SPIRIT/CONSORT-Surrogate
Grant agreement ID: MR/V038400/1
Principal investigator: Oriana Ciani
Team UB/Cergas: Oriana Ciani
Partners: University of Glasgow, University of Bristol, University of Edinburgh
Sponsor: UK Medical Research Council
Duration: 18 months
Abstract:
This project led to the development of CONSORT (Consolidated Standards of Reporting Trials) and SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) extensions for randomised trials with a primary surrogate endpoint. These extensions are important. Incomplete, unclear, or inaccurate reporting of trial design, conduct and analysis can hinder interpretability, lead to erroneous conclusions about the long-term safety and efficacy of interventions and impact on decisions relying on those poorly reported research findings.
Material produced and publications:
Manyara AM, Davies P, Stewart D, … Ciani O. "Reporting of surrogate endpoints in randomised controlled trial reports (CONSORT-Surrogate): extension checklist with explanation and elaboration." BMJ. 2024 Jul 9;386:e078524. doi: 10.1136/bmj-2023-078524.
Manyara AM, Davies P, Stewart D, … Ciani O. "Reporting of surrogate endpoints in randomised controlled trial protocols (SPIRIT-Surrogate): extension checklist with explanation and elaboration." BMJ. 2024 Jul 9;386:e078525. doi: 10.1136/bmj-2023-078525.
Ciani O, Manyara AM, Davies P, … Taylor RS. "A framework for the definition and interpretation of the use of surrogate endpoints in interventional trials." EClinicalMedicine. 2023 Oct 17;65:102283. doi: 10.1016/j.eclinm.2023.102283.
Manyara AM, Davies P, Stewart D, …Ciani O. "Definitions, acceptability, limitations, and guidance in the use and reporting of surrogate end points in trials: a scoping review." J Clin Epidemiol. 2023 Aug;160:83-99. doi: 10.1016/j.jclinepi.2023.06.013.
Dissemination:
New guidance helps researchers set up and report on trials using surrogate outcomes, 11 July 2024
SPIRIT/CONSORT-SURROGATE - Reporting Guidelines for Surrogate Endpoints
Presentations:
HTAi Annual Meeting 2024, Seville, Spain 18 June 2024
Panel title: Surrogate Endpoints in Health Technology Assessment (HTA): From Trials to Economic Evaluations
Society for Clinical Trials, 14 March 2024
Online Webinar: CONSORT (Consolidated Standards of Reporting Trials) and SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) extensions for randomized trials reporting surrogate endpoints
PSI (Statisticians in the Pharmaceutical Industry) 29 May 2024
Online Webinar: Surrogacy
Editorials:
Ciani O, Manyara AM, Taylor RS. Surrogate endpoints in trials-a call for better reporting. BMJ. 2022 Jul 29;378:o1912. doi: 10.1136/bmj.o1912.
Ciani O, Manyara AM, Chan AW, Taylor RS; SPIRIT-SURROGATE/CONSORT-SURROGATE project group. Surrogate endpoints in trials: a call for better reporting. Trials. 2022 Dec 12;23(1):991. doi: 10.1186/s13063-022-06904-7.
Ciani O, Manyara A, Taylor RS. Need for better reporting of trials with surrogate endpoints: SPIRIT|CONSORT-SURROGATE extensions. J Epidemiol Community Health. 2022 Jun 24;76(9):769–70. doi: 10.1136/jech-2022-219294.
Manyara AM, Ciani O, Taylor RS. A call for better reporting of trials using surrogate primary endpoints. Alzheimers Dement (N Y). 2022 Jul 26;8(1):e12340. doi: 10.1002/trc2.12340.
Ciani O, Manyara AM, Taylor RS. Surrogate end points in cardio-thoracic trials: a call for better reporting and improved interpretation of trial findings. Eur J Cardiothorac Surg. 2022 Sep 2;62(4):ezac449. doi: 10.1093/ejcts/ezac449.
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