Explore everything you need to know about RWE in clinical research, from understanding Real-World Data (RWD) sources to its essential applications in R&D, Market Access, and Regulatory decision-making.
Our FAQs provide a comprehensive overview, covering how RWE informs drug development and supports high-quality healthcare decisions. With Schain Research’s AI-powered insights, companies can leverage RWE to advance drug development, optimize market access strategies, and meet rigorous regulatory standards.
What are RWE and RWD in clinical research?
RWE is derived from RWD collected in routine clinical settings. It includes sources like electronic health records, patient registries, and claims, providing insights into treatment outcomes in real-world populations. This supports R&D by helping identify promising treatments, aids Market Access by demonstrating effectiveness, and informs Regulatory decisions. Explore our RWE services here.
What are examples of RWD?
RWD includes electronic health records, insurance claims, patient registries, and wearables, all of which offer valuable insights for R&D, Market Access, and Regulatory use. For example, registries track treatment adherence, supporting Market Access, while wearables provide patient behavior data, aiding R&D in understanding patient needs. Learn more about our data sources.
How is RWE generated?
Generating RWE involves gathering and analyzing data from multiple real-world sources, such as EHRs, claims databases, and patient registries. Quality checks and advanced analytics ensure the data offers meaningful insights for healthcare decisions. See how we generate RWE across various therapeutic areas.
What is the difference between RWD and RWE?
RWD refers to raw health data collected from everyday clinical settings, such as electronic health records, claims databases, and patient registries. However, RWE is the insight derived from analyzing RWD to inform treatment outcomes, safety, and effectiveness. At Schain Research, with Ciencia Technology, we specialize in transforming RWD into actionable RWE using our advanced EpiX platform. This AI-powered tool allows us to process complex data efficiently, uncovering patterns and insights that help drive evidence-based decisions for drug development and personalized medicine. Discover more about EpiX and our AI capabilities here.
How does RWE differ from randomized controlled trials?
Randomized controlled trials (RCTs) measure efficacy in controlled settings, while RWE captures real-world effectiveness. This provides insights for R&D on broader patient populations, for Market Access to support cost-effectiveness arguments, and for Regulatory assessment of long-term safety.
How is RWE used in clinical practice?
RWE supports personalized treatment strategies in clinical settings by showing how therapies perform in specific populations. It enables providers to make more tailored decisions, enhancing overall patient care.
What are the benefits of RWE in healthcare?
RWE offers a holistic view of treatment landscapes, reflecting the diversity of real-world patient populations. It supports personalized care, optimizes R&D by targeting patient needs, enhances Market Access with value-based arguments, and informs Regulatory bodies of better health outcomes.
How is RWE applied in drug development?
RWE helps identify patient subgroups, assess long-term safety, and evaluate cost-effectiveness, providing essential data for R&D, Market Access, and Regulatory approvals. This enables faster, evidence-based decisions across the drug lifecycle. Explore our services supporting drug development.
How long has RWE been used in drug development, and how has it affected costs?
RWE has gained importance in drug development over the past 20 years, especially with the growth of digital health data. By complementing clinical trials, RWE enables faster, more cost-effective decisions, reducing time to market for new therapies.
What role do regulatory bodies like the FDA, EMA, and others play in RWE?
Regulatory bodies such as the FDA in the U.S., the EMA in Europe, and Health Canada recognize RWE as a valuable addition to clinical trial data, particularly for safety and effectiveness assessments. Institutions like NICE in the UK, NMPA in China, and the PMDA in Japan also integrate RWE into healthcare guidelines and post-market evaluations, helping support evidence-based healthcare worldwide. Schain Research’s RWE solutions help meet the standards of these global agencies, supporting regulatory submissions and healthcare decision-making.
For more information on each agency’s approach to RWE, you can visit:
FDA Real-World Evidence
EMA Real-World Evidence Guidelines
Health Canada Real-World Evidence Framework
NICE Real-World Data Framework
NMPA guiding principles for RWE research
PMDA Real-World Data and Real-World Evidence
RWE regulatory landscapes in Asia-Pacific region
Learn more about Schain Research’s regulatory-grade services here.
How will AI impact RWE and RWD?
AI enables faster, more precise data analysis, transforming RWE for R&D, Market Access, and Regulatory purposes. With AI tools, we deliver insights that drive smarter decisions and uncover valuable patterns across drug development, cost-effectiveness, and compliance. Discover more about EpiX and our AI capabilities here.
How does Schain Research support RWE generation?
Schain Research specializes in RWE solutions for pharma and biotech, offering insights that support decision-making across drug development, market access, and patient outcomes. Our data sourcing and AI-driven analysis expertise empower clients to make evidence-based decisions that drive success. Contact us to learn more about our services.