Choodari-Oskooei, Babak;
(2024)
Designing a platform/adaptive randomised controlled trial for peripheral arterial disease (PAD) – The PAEDIS international platform trial development project.
NIHR Open Research
, 4
, Article 24. 10.3310/nihropenres.13556.1.
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Abstract
BACKGROUND: Peripheral artery disease (PAD) is a common health problem. There are several technologies, medications, and interventions that aim to improve or treat PAD in people with symptomatic disease. Most of these technologies, however, have been untested in high-quality randomised studies assessing effectiveness and their interactions remain unknown. We developed a proposed design for an international randomised controlled trial assessing multiple PAD treatments. METHODS: Over the course of 11 months (2023) several workshops and reviews of the literature took place. More specific, the proposed platform trial was designed with 44 people with PAD and 112 experts from across the world, in five work packages. The most relevant PAD treatment with unproven effectiveness were identified and key trial components as well as success criteria were defined. With input from five clinical trials units, the final format of a potential platform PAD trial in primary and secondary care was then proposed for funding. RESULTS: The proposed platform PAD randomised trial involved two major multi-arm multi-stage randomised studies, assessing PAD treatments in the community setting (1st package) and then secondary care (2nd package). The 1st package involved people with claudication and the 2nd package involves people with chronic limb threatening ischaemia (CLTI). CONCLUSIONS: A platform PAD trial involves many challenges in terms of both design and delivery. The proposed design involving both people with claudication and CLTI will hopefully act as a blueprint for future work in this area.
| Type: | Article |
|---|---|
| Title: | Designing a platform/adaptive randomised controlled trial for peripheral arterial disease (PAD) – The PAEDIS international platform trial development project |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.3310/nihropenres.13556.1 |
| Publisher version: | https://doi.org/10.3310/nihropenres.13556.1 |
| Language: | English |
| Additional information: | © 2024 Saratzis A and PAEDIS development award consortium. This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/). |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology > MRC Clinical Trials Unit at UCL |
| URI: | https://discovery.ucl.ac.uk/id/eprint/10191487 |
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