About this sample. This page shows the method and structure of the report. It contains no client data; every engagement is prepared for the specific study and indication.
1Overview
A structured review of the inclusion and exclusion criteria of a planned study. Each criterion is translated into measurable population terms and applied in sequence to an epidemiological base population, so the effect of every criterion on the eligible pool is visible and traceable.
2Questions this report answers
- ?How many patients are likely to meet the core eligibility criteria?
- ?Which individual criteria remove the largest share of the population?
- ?Are any criteria inconsistent with how the disease is diagnosed and recorded in practice?
- ?How do the criteria compare with recent registered trials in the same indication?
3Protocol
The report follows the same documented sequence for every study. Each step produces an output that is kept in the final report.
- 1
Protocol intake
The synopsis or draft protocol is reviewed and every inclusion and exclusion criterion, endpoint and key visit requirement is listed in a criteria inventory.
Output: Criteria inventory
- 2
Criteria mapping
Each criterion is expressed in measurable terms such as age range, diagnosis, disease stage, laboratory thresholds or prior therapy, with the data source that can measure it.
Output: Mapped criteria table
- 3
Population sizing
Starting from the epidemiological base population, criteria are applied one at a time. The source, date and evidence grade of every step are recorded.
Output: Eligibility funnel
- 4
Benchmarking
The criteria are compared with registered trials in the same indication and phase to identify restrictions that are unusual or stricter than common practice.
Output: Benchmark table
- 5
Risk review
Criteria with the largest effect, ambiguous wording or measurement difficulty are assessed, together with endpoint and analysis considerations.
Output: Risk register
- 6
Report and walkthrough
Findings are summarised with clear recommendations and reviewed with your team in a working session.
Output: Report and session
4Report contents
| Section | Title | What it contains |
|---|---|---|
| 1 | Executive summaryKey findings and the criteria with the greatest effect on the eligible pool. | Key findings and the criteria with the greatest effect on the eligible pool. |
| 2 | Criteria inventoryEvery criterion, how it is measured and the data used. | Every criterion, how it is measured and the data used. |
| 3 | Eligibility funnelPopulation remaining after each criterion, with evidence grades. | Population remaining after each criterion, with evidence grades. |
| 4 | Comparable trialsHow the criteria compare with registered studies in the indication. | How the criteria compare with registered studies in the indication. |
| 5 | Risk registerRecruitment and analysis risks, each with a recommendation. | Recruitment and analysis risks, each with a recommendation. |
| 6 | Assumptions appendixAll sources, dates and assumptions behind the figures. | All sources, dates and assumptions behind the figures. |
5Evidence standards
Every figure in the report carries its source, its date and one of four evidence grades, so you can see what is confirmed and what is assumed.
Confirmed
Reported directly by an authoritative source.
Documented
Published or documented, with a clear method.
Estimated
Derived by Clinovia from graded inputs.
Assumed
An explicit assumption, open to review.
6Inputs and deliverables
What we need from you
- Protocol synopsis or draft protocol
- Target countries or regions
- Planned or possible amendments, if any
What you receive
- Written report (PDF)
- Funnel and benchmark tables (Excel)
- Walkthrough session with your team
Discuss this report for your study
Tell us about the indication and the decision in front of you. A pilot on a single study is a good place to start.
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