Surrogate Endpoints in Clinical Trials

Surrogate Endpoints in Clinical Trials

MRC Better Methods for Health funded project (grant number MR/V038400/1) with the aims to develop extensions to core CONSORT and SPIRIT checklists for randomised trials to enable better reporting of trial protocols and reports that use surrogate endpoints. 

 

Glasgow research team

Professor Rod Taylor, Professor of Population Health Research & Co-Director of Centre for Excellence in Trials Collaboration

Dr Anthony Manyara, Honorary Research Fellow

 

 Publications

  • Ciani O, Manyara AM, Davies P, Stewart D, Weir CJ, Young AE, Blazeby J, Butcher NJ, Bujkiewicz S, Chan AW, Dawoud D, Offringa M, Ouwens M, Hróbjartssson A, Amstutz A, Bertolaccini L, Bruno VD, Devane D, Faria CDCM, Gilbert PB, Harris R, Lassere M, Marinelli L, Markham S, Powers JH, Rezaei Y, Richert L, Schwendicke F, Tereshchenko LG, Thoma A, Turan A, Worrall A, Christensen R, Collins GS, Ross JS, Taylor RS. A framework for the definition and interpretation of the use of surrogate endpoints in interventional trials. Lancet EClinicalMedicine. 2023;65:102283
  • Christensen R, Ciani O, Manyara AM, Taylor RS. Surrogate endpoints: a key concept in clinical epidemiology. J Clin Epidemiol. 2023:111242.
  • Manyara AM, Davies P, Stewart D, Weir CJ, Young A, Butcher NJ, Bujkiewicz S, Chan AW, Collins GS, Dawoud D, Offringa M, Ouwens M, Ross JS, Taylor RS, Ciani O. Protocol for the development of SPIRIT and CONSORT extensions for randomised controlled trials with surrogate primary endpoints: SPIRIT-SURROGATE and CONSORT-SURROGATE. BMJ Open. 2022;12:e064304.
  • 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;23:991.
  • 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;62:ezac449.
  • Manyara AM, Ciani O, Taylor RS. A call for better reporting of trials using surrogate primary endpoints. Alzheimers Dement. 2022 Jul 26;8(1):e12340.
  • Ciani O, Manyara AM, Taylor RS. Surrogate endpoints in trials - a call for better reporting BMJ 2022; 378 :o1912 doi:10.1136/bmj.o1912
  • Ciani O, Manyara A, Taylor RS. Need for better reporting of trials with surrogate endpoints: SPIRIT|CONSORT-SURROGATE extensions. J Epidemiol Community Health. 2022:jech-2022-219294 (on line).

 

 

Complex Intervention Reporting and Design

Complex intervention reporting and design

Updating the MRC guidance of complex interventions.

 

Glasgow research team

Professor Laurence Moore, School of Health & Wellbeing

Professor Sharon Simpson, School of Health & Wellbeing

Professor Peter Craig, School of Health & Wellbeing

Dr Kathryn Skivington Honorary Research Fellow, School of Health & Wellbeing

 

Publications

  • Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, et al. Framework for the development and evaluation of complex interventions: gap analysis, workshop and consultation-informed update. Health Technol Assess 2021;25(57)

 

  • Skivington K, Matthews L, Simpson S A, Craig P, Baird J, Blazeby J M et al. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ 2021; 374 (doi:10.1136/bmj.n2061)

 

Public Health Study Reporting and Design

Public Health study reporting and design

Examines current practice and expert consensus in relation to feasibility studies, which address key uncertainties in the design and conduct of evaluations of complex public health interventions. Aims to produce guidance that will assist researchers to more efficiently and effectively develop and conduct feasibility studies, while providing peer reviewers and research funders with objective criteria against which to assess the quality of bids and publications.

 

Glasgow research team

Professor Sharon Simpson, School of Health & Wellbeing

Professor Laurence Moore, School of Health & Wellbeing

Dr Anne Martin, Research Fellow, School of Health & Wellbeing

Dr Grace Dibben-Santillan, School of Health & Wellbeing

Professor Peter Craig, School of Health & Wellbeing

Professor Daniel Wight, School of Health & Wellbeing

 

Publications

 

  • Hallingberg, B., Turley, R., Segrott, J., Wight, D. , Craig, P. , Moore, L. , Murphy, S., Robling, M., Simpson, S. and Moore, G. (2018) Exploratory studies to decide whether and how to proceed with full-scale evaluations of public health interventions: a systematic review of guidance. Pilot and Feasibility Studies, 4, 104. (doi: 10.1186/s40814-018-0290-8) (PMID:29854417) (PMCID:PMC5971430)

 

 

Economic Evaluation

Economic evaluation

The Economic Evaluation alongside Clinical Trials Programme encompasses all research work associated with conducting an economic appraisal as part of a clinical trial.  Although modelling methods may still be required to provide a comprehensive appraisal, the characterising feature is the inclusion of an economic component to the trial and the availability of experimental data on both costs and effects of treatment. 

Glasgow research team

Programmes Lead: Professor Kathleen BoydHealth Economics & Health Technology Assessment

Studies Within A Trial (SWATS)

SWATS

In addition to randomised trials and clinical studies that we undertake, we are also interested in trials methodology, i.e. how we design and run clinical trials in order to make them more efficient. Some of our methodology studies are standalone and others are embedded within randomised trials, known as SWATs (Studies Within A Trial).

 Enhanced participant information sheet for the recruitment of caregivers to a multicentre randomised trial

Hypothesis: Caregivers/support persons who receive an enhanced PIS will be more likely to agree to participate and more likely be retained in the REACH-HFpEF trial (host trial) compared to caregivers/support persons receiving usual PIS. https://www.isrctn.com/ISRCTN15757498