Frequently Asked Questions
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General
What is Real-World Clinical Data (RWCD)?
RWCD refers to data collected during routine healthcare delivery, rather than in controlled clinical trial settings. Common sources include electronic health records (EHRs), claims and billing data, patient registries, wearable devices, mobile health applications, and patient-reported outcomes (PROs). Social determinants of health (SDOH) data can also be a source.
Why is RWCD important?
RWCD provides insights into device performance across diverse populations and real-world conditions, addressing many limitations of traditional clinical trials. It offers a more comprehensive, actionable, and timely understanding of clinical practices and outcomes.
What is Real-World Evidence (RWE)?
Real-world evidence is evidence regarding the usage and potential benefits or risks of a medical product derived from an analysis of RWCD.
FDA Regulatory Pathways and RWCD
What are the main FDA regulatory pathways for medical devices?
The FDA employs two primary pathways for medical device approvals: Premarket Approval (PMA) for Class III devices and 510(k) Clearance for Class II devices.
What is Premarket Approval (PMA)?
PMA is the most stringent pathway, required for Class III devices. PMA submissions must include robust clinical data proving the device’s safety and efficacy.
What is 510(k) Clearance?
This pathway is for Class II devices, allowing manufacturers to demonstrate that their device is substantially equivalent to an already marketed predicate device.
How does RWCD play a role in PMA submissions?
RWCD can complement or, in some cases, substitute traditional clinical trial data by increasing representativeness, providing longitudinal data, and enhancing efficiency. Case studies show RWCD being used to secure PMA approval by demonstrating superior outcomes in a real-world setting and to validate safety and performance, supplementing limited RCT evidence.
How is RWCD used in 510(k) submissions?
RWCD can demonstrate real-world performance parity with the predicate device, highlight unique benefits such as improved usability or durability, and address FDA concerns about specific patient populations or use cases. Case studies show RWCD being used to demonstrate equivalent diagnostic accuracy and to validate usability and safety.
What is post market surveillance?
In addition to premarket submissions, the FDA mandates post market surveillance studies under Section 522 of the FDCA for certain devices to monitor long-term safety and effectiveness.
How is RWCD used in post market surveillance?
RWCD enables manufacturers to monitor rare adverse events using large-scale datasets, evaluate long-term performance and safety, and identify off-label use patterns and associated risks. RWCD can be used to detect late-stage complications and to monitor pediatric outcomes, satisfying Section 522 requirements.
The Twenty-First Century Cures Act
What is the Twenty-First Century Cures Act?
The Twenty-First Century Cures Act, enacted in 2016, was designed to accelerate medical innovation and improve patient access to safe and effective devices. A key aspect of the Act is its emphasis on using real-world evidence (RWE) to support regulatory decisions, which has paved the way for broader adoption of RWCD in medical device approvals.
How does the Twenty-First Century Cures Act influence RWCD adoption?
The Act encourages the use of RWE for demonstrating device safety and efficacy, streamlines clinical trial designs by incorporating real-world data, and enhances patient engagement through the integration of PROs and other RWCD sources. The Act requires the FDA to evaluate how RWE can be used to support new indications for approved devices and meet requirements for post market surveillance and ongoing safety monitoring.
Data Sources and Analytical Techniques
What is Real-World Clinical Data (RWCD)?
RWCD refers to data collected during routine healthcare delivery, rather than in controlled clinical trial settings. Common sources include electronic health records (EHRs), claims and billing data, patient registries, wearable devices, mobile health applications, and patient-reported outcomes (PROs). Social determinants of health (SDOH) data can also be a source.
Why is RWCD important?
RWCD provides insights into device performance across diverse populations and real-world conditions, addressing many limitations of traditional clinical trials. It offers a more comprehensive, actionable, and timely understanding of clinical practices and outcomes.
What is Real-World Evidence (RWE)?
Real-world evidence is evidence regarding the usage and potential benefits or risks of a medical product derived from an analysis of RWCD.
Strategies for Manufacturers to Harness RWCD
What is Real-World Clinical Data (RWCD)?
RWCD refers to data collected during routine healthcare delivery, rather than in controlled clinical trial settings. Common sources include electronic health records (EHRs), claims and billing data, patient registries, wearable devices, mobile health applications, and patient-reported outcomes (PROs). Social determinants of health (SDOH) data can also be a source.
Why is RWCD important?
RWCD provides insights into device performance across diverse populations and real-world conditions, addressing many limitations of traditional clinical trials. It offers a more comprehensive, actionable, and timely understanding of clinical practices and outcomes.
What is Real-World Evidence (RWE)?
Real-world evidence is evidence regarding the usage and potential benefits or risks of a medical product derived from an analysis of RWCD.
Emerging Technologies and Future Trends
What is Real-World Clinical Data (RWCD)?
RWCD refers to data collected during routine healthcare delivery, rather than in controlled clinical trial settings. Common sources include electronic health records (EHRs), claims and billing data, patient registries, wearable devices, mobile health applications, and patient-reported outcomes (PROs). Social determinants of health (SDOH) data can also be a source.
Why is RWCD important?
RWCD provides insights into device performance across diverse populations and real-world conditions, addressing many limitations of traditional clinical trials. It offers a more comprehensive, actionable, and timely understanding of clinical practices and outcomes.
What is Real-World Evidence (RWE)?
Real-world evidence is evidence regarding the usage and potential benefits or risks of a medical product derived from an analysis of RWCD.
Lumina RWE and RWCD in Action
What is Real-World Clinical Data (RWCD)?
RWCD refers to data collected during routine healthcare delivery, rather than in controlled clinical trial settings. Common sources include electronic health records (EHRs), claims and billing data, patient registries, wearable devices, mobile health applications, and patient-reported outcomes (PROs). Social determinants of health (SDOH) data can also be a source.
Why is RWCD important?
RWCD provides insights into device performance across diverse populations and real-world conditions, addressing many limitations of traditional clinical trials. It offers a more comprehensive, actionable, and timely understanding of clinical practices and outcomes.
What is Real-World Evidence (RWE)?
Real-world evidence is evidence regarding the usage and potential benefits or risks of a medical product derived from an analysis of RWCD.