Brief · Use case · Clinical Operations
Trial Design Comparison.
LiveComparisonCompare site-based, hybrid and decentralized Phase 3 designs on enrollment reach, patient burden, data quality, acceptance and cost.
Trial Design Comparison is a ready-made use case for Clinical Operations. It ships under the Comparison template.
For clinical operations leads weighing a design. You get the designs and criteria stated first, one sourced table, where the designs differ and where the evidence is not comparable. Cells 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
How do site-based, hybrid and fully decentralized designs for a Phase 3 trial in moderate-to-severe atopic dermatitis compare on enrollment reach, patient burden, data quality, regulatory acceptance and cost?
What is compared
A decentralized element is a trial activity carried out away from a traditional site. The comparison uses the regulators’ own definitions and documents.
| Design | What it means | Where its cells come from |
|---|---|---|
| Site-based | All trial activities at traditional sites. | The baseline design in the comparison. |
| Hybrid | Some activities at sites and some elsewhere, for example telehealth or local providers.1,2 | FDA’s final guidance on decentralized elements and the EMA recommendation paper. |
| Fully decentralized | All trial activities away from traditional sites. FDA’s guidance describes a decentralized trial as one where activities take place at locations other than traditional clinical trial sites.1,2 | FDA’s final guidance (September 2024) and the EMA recommendation paper, whose national annex changes. |
What the comparison does
What regulators say. FDA finalized its guidance on decentralized elements in September 2024, replacing the May 2023 draft. The European medicines regulatory network published a recommendation paper in December 2022, with an annex on national provisions that is updated over time. The comparison reads both and says where they differ in standing.1,2
Acceptance is not the same in every country. The EMA paper is a recommendation paper from the regulatory network, and national provisions vary. The comparison records which member states matter to the trial and what their annex says, or marks the cell as a gap.2
Burden, reach and quality, with their sources. Each of these is a claim that needs evidence. The comparison cites published studies or marks the cell as a gap, and it does not carry numbers from other diseases.
Recommended length
Standard
Three designs on five criteria fit one table. Standard adds where the difference matters in about 1,200 words.
You can pick another length on the form. The other two stay available.
Assumptions the comparison checks
The comparison states the assumptions that make the cells comparable and says where they fail. Examples for this subject:
- The endpoints in moderate-to-severe atopic dermatitis can be assessed remotely with the quality the design needs.
- The countries chosen accept the decentralized elements the design uses.
- Cost figures are from comparable trials and not from a vendor’s own estimate.
Standards, guidance and sources
Regulators
- FDA, Conducting Clinical Trials With Decentralized Elements, final guidance of September 2024 (docket FDA-2022-D-2870), replacing the May 2023 draft.1
- European medicines regulatory network, Recommendation paper on the use of decentralised elements in clinical trials, first published December 2022, with a living annex on national provisions.2
The decision practice behind the memo itself is on the template page.
What gets flagged
Any cost or burden figure that is not from a comparable trial, any country whose provisions the comparison could not confirm, and any assessment that the endpoint can be captured remotely that has no source.
What arrives
- What is compared, and on what criteria
- The comparison
- Where the difference matters
- Where they do not differ
- Caveats on comparability
What it will not do
It does not recommend an item. A comparison shows how the items differ and where they do not; if you need a recommendation, run a Decision Memo on the same items.
It does not design the trial or choose the countries, and it does not replace advice from the regulators.
It does not recommend an item. A comparison shows differences; a Decision Memo recommends.
It does not handle more than five items. Beyond five, the table stops being readable and a Landscape or a Scan is the better template.
It does not invent a cell. A cell without a source is a gap, and the caveats say how many there are.
References
- [1] U.S. Food and Drug Administration. Conducting Clinical Trials With Decentralized Elements. Final guidance, September 2024. Docket FDA-2022-D-2870. Status and definition as given in FDA’s announcement and search excerpts; the guidance text was not read in full.
- [2] European Medicines Agency and the European medicines regulatory network (ACT EU). Recommendation paper on the use of decentralised elements in clinical trials. First published December 2022. Known from EMA’s news page and search excerpts. Check whether a newer version exists; the paper says it is expected to evolve.
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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