The 2026 Pillar Guide
Real-World Evidence: The 2026 Guide
Real-world evidence (RWE) is the clinical evidence about a medical product’s use, benefits and risks, drawn from real-world data generated outside conventional randomized trials.
This guide covers what RWE is, how it is used, where the data comes from, and the companies and methods shaping it, ahead of RWE Connect 2026 in Boston.
Free. Instant download. No obligation.
The definition
What Is Real-World Evidence?
RWE has moved from the margins to the centre of drug development and healthcare decision-making. Under the FDA real-world evidence framework, established through the 21st Century Cures Act, it now informs regulatory, payer and clinical decisions worldwide.
Clearing it up
Real-World Data vs Real-World Evidence
The two terms are often used interchangeably, but they are not the same thing. One is the input, the other is the conclusion.
Real-World Data (RWD)
- The raw inputs
- EHR, claims, registries, wearables
- Collected during routine care
- Describes what happened
Real-World Evidence (RWE)
- The analysed output
- Derived from studying RWD
- Answers a clinical or economic question
- Informs a decision
Applications
How Real-World Evidence Is Used
Real-world evidence supports decisions across the product lifecycle, from regulators to payers to the clinic.
Where the data comes from
The Sources Behind Real-World Data
Real-world evidence is only as strong as the data underneath it. These are the main sources.
The state of the field
The State of Real-World Evidence in 2026
Real-world evidence is maturing fast, from a supporting role to a central one. These are the forces defining the field in 2026, and the themes RWE Connect brings together.
Who is in the room
Who Attends RWE Connect 2026
A senior, focused audience of the people who generate and apply real-world evidence.
Seniority is confirmed: 150+ attendees, around 60% at Director or VP level and above. The functional mix shown is indicative; confirmed registration splits are shared with sponsors from the live delegate list.
Glossary
Key Real-World Evidence Terms
Explore
The Real-World Evidence Ecosystem
The companies, data and methods that turn real-world data into decisions. Explore the landscape and meet them in Boston.
Sponsor RWE Connect 2026
Meet the Real-World Evidence Buyers in Boston
RWE Connect 2026 brings 150+ real-world evidence, HEOR and data leaders together, around 60% at Director or VP level and above. Sponsors reach them directly.
RWE Connect 2026
Get the 2026 RWE Pipeline Report
The people, data and methods shaping real-world evidence, in one download. See the landscape ahead of two days in Boston.
- The 2026 RWE vendor and data landscape
- Where the field is heading
- How to take part in RWE Connect 2026
Free. Instant download. No obligation.
Real-World Evidence: Common Questions
What is real-world evidence?
Real-world evidence (RWE) is the clinical evidence about the use, benefits and risks of a medical product, generated by analysing real-world data collected outside conventional randomized controlled trials.
What is the difference between real-world data and real-world evidence?
Real-world data (RWD) is the raw information collected during routine care and daily life, such as electronic health records, claims and registries. Real-world evidence is the analysed output: the clinical or economic conclusions derived from studying that data.
How is real-world evidence used in regulatory decisions?
Under the FDA real-world evidence framework, established through the 21st Century Cures Act, RWE can support certain regulatory decisions including label expansions and post-approval safety commitments, alongside its wide use in HEOR, market access and pharmacovigilance.
What data sources are used for real-world evidence?
Electronic health records, administrative claims, disease and product registries, tokenized and linked data, genomic and molecular data, and patient-generated and wearable data.
Is real-world evidence accepted by the FDA?
Yes. The FDA maintains a formal real-world evidence framework and has used RWE to support regulatory decisions. Acceptance depends on the quality, relevance and reliability of the underlying data and study design.
What is RWE Connect 2026?
RWE Connect 2026 is a two-day real-world evidence summit in Boston bringing together the RWE, HEOR, data and analytics leaders who generate and apply real-world evidence, with 40+ speakers and 150+ attendees.
When and where is RWE Connect 2026?
14 to 15 October 2026 at the Hampton Inn by Hilton, Boston Seaport District, Boston, MA.
What is the FDA real-world evidence framework?
A formal FDA program, established through the 21st Century Cures Act, that sets out how real-world evidence can support regulatory decisions, including guidance on data standards, study design and reliability.
What are common real-world evidence study designs?
Observational cohort studies, external control arms, target trial emulation, pragmatic trials, and comparative-effectiveness analyses using methods such as propensity-score matching.
Is real-world evidence the same as a clinical trial?
No. Randomized trials are controlled experiments, while real-world evidence is generated from data collected during routine care. They are complementary, and RWE can support or extend trial findings.
What are the limitations of real-world evidence?
Potential confounding, data-quality gaps, missing information and selection bias. Strong study design, transparency and validation are used to mitigate them.
How is the quality of real-world evidence assessed?
By the relevance and reliability of the underlying data, the rigor and transparency of the study design, and the reproducibility of the analysis, in line with FDA and HTA expectations.
