Brief · Use case · Market Access
Real-World Evidence Study Plan.
LivePlanPlan a real-world evidence study for payer negotiations, from protocol to report, with the data access and approval clocks.
Real-World Evidence Study Plan is a ready-made use case for Market Access. It ships under the Plan template.
For HEOR leads. You get the objective and critical path, the milestones with exit criteria and owners, the data access and approval dependencies, what could derail the plan and the first move. Durations are cited, marked as estimates 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 is the plan for a real-world evidence study to support payer negotiations for a specialty therapy, from protocol design to a payer-ready report?
The steps of the plan
A payer-ready study is specified before data are touched. The plan sequences the steps and marks the ones where the study can be judged by someone else.
| Step | What it involves | The clock or source |
|---|---|---|
| Specify the protocol | Write the protocol on a harmonized template so that reviewers can judge the risk of bias and repeat the analysis.1 | The HARPER protocol template from ISPE and ISPOR. |
| Check the data are fit | Assess feasibility: whether the data hold the outcomes, exposures and confounders the question needs, and say how data quality will be shown.2,3 | EMA’s reflection paper on real-world data in non-interventional studies, and the NICE framework. |
| Analyze and test | Run the pre-specified analysis, with sensitivity and bias analyses so the result can be tested against the main risks.3 | The NICE real-world evidence framework. |
| Report for the payer | Report in the form the payer will use, and say what the study can and cannot show. | The payer’s own requirements, named in the plan. |
What the plan does
Specify before you analyze. The HARPER template was developed by an ISPE and ISPOR task force so that the parameters defining the causal question, such as the target estimand, are documented and reviewers can assess the potential for bias. The plan puts the protocol step before any analysis.1
Fit for purpose is the responsibility of the sponsor. EMA’s reflection paper, finalized in 2025 after consultation in 2024, covers methodological aspects of non-interventional studies using real-world data and notes that it is for the applicant to justify that the use of such data is appropriate. The plan makes that justification a step with an owner.2
A framework for what payers will test. NICE’s framework asks for good provenance, relevance and quality of data, transparent generation, and methods that minimize bias and characterize uncertainty, and says that randomized trials remain the reference standard for causal effects. The plan builds those checks into the sequence.3
How it could fail. The pre-mortem probes the failures this plan invites: a data source that lacks a key confounder, a protocol the payer does not accept, an analysis that changes after the data are seen, or a delay in data access.
Recommended length
Comprehensive
Several parties are involved and decisions have to be taken along the way. Comprehensive adds the gates, the responsibility table and the risk map.
You can pick another length on the form. The other two stay available.
Assumptions the plan checks
The plan states the assumptions its dates rest on and says which one would move the finish if it failed. Examples for this plan:
- The data source holds the outcome and the confounders the protocol names.
- The payer accepts the study design before data are analyzed.
- Data access can be agreed within the time the plan allows.
Standards, guidance and sources
Protocol and conduct
The decision practice behind the memo itself is on the template page.
What gets flagged
Any step that depends on data access not yet agreed, any confounder the data may not hold, and any payer requirement the plan could not confirm.
What arrives
- The objective
- The sequence
- Gates and decisions
- Who is needed
- Dependencies and external clocks
- What could derail it
- The first move
What it will not do
It does not promise dates. Each duration is sourced or marked as an estimate, and an unpublished deadline is a gap.
It does not run the study, and it does not guarantee a payer will accept the result.
It does not guarantee the dates. The durations are sourced or marked as estimates, and the plan says which.
It does not invent an agency’s deadlines. A deadline that is not published is a gap.
It does not run the plan. It gives an owner the first move and the criteria for the next gate.
References
- [1] Wang, S. V. et al. HARmonized Protocol Template to Enhance Reproducibility of hypothesis evaluating real-world evidence studies on treatment effects: a good practices report of a joint ISPE/ISPOR task force. Value in Health, 2022;25(10):1663–1672. Summarized from ISPOR’s page and search excerpts; the full text is behind a paywall.
- [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; draft EMA/CHMP/150527/2024 consulted 3 May to 31 August 2024. Status and dates as given in EMA’s page listing and search excerpts; the paper was not read in full.
- [3] National Institute for Health and Care Excellence. NICE real-world evidence framework (ECD9). Published 23 June 2022. Known from NICE’s page listing and search excerpts; the framework 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.
To edit a saved template, open New → Brief → From template, or the library rail on the service form.