Brief · Use case · Medical Affairs
Real-World Evidence Agreement Review.
LiveEvidence ReviewReview the evidence on how closely real-world effect estimates agree with randomized trials, with certainty rated and the gaps named.
Real-World Evidence Agreement Review is a ready-made use case for Medical Affairs. It ships under the Evidence Review template.
For evidence generation leads deciding how far to lean on real-world data. You get the PICO, the main studies with effect and risk of bias, certainty per outcome and what the evidence does not settle. Studies are cited or marked as gaps.
Add it to your library to reuse from New → From template. Edit the saved copy in your library on the service form.
The decision
What does the published evidence show on how closely treatment effects estimated from real-world data agree with the effects from randomized trials of the same question?
What is reviewed
The studies here are not trials of a treatment. They are comparisons of study methods, so risk of bias is judged on the emulation and on the choice of trials, not on a clinical outcome.
| Evidence | What it holds | What the review does with it |
|---|---|---|
| RCT-DUPLICATE | Wang, Schneeweiss and colleagues emulated 32 randomized trials with US claims data (Optum Clinformatics, MarketScan and Medicare) in a JAMA paper of 2023. Agreement varied with the metric used and was strongest where the emulation matched the trial design. Divergence has several possible causes that the authors say are hard to separate.1 | JAMA 2023;329(16):1376–1385. Known from secondary sources. |
| Regulator expectations | EMA’s reflection paper on real-world data in non-interventional studies places the burden on the applicant to justify that the data are appropriate for a regulatory decision.2 | Used to frame what agreement is needed for. |
What the review does
Agreement depends on the design. The review reports that closely emulated trials agreed much better with their database studies than trials that were hard to emulate. A figure of about 0.94 for the correlation of closely emulated pairs comes from a webinar slide, and the review labels it as such.1
Selection of trials limits the reach. The emulated trials were those that could be emulated with claims data. The review notes that the result says little about questions that need clinical detail the claims do not hold.1
A reviewer’s criticism. A commentary from a research organization criticized the study for not performing quantitative bias analysis for known sources of bias. The review reports this next to the finding.1
Recommended length
Standard
The question is narrow and the studies are few enough to tabulate. Standard carries the PICO, the studies, the effect, the certainty and the open question in about 1,300 words.
You can pick another length on the form. The other two stay available.
Assumptions the review checks
The review states the assumptions its question and its rating rest on, and says what each gap limits. Examples for this question:
- The emulated trials are like the question the reader will ask.
- Agreement on average says something about agreement on a new question.
- US claims data resemble the data the reader will use.
Standards, guidance and sources
Evidence and expectations
The decision practice behind the memo itself is on the template page.
What gets flagged
Any figure taken from a slide deck or commentary and not the paper, any agreement metric that is not named, and any claim that goes beyond claims-based emulations.
What arrives
- The question and the bottom line
- How the evidence was found
- The evidence
- What it shows
- How strong it is
- Where studies disagree
- Where the evidence is thin
- What the evidence does not answer
What it will not do
It is a rapid review, not a systematic one. It reports the effects the studies reported, does not pool them into a new estimate, and labels every certainty rating as analyst judgment.
It does not say that real-world evidence is or is not acceptable for a particular submission.
It is not a systematic review. It uses a bounded search, says so, and recommends a full literature review when completeness matters.
It does not pool studies into a new estimate. It reports the effects the studies reported.
It does not compute a missing interval or plot a missing effect as zero. Both are marked as gaps.
References
- [1] Wang, S. V., Schneeweiss, S. and the RCT-DUPLICATE Initiative. Emulation of Randomized Clinical Trials With Nonrandomized Database Analyses: Results of 32 Clinical Trials. JAMA, 2023;329(16):1376–1385. Known from search results that cite the paper, FDA webinar slides and a Cytel commentary; the paper was not read in full.
- [2] European Medicines Agency. Reflection paper on use of real-world data in non-interventional studies to generate real-world evidence. Final, EMA/99865/2025. Status as given in EMA’s page listing; the paper was not read in full.
Links checked 9 October 2026
These are the sources the template drew on. None of their authors or issuers has reviewed it.
About the Brief service
A Brief is a written answer from one specialist, at the depth you asked for. It arrives with its sources, and it closes by saying plainly what would change the conclusion. Nothing is hidden behind a summary, and anything the expert could not source is marked as a gap rather than filled in.
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