Glossary Term
Real-World Evidence (RWE)
Definition
Real-World Evidence (RWE) refers to the clinical evidence derived from real-world data (RWD) that reflects the use of medical treatments or interventions outside the controlled environment of clinical trials. RWD includes data gathered from various sources such as electronic health records (EHRs), insurance claims, patient registries, and even mobile health apps. RWE is used to evaluate the effectiveness, safety, and value of medical treatments, devices, or therapies in a broader, more diverse patient population, reflecting everyday clinical practice.
Relevance to the MedTech Industry
Real-World Evidence is gathered to provide insight into how medical treatments or devices perform in routine healthcare settings. Unlike clinical trials, which focus on carefully controlled and specific patient populations, RWE helps assess the treatment's impact across a wider range of real-life conditions, patient demographics, and treatment patterns. This can inform regulatory decision-making, clinical guidelines, reimbursement policies, and patient care strategies.
Additional Information & Related Terms
Common Sources of Real-World Evidence
Electronic Health Records:
EHRs provide a continuous stream of data about patient diagnoses, treatments, and outcomes, which can be used to assess the long-term effects of a medical device on a broader population.
Patient Registries:
Patient registries are collections of data that track the outcomes of patients with specific conditions or who have undergone certain treatments or interventions. These registries are valuable sources of RWE, providing longitudinal data on patient experiences and outcomes.
Example: A national registry for patients who have received knee replacements may provide RWE on the long-term durability and complications associated with different types of implants.
Insurance Claims Data:
Insurance claims data provides insights into healthcare utilization patterns, including diagnosis, treatments, and outcomes. These data can be used to assess the real-world cost-effectiveness of medical devices and interventions.
Example: Claims data can be analyzed to assess the rate of complications or follow-up procedures associated with a particular medical device, such as a spinal fusion device.
Mobile Health and Wearables:
The rise of mobile health apps and wearable devices provides a new source of RWD. These devices allow for continuous monitoring of patient health, such as heart rate, glucose levels, or physical activity, providing rich data on patient behavior and outcomes.
Example: Wearable devices can provide RWE on how a new cardiac implant is performing by tracking patient activity levels, heart function, and adherence to prescribed treatments over time.
Examples of Real-World Evidence Applications
Post-Market Surveillance:
RWE can be used to monitor the long-term performance of medical devices once they are in widespread use. This allows manufacturers and regulators to identify rare adverse events, unforeseen complications, or long-term outcomes not captured in pre-market studies.
Example: Real-world data from a national registry helps track the long-term failure rates of hip replacement devices, highlighting potential issues with a particular model that did not appear in clinical trials.
Cost-Effectiveness and Value-Based Healthcare:
RWE can be used to assess the cost-effectiveness of medical devices, taking into account factors like treatment adherence, complications, hospital readmissions, and quality of life. This helps inform pricing and reimbursement decisions.
Example: Data from insurance claims and patient registries provides insight into the cost-effectiveness of a new diabetes management device by evaluating hospital admissions and medication savings over time.
Clinical Decision Support and Personalized Medicine:
RWE can be leveraged to inform clinical decision-making by providing insights into how treatments or devices perform across different patient populations. This can help identify the most effective options for individual patients based on real-world outcomes.
Example: RWE is used to tailor the selection of medical devices for patients with specific comorbidities, ensuring that interventions align with the best available evidence from both clinical trials and real-world experience.
Patient and Provider Education:
RWE can help educate patients and healthcare providers about the potential benefits and risks of different medical devices. It provides evidence of how devices perform in a broader, more diverse population, helping inform treatment choices.
Example: Real-world data showing improved mobility and pain relief after the use of a new knee implant is used to educate both patients and orthopedic surgeons on its long-term benefits.
Related Terms
Clinical Trial: A controlled experiment used to evaluate the safety and effectiveness of medical treatments, devices, or interventions, often used as a comparison to RWE.
Post-Market Surveillance: The process of monitoring a medical device after it has been released to the market, using RWE to track safety, effectiveness, and long-term performance.
Regulatory Science: A field of study focused on developing and applying new methods and data sources (including RWE) to assess the safety, efficacy, and quality of medical products.
Patient Registries: Databases that track outcomes for patients with specific diseases or conditions, often used to generate RWE about treatments and devices.