Real-World Evidence · Study Design
Designing a Real-World Evidence Study
A real-world evidence study turns routine healthcare data into a credible answer, but only if it is designed with the same rigor as a trial.
The craft of designing these studies is a core thread at RWE Connect 2026 in Boston.
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Why design matters
The Study Is Only as Good as Its Design
A real-world evidence study draws on data generated by routine care, not a controlled trial. That makes it powerful and representative, but also vulnerable to bias if it is not designed carefully.
Good design is what separates a credible real-world study from a misleading one. It applies the RWE methods toolkit to a specific question, and it underpins everything from HEOR to regulatory submissions.
The options
Types of Real-World Evidence Study
Different questions call for different designs. These are the workhorses of real-world research.
How to do it
Designing the Study, Step by Step
A well-designed study is built in a deliberate order, with the target trial as its north star.
The decisions
Key Design Choices
A handful of choices shape the credibility of the whole study. Each deserves careful thought.
What to watch for
Common Pitfalls in RWE Studies
Most flawed real-world studies fall into a few well-known traps. Knowing them is the first line of defense.
The direction of travel
Where RWE Study Design Is Heading in 2026
Study design is being sharpened by new frameworks, richer data and better methods. These are the shifts on the agenda at RWE Connect 2026.
Who is in the room
Who Attends RWE Connect 2026
A senior, focused audience of the people who design and defend real-world studies.
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.
Explore
Explore Related Methods
Study design draws on the full real-world evidence methods toolkit.
Sponsor RWE Connect 2026
Meet the Study Designers in Boston
The teams that design and run real-world studies gather at RWE Connect 2026: 150+ attendees, around 60% at Director or VP level and above.
RWE Connect 2026
Get the RWE Study Methods Primer
A plain-English guide to the methods behind a credible real-world study. See the methods, then meet the people applying them in Boston.
- How to design around bias
- What makes a study regulatory-grade
- Where study design is heading in 2026
Free. Instant download. No obligation.
Real-World Evidence Studies: Common Questions
What is a real-world evidence study?
A real-world evidence study uses data collected outside clinical trials, such as EHRs, claims and registries, to answer a question about how a treatment is used or how well it works in everyday practice.
How do you design a real-world evidence study?
Frame a clear question, emulate a target trial, choose fit-for-purpose data, define the population and outcomes, plan how to control bias, and pre-specify the analysis before running it.
What are the types of real-world evidence study?
Retrospective and prospective cohort studies, case-control studies, cross-sectional studies, registry-based studies and pragmatic clinical trials.
What is target trial emulation?
A framework that designs a real-world study to mimic the randomized trial you would ideally run, which helps avoid common biases and makes the results more credible.
How is an RWE study different from a clinical trial?
A clinical trial assigns treatment under controlled conditions. An RWE study observes treatment as it happens in routine care, so it needs careful design and methods to draw reliable conclusions.
What data is used in a real-world evidence study?
Electronic health records, administrative claims, disease registries, patient-reported and wearable data, and linked or tokenized datasets.
How do you control bias in an RWE study?
Through careful eligibility and time-zero definitions, propensity scores and adjustment for confounders, clear exposure and outcome definitions, and sensitivity analyses.
What is immortal time bias?
A design flaw where a period during which the outcome could not occur is misclassified, making a treatment look more effective than it is. Careful time-zero definition avoids it.
What makes an RWE study regulatory-grade?
Fit-for-purpose data, a pre-specified protocol, rigorous bias control, clear data provenance and transparent reporting, aligned with regulatory guidance.
How do you avoid confounding?
By measuring and adjusting for the factors that influence both treatment and outcome, using methods such as propensity scores, weighting and sensitivity analyses for unmeasured confounders.
What is RWE Connect 2026?
RWE Connect 2026 is a two-day real-world evidence summit in Boston bringing together the RWE, HEOR and methods 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.
