language processing (NLP) pulls useful information from notes, lab reports, and imaging results in medical records. This helps make patient profiles more complete and supports better decisions.
Front-office automation tools, such as those from companies like Simbo AI, use AI to improve phone and communication tasks. These tools handle patient calls, schedule appointments, send reminders, and answer questions. This frees up staff to work on more important duties and helps clinics run better while improving patient experience.
For healthcare administrators and IT managers, knowing and using real-world evidence brings real benefits:
This method helps healthcare organizations improve care quality and patient results while managing costs.
The growing amount of real-world healthcare data and better tools to study it are changing how medical practices work in the United States. Using real-world evidence helps improve diagnosis, personalize treatments, streamline operations, and meet regulatory needs.
For medical practice administrators and IT managers, adopting data standards, joining federated data networks, and using AI-driven workflows will be important to get the best results from clinical data in the future.
The webinar series focuses on the digital technologies and data-driven innovations deployed by hospitals, showcasing how healthcare providers can leverage these tools to enhance their processes.
Digitalisation has led to improved operational decision-making through real-world data and AI-driven algorithms, impacting how healthcare is delivered and care pathways are designed.
Electronic health records can predict hospitalisation and discharge, influencing capacity management, patient flows, and decisions regarding triage, admissions, and discharges.
Digital technologies provide real-time visibility into inventory levels, allowing for better planning of orders and reducing waste in supply chain management.
Digital transformation facilitates patient engagement in co-designing care pathways, leading to improved care and higher patient satisfaction.
Currently, 30% of the world’s data is generated by the healthcare sector.
The Outcomes Network aims to address data isolation by collecting and analyzing outcomes of cataract surgeries across multiple hospitals to create clinical insights.
EHDEN focuses on increasing data harmonisation by building a federated data network that standardizes access to the data of 100 million EU citizens.
Standardisation is crucial for fully harnessing data’s potential, encompassing collection, harmonisation, analysis, and deriving real-world insights.
The European Medicines Agency aims to use Real-World Evidence effectively across various regulatory use cases by 2025.