Development of a protocol complexity tool: a framework designed to stimulate discussion and simplify study design
We have developed a Protocol Complexity Tool to objectively measure the complexity of a study protocol consistently and transparently. The PCT is capable of driving simplification, enhancing collaboration, and creating additional confidence in trial designs. In the future, we envision the tool will support earlier discussions to develop protocols that are simpler to execute and more cost-effective.
Authors
- Ioannis Psallidas (ORCID: https://orcid.org/0000-0001-7284-0111)
- Gabriela Luporini Saraiva (ORCID: https://orcid.org/0000-0002-2131-8013)
- Bruce Potter
- Bartholomeus J.A. Willigers
- Agata E Wiesiolek
- Alina Pszczółkowska
- Cecilia Kristensson
- Veronica Presz
Institutions
- AstraZeneca (United Kingdom) (GB)
- AstraZeneca (Switzerland) (CH)
- AstraZeneca (Poland) (PL)
- AstraZeneca (Finland) (FI)
- AstraZeneca (Italy) (IT)
- AstraZeneca (Spain) (ES)
- AstraZeneca (Canada) (CA)
Publication Details
- Journal
- BMC Medical Research Methodology
- Published
- 2025-08-29
- DOI
- https://doi.org/10.1186/s12874-025-02652-9
- Primary Topic
- Statistical Methods in Clinical Trials
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- AstraZeneca