PSI Webinar: Surrogacy

Joint PSI/EFSPI Visualisation SIG 'Wonderful Wednesday' Webinars

Our monthly webinar explores examples of innovative data visualisations relevant to our day to day work. Each month a new dataset is provided from a clinical trial or other relevant example, and participants are invited to submit a graphic that communicates interesting and relevant characteristics of the data.

AIMS SIG - Open-Source Lunch Bites

Topic: R Package Basics. Our monthly webinar series allows attendees to gain practical knowledge and skills in open-source coding and tools, with a focus on applications in the pharmaceutical industry. This month’s session, “R Package Basics,” will introduce the fundamentals of working with R packages—covering how to install, load, and manage them effectively to support data analysis and reproducible research. The session will provide a solid starting point, clarify common misconceptions, and offer valuable resources for continued learning.

PSI Mentoring 2026

Date: Ongoing 6 month cycle beginning late April/early May 2026 Are you a member of PSI looking to further your career or help develop others - why not sign up to the PSI Mentoring scheme? You can expand your network, improve your leadership skills and learn from more senior colleagues in the industry.

PSI Book Club Lunch and Learn: Communicating with Clarity and Confidence

If you have read Ros Atkins’ book The Art of Explanation or want to listen to the BBC’s ‘Communicator in Chief’, you are invited to join the PSI Book Club Lunch and Learn, to discuss the content and application with the author, Ros Atkins. Having written the book within the context of the news industry, Ros is keen to hear how we have applied the ideas as statisticians within drug development and clinical trials. There will be dedicated time during the webinar to ASK THE AUTHOR any questions – don’t miss out on this exclusive PSI Book Club event! Haven’t read the book yet? Pick up a copy today and join us. Explanation - identifying and communicating what we want to say - is described as an art, in the title of his book. However, the creativity comes from Ros’ discernment in identifying and describing a clear step-by-step process to follow and practice. Readers can learn Ros’ rules, developed and polished throughout his career as a journalist, to help communicate complex written or spoken information clearly.

PSI Training Course: Effective Leadership – the keys to growing your leadership capabilities

This course will consist of three online half-day workshops. The first will be aimed at building trust, the backbone of leadership and a key to becoming effective. This is key to building a solid foundation. The second will be on improving communication as a technical leader. This workshop will focus on communication strategies for different stakeholders and will involve tips on effective communication and how to develop the skills of active listening, coaching and what improv can teach us about good communication. The final workshop will bring these two components together to help leaders become more influential. This will also focus on how to use Steven Covey’s 7-Habits, in particular Habits 4, 5 and 6, which are called the habits of communication. The workshops will be interactive, allowing you to practice the concepts discussed. There will be plenty of time for questions and discussion. There will also be reflective time where you can think about what you are learning and how you might experiment with it.

Speaker	Biography	Abstract
Oriana Ciani	Oriana Ciani is Associate Professor of Practice, Public Management and Policy Area, Health Economics and HTA at SDA Bocconi School of Management. Her research interests focus on methodological aspects of Health Technology Assessment (HTA), evidence synthesis and surrogate endpoints validation. She has led the development of CONSORT and SPIRIT extensions for RCTs with surrogate endpoints (MRC CONSORT-SPIRIT). Oriana is currently PI for the three-year HORIZON Europe HI-PRIX project (no. 101095593), on innovative pricing and payment schemes for health technologies. In 2020 Oriana is Fulbright Research Scholar at the Yale School of Medicine and the Yale School of Public Health. Oriana is Associate Editor of Value in Health. For her research activity she has received the Egon Jonsson Award (2016), the Bocconi Research Award (2023), the Exeter Impact Award (2013), Best Student Podium Presentation Award at the ISPOR Conference in Dublin (2013), the AIES Young Researcher Award (2010).	A significant proportion of clinical trials across different therapeutic areas use surrogate endpoints as primary outcomes. After introducing a published definitional framework for surrogate endpoints in trials, the presentation will highlight the advantages and challenges of using them for clinical and regulatory decision-making. Finally, an overview of available validation approaches will be provided.
Rod Taylor	Rod Taylor is Professor of Population Health Research and co-Director of Centre for Excellence in Trials Collaboration, University of Glasgow; Adjunct Professor, Faculty of Health Sciences – National Institute of Public Health and Department of Psychology, University of South Denmark. He has published over 500 peer review articles the field of health services research and has an H-index of 125 and i10-index 416. Rod’s main research interests and expertise include cardiovascular secondary prevention/rehabilitation trials: REACH-HFpEF Trial, PERFORM trial, ACROSS trial and trial methodology. He is currently leading the development of CONSORT and SPIRIT extensions for RCTs with surrogate endpoints (MRC CONSORT-SPIRIT) and he is member of the Strategy Committee of the UK Medical Research Council (MRC) and National Institute for Health Research (NIHR) Trial Methodology Research Partnership (TMRP). He is the Director for the Cardiac Rehabilitation Cochrane Review Centre (CochraneCardiacRehabCentre). His postgraduate qualifications include PhD Clinical Physiology (Glasgow), MSc in Medical Statistics (London) and Postgrad. Dip. Health Economics (Aberdeen). His postgraduate qualifications include PhD Clinical Physiology (Glasgow), MSc in Medical Statistics (London) and Postgrad. Dip. Health Economics (Aberdeen).	This presentation will describe the process by which we developed extensions to the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) and CONSORT (Consolidated Standards of Reporting Trials) reporting guidelines to improve the design and completeness of reporting of RCTs and their protocols using a surrogate endpoint as a primary outcome. In brief, the project used the 4-stage process recommended for development of methods guidance by EQUATOR: stage 1 (literature reviews) to identify candidate reporting items to be rated in a Delphi study; stage 2 (e-Delphi study) to rate the importance of items identified in stage 1 & receive suggestions for additional items; stage 3 (consensus meeting) to agree on final set of items for inclusion in the extensions; stage 4 (knowledge translation) to engage stakeholders and disseminate the project outputs through various strategies including peer-reviewed publications. Patient and public involvement was embedded into all project phases.
Anthony Manyara	Anthony Manyara is a Research Associate and Epidemiologist at the Global Health and Ageing Research Unit, Bristol Medical School, University of Bristol and Honorary Research Fellow at the School of Health and Wellbeing, University of Glasgow. His research interests include surrogate endpoints use and reporting, evidence synthesis, noncommunicable disease prevention and control. He is a member of the MRC-NIHR Trials Methodology Research Partnership Surrogate Endpoints subgroup. Anthony coordinated the development of the SPIRIT and CONSORT extensions for reporting trials using surrogate endpoints as a postdoctoral researcher and is keen to see the extensions implemented to improve trial reporting, reduce research waste, and better patient care and population health.	After introducing the development of the SPIRIT\|CONSORT-Surrogate extension, the extension items to be reported for both protocols and trial reports will be presented. A rationale for reporting each item and examples of good reporting will be provided.
Ray Harris	Ray Harris is retired from a career in various statistical roles, mostly in the pharmaceutical industry. He worked across all stages of drug development. He is an honorary member of PSI and a Chartered Statistician. He continues to use his experience in a variety of volunteer roles. He is a lay member of an ethics committee and an expert member of the Oxford Primary Care Hosted Research Datasets Independent Scientific Committee. He is a PPI member in a number of groups. He has found that years of asking questions as a non-clinical member of a research team transitions very well to asking questions from a patient and public interest point of view.	From the beginning of the project patient and public involvement (PPI) was recognised as a key part of the process, engaging representatives of a key stakeholder community. The presentation will outline the PPI involvement; representing the views, interests and concerns of the public; and the benefits of PPI engagement.
Mario Ouwens	Mario Ouwens is group director in medical and statistical evidence statistics at AstraZeneca. He is co-leading the ISPOR surrogacy taskforce and has participated in the development of the CONSORT and SPIRIT extensions.	A simulation study will be presented showing that it is quite unlikely to satisfy the IQWiG rules for more chronic diseases. The impact of the following factors will be evaluated for a time-to-event late outcome and continuous early outcome: a) Trial duration b) Sample size c) Number of trials d) Variation in treatment effect on early outcome e) Rate of mortality f) Extend to which late outcome can be explained by relation between early and late outcome Treatment effect on late outcome

Speaker	Biography	Abstract
Oriana Ciani	Oriana Ciani is Associate Professor of Practice, Public Management and Policy Area, Health Economics and HTA at SDA Bocconi School of Management. Her research interests focus on methodological aspects of Health Technology Assessment (HTA), evidence synthesis and surrogate endpoints validation. She has led the development of CONSORT and SPIRIT extensions for RCTs with surrogate endpoints (MRC CONSORT-SPIRIT). Oriana is currently PI for the three-year HORIZON Europe HI-PRIX project (no. 101095593), on innovative pricing and payment schemes for health technologies. In 2020 Oriana is Fulbright Research Scholar at the Yale School of Medicine and the Yale School of Public Health. Oriana is Associate Editor of Value in Health. For her research activity she has received the Egon Jonsson Award (2016), the Bocconi Research Award (2023), the Exeter Impact Award (2013), Best Student Podium Presentation Award at the ISPOR Conference in Dublin (2013), the AIES Young Researcher Award (2010).	A significant proportion of clinical trials across different therapeutic areas use surrogate endpoints as primary outcomes. After introducing a published definitional framework for surrogate endpoints in trials, the presentation will highlight the advantages and challenges of using them for clinical and regulatory decision-making. Finally, an overview of available validation approaches will be provided.
Rod Taylor	Rod Taylor is Professor of Population Health Research and co-Director of Centre for Excellence in Trials Collaboration, University of Glasgow; Adjunct Professor, Faculty of Health Sciences – National Institute of Public Health and Department of Psychology, University of South Denmark. He has published over 500 peer review articles the field of health services research and has an H-index of 125 and i10-index 416. Rod’s main research interests and expertise include cardiovascular secondary prevention/rehabilitation trials: REACH-HFpEF Trial, PERFORM trial, ACROSS trial and trial methodology. He is currently leading the development of CONSORT and SPIRIT extensions for RCTs with surrogate endpoints (MRC CONSORT-SPIRIT) and he is member of the Strategy Committee of the UK Medical Research Council (MRC) and National Institute for Health Research (NIHR) Trial Methodology Research Partnership (TMRP). He is the Director for the Cardiac Rehabilitation Cochrane Review Centre (CochraneCardiacRehabCentre). His postgraduate qualifications include PhD Clinical Physiology (Glasgow), MSc in Medical Statistics (London) and Postgrad. Dip. Health Economics (Aberdeen). His postgraduate qualifications include PhD Clinical Physiology (Glasgow), MSc in Medical Statistics (London) and Postgrad. Dip. Health Economics (Aberdeen).	This presentation will describe the process by which we developed extensions to the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) and CONSORT (Consolidated Standards of Reporting Trials) reporting guidelines to improve the design and completeness of reporting of RCTs and their protocols using a surrogate endpoint as a primary outcome. In brief, the project used the 4-stage process recommended for development of methods guidance by EQUATOR: stage 1 (literature reviews) to identify candidate reporting items to be rated in a Delphi study; stage 2 (e-Delphi study) to rate the importance of items identified in stage 1 & receive suggestions for additional items; stage 3 (consensus meeting) to agree on final set of items for inclusion in the extensions; stage 4 (knowledge translation) to engage stakeholders and disseminate the project outputs through various strategies including peer-reviewed publications. Patient and public involvement was embedded into all project phases.
Anthony Manyara	Anthony Manyara is a Research Associate and Epidemiologist at the Global Health and Ageing Research Unit, Bristol Medical School, University of Bristol and Honorary Research Fellow at the School of Health and Wellbeing, University of Glasgow. His research interests include surrogate endpoints use and reporting, evidence synthesis, noncommunicable disease prevention and control. He is a member of the MRC-NIHR Trials Methodology Research Partnership Surrogate Endpoints subgroup. Anthony coordinated the development of the SPIRIT and CONSORT extensions for reporting trials using surrogate endpoints as a postdoctoral researcher and is keen to see the extensions implemented to improve trial reporting, reduce research waste, and better patient care and population health.	After introducing the development of the SPIRIT\|CONSORT-Surrogate extension, the extension items to be reported for both protocols and trial reports will be presented. A rationale for reporting each item and examples of good reporting will be provided.
Ray Harris	Ray Harris is retired from a career in various statistical roles, mostly in the pharmaceutical industry. He worked across all stages of drug development. He is an honorary member of PSI and a Chartered Statistician. He continues to use his experience in a variety of volunteer roles. He is a lay member of an ethics committee and an expert member of the Oxford Primary Care Hosted Research Datasets Independent Scientific Committee. He is a PPI member in a number of groups. He has found that years of asking questions as a non-clinical member of a research team transitions very well to asking questions from a patient and public interest point of view.	From the beginning of the project patient and public involvement (PPI) was recognised as a key part of the process, engaging representatives of a key stakeholder community. The presentation will outline the PPI involvement; representing the views, interests and concerns of the public; and the benefits of PPI engagement.
Mario Ouwens	Mario Ouwens is group director in medical and statistical evidence statistics at AstraZeneca. He is co-leading the ISPOR surrogacy taskforce and has participated in the development of the CONSORT and SPIRIT extensions.	A simulation study will be presented showing that it is quite unlikely to satisfy the IQWiG rules for more chronic diseases. The impact of the following factors will be evaluated for a time-to-event late outcome and continuous early outcome: a) Trial duration b) Sample size c) Number of trials d) Variation in treatment effect on early outcome e) Rate of mortality f) Extend to which late outcome can be explained by relation between early and late outcome Treatment effect on late outcome

Speaker	Biography	Abstract
Oriana Ciani	Oriana Ciani is Associate Professor of Practice, Public Management and Policy Area, Health Economics and HTA at SDA Bocconi School of Management. Her research interests focus on methodological aspects of Health Technology Assessment (HTA), evidence synthesis and surrogate endpoints validation. She has led the development of CONSORT and SPIRIT extensions for RCTs with surrogate endpoints (MRC CONSORT-SPIRIT). Oriana is currently PI for the three-year HORIZON Europe HI-PRIX project (no. 101095593), on innovative pricing and payment schemes for health technologies. In 2020 Oriana is Fulbright Research Scholar at the Yale School of Medicine and the Yale School of Public Health. Oriana is Associate Editor of Value in Health. For her research activity she has received the Egon Jonsson Award (2016), the Bocconi Research Award (2023), the Exeter Impact Award (2013), Best Student Podium Presentation Award at the ISPOR Conference in Dublin (2013), the AIES Young Researcher Award (2010).	A significant proportion of clinical trials across different therapeutic areas use surrogate endpoints as primary outcomes. After introducing a published definitional framework for surrogate endpoints in trials, the presentation will highlight the advantages and challenges of using them for clinical and regulatory decision-making. Finally, an overview of available validation approaches will be provided.
Rod Taylor	Rod Taylor is Professor of Population Health Research and co-Director of Centre for Excellence in Trials Collaboration, University of Glasgow; Adjunct Professor, Faculty of Health Sciences – National Institute of Public Health and Department of Psychology, University of South Denmark. He has published over 500 peer review articles the field of health services research and has an H-index of 125 and i10-index 416. Rod’s main research interests and expertise include cardiovascular secondary prevention/rehabilitation trials: REACH-HFpEF Trial, PERFORM trial, ACROSS trial and trial methodology. He is currently leading the development of CONSORT and SPIRIT extensions for RCTs with surrogate endpoints (MRC CONSORT-SPIRIT) and he is member of the Strategy Committee of the UK Medical Research Council (MRC) and National Institute for Health Research (NIHR) Trial Methodology Research Partnership (TMRP). He is the Director for the Cardiac Rehabilitation Cochrane Review Centre (CochraneCardiacRehabCentre). His postgraduate qualifications include PhD Clinical Physiology (Glasgow), MSc in Medical Statistics (London) and Postgrad. Dip. Health Economics (Aberdeen). His postgraduate qualifications include PhD Clinical Physiology (Glasgow), MSc in Medical Statistics (London) and Postgrad. Dip. Health Economics (Aberdeen).	This presentation will describe the process by which we developed extensions to the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) and CONSORT (Consolidated Standards of Reporting Trials) reporting guidelines to improve the design and completeness of reporting of RCTs and their protocols using a surrogate endpoint as a primary outcome. In brief, the project used the 4-stage process recommended for development of methods guidance by EQUATOR: stage 1 (literature reviews) to identify candidate reporting items to be rated in a Delphi study; stage 2 (e-Delphi study) to rate the importance of items identified in stage 1 & receive suggestions for additional items; stage 3 (consensus meeting) to agree on final set of items for inclusion in the extensions; stage 4 (knowledge translation) to engage stakeholders and disseminate the project outputs through various strategies including peer-reviewed publications. Patient and public involvement was embedded into all project phases.
Anthony Manyara	Anthony Manyara is a Research Associate and Epidemiologist at the Global Health and Ageing Research Unit, Bristol Medical School, University of Bristol and Honorary Research Fellow at the School of Health and Wellbeing, University of Glasgow. His research interests include surrogate endpoints use and reporting, evidence synthesis, noncommunicable disease prevention and control. He is a member of the MRC-NIHR Trials Methodology Research Partnership Surrogate Endpoints subgroup. Anthony coordinated the development of the SPIRIT and CONSORT extensions for reporting trials using surrogate endpoints as a postdoctoral researcher and is keen to see the extensions implemented to improve trial reporting, reduce research waste, and better patient care and population health.	After introducing the development of the SPIRIT\|CONSORT-Surrogate extension, the extension items to be reported for both protocols and trial reports will be presented. A rationale for reporting each item and examples of good reporting will be provided.
Ray Harris	Ray Harris is retired from a career in various statistical roles, mostly in the pharmaceutical industry. He worked across all stages of drug development. He is an honorary member of PSI and a Chartered Statistician. He continues to use his experience in a variety of volunteer roles. He is a lay member of an ethics committee and an expert member of the Oxford Primary Care Hosted Research Datasets Independent Scientific Committee. He is a PPI member in a number of groups. He has found that years of asking questions as a non-clinical member of a research team transitions very well to asking questions from a patient and public interest point of view.	From the beginning of the project patient and public involvement (PPI) was recognised as a key part of the process, engaging representatives of a key stakeholder community. The presentation will outline the PPI involvement; representing the views, interests and concerns of the public; and the benefits of PPI engagement.
Mario Ouwens	Mario Ouwens is group director in medical and statistical evidence statistics at AstraZeneca. He is co-leading the ISPOR surrogacy taskforce and has participated in the development of the CONSORT and SPIRIT extensions.	A simulation study will be presented showing that it is quite unlikely to satisfy the IQWiG rules for more chronic diseases. The impact of the following factors will be evaluated for a time-to-event late outcome and continuous early outcome: a) Trial duration b) Sample size c) Number of trials d) Variation in treatment effect on early outcome e) Rate of mortality f) Extend to which late outcome can be explained by relation between early and late outcome Treatment effect on late outcome

Speaker	Biography	Abstract
Oriana Ciani	Oriana Ciani is Associate Professor of Practice, Public Management and Policy Area, Health Economics and HTA at SDA Bocconi School of Management. Her research interests focus on methodological aspects of Health Technology Assessment (HTA), evidence synthesis and surrogate endpoints validation. She has led the development of CONSORT and SPIRIT extensions for RCTs with surrogate endpoints (MRC CONSORT-SPIRIT). Oriana is currently PI for the three-year HORIZON Europe HI-PRIX project (no. 101095593), on innovative pricing and payment schemes for health technologies. In 2020 Oriana is Fulbright Research Scholar at the Yale School of Medicine and the Yale School of Public Health. Oriana is Associate Editor of Value in Health. For her research activity she has received the Egon Jonsson Award (2016), the Bocconi Research Award (2023), the Exeter Impact Award (2013), Best Student Podium Presentation Award at the ISPOR Conference in Dublin (2013), the AIES Young Researcher Award (2010).	A significant proportion of clinical trials across different therapeutic areas use surrogate endpoints as primary outcomes. After introducing a published definitional framework for surrogate endpoints in trials, the presentation will highlight the advantages and challenges of using them for clinical and regulatory decision-making. Finally, an overview of available validation approaches will be provided.
Rod Taylor	Rod Taylor is Professor of Population Health Research and co-Director of Centre for Excellence in Trials Collaboration, University of Glasgow; Adjunct Professor, Faculty of Health Sciences – National Institute of Public Health and Department of Psychology, University of South Denmark. He has published over 500 peer review articles the field of health services research and has an H-index of 125 and i10-index 416. Rod’s main research interests and expertise include cardiovascular secondary prevention/rehabilitation trials: REACH-HFpEF Trial, PERFORM trial, ACROSS trial and trial methodology. He is currently leading the development of CONSORT and SPIRIT extensions for RCTs with surrogate endpoints (MRC CONSORT-SPIRIT) and he is member of the Strategy Committee of the UK Medical Research Council (MRC) and National Institute for Health Research (NIHR) Trial Methodology Research Partnership (TMRP). He is the Director for the Cardiac Rehabilitation Cochrane Review Centre (CochraneCardiacRehabCentre). His postgraduate qualifications include PhD Clinical Physiology (Glasgow), MSc in Medical Statistics (London) and Postgrad. Dip. Health Economics (Aberdeen). His postgraduate qualifications include PhD Clinical Physiology (Glasgow), MSc in Medical Statistics (London) and Postgrad. Dip. Health Economics (Aberdeen).	This presentation will describe the process by which we developed extensions to the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) and CONSORT (Consolidated Standards of Reporting Trials) reporting guidelines to improve the design and completeness of reporting of RCTs and their protocols using a surrogate endpoint as a primary outcome. In brief, the project used the 4-stage process recommended for development of methods guidance by EQUATOR: stage 1 (literature reviews) to identify candidate reporting items to be rated in a Delphi study; stage 2 (e-Delphi study) to rate the importance of items identified in stage 1 & receive suggestions for additional items; stage 3 (consensus meeting) to agree on final set of items for inclusion in the extensions; stage 4 (knowledge translation) to engage stakeholders and disseminate the project outputs through various strategies including peer-reviewed publications. Patient and public involvement was embedded into all project phases.
Anthony Manyara	Anthony Manyara is a Research Associate and Epidemiologist at the Global Health and Ageing Research Unit, Bristol Medical School, University of Bristol and Honorary Research Fellow at the School of Health and Wellbeing, University of Glasgow. His research interests include surrogate endpoints use and reporting, evidence synthesis, noncommunicable disease prevention and control. He is a member of the MRC-NIHR Trials Methodology Research Partnership Surrogate Endpoints subgroup. Anthony coordinated the development of the SPIRIT and CONSORT extensions for reporting trials using surrogate endpoints as a postdoctoral researcher and is keen to see the extensions implemented to improve trial reporting, reduce research waste, and better patient care and population health.	After introducing the development of the SPIRIT\|CONSORT-Surrogate extension, the extension items to be reported for both protocols and trial reports will be presented. A rationale for reporting each item and examples of good reporting will be provided.
Ray Harris	Ray Harris is retired from a career in various statistical roles, mostly in the pharmaceutical industry. He worked across all stages of drug development. He is an honorary member of PSI and a Chartered Statistician. He continues to use his experience in a variety of volunteer roles. He is a lay member of an ethics committee and an expert member of the Oxford Primary Care Hosted Research Datasets Independent Scientific Committee. He is a PPI member in a number of groups. He has found that years of asking questions as a non-clinical member of a research team transitions very well to asking questions from a patient and public interest point of view.	From the beginning of the project patient and public involvement (PPI) was recognised as a key part of the process, engaging representatives of a key stakeholder community. The presentation will outline the PPI involvement; representing the views, interests and concerns of the public; and the benefits of PPI engagement.
Mario Ouwens	Mario Ouwens is group director in medical and statistical evidence statistics at AstraZeneca. He is co-leading the ISPOR surrogacy taskforce and has participated in the development of the CONSORT and SPIRIT extensions.	A simulation study will be presented showing that it is quite unlikely to satisfy the IQWiG rules for more chronic diseases. The impact of the following factors will be evaluated for a time-to-event late outcome and continuous early outcome: a) Trial duration b) Sample size c) Number of trials d) Variation in treatment effect on early outcome e) Rate of mortality f) Extend to which late outcome can be explained by relation between early and late outcome Treatment effect on late outcome

Speaker	Biography	Abstract
Oriana Ciani	Oriana Ciani is Associate Professor of Practice, Public Management and Policy Area, Health Economics and HTA at SDA Bocconi School of Management. Her research interests focus on methodological aspects of Health Technology Assessment (HTA), evidence synthesis and surrogate endpoints validation. She has led the development of CONSORT and SPIRIT extensions for RCTs with surrogate endpoints (MRC CONSORT-SPIRIT). Oriana is currently PI for the three-year HORIZON Europe HI-PRIX project (no. 101095593), on innovative pricing and payment schemes for health technologies. In 2020 Oriana is Fulbright Research Scholar at the Yale School of Medicine and the Yale School of Public Health. Oriana is Associate Editor of Value in Health. For her research activity she has received the Egon Jonsson Award (2016), the Bocconi Research Award (2023), the Exeter Impact Award (2013), Best Student Podium Presentation Award at the ISPOR Conference in Dublin (2013), the AIES Young Researcher Award (2010).	A significant proportion of clinical trials across different therapeutic areas use surrogate endpoints as primary outcomes. After introducing a published definitional framework for surrogate endpoints in trials, the presentation will highlight the advantages and challenges of using them for clinical and regulatory decision-making. Finally, an overview of available validation approaches will be provided.
Rod Taylor	Rod Taylor is Professor of Population Health Research and co-Director of Centre for Excellence in Trials Collaboration, University of Glasgow; Adjunct Professor, Faculty of Health Sciences – National Institute of Public Health and Department of Psychology, University of South Denmark. He has published over 500 peer review articles the field of health services research and has an H-index of 125 and i10-index 416. Rod’s main research interests and expertise include cardiovascular secondary prevention/rehabilitation trials: REACH-HFpEF Trial, PERFORM trial, ACROSS trial and trial methodology. He is currently leading the development of CONSORT and SPIRIT extensions for RCTs with surrogate endpoints (MRC CONSORT-SPIRIT) and he is member of the Strategy Committee of the UK Medical Research Council (MRC) and National Institute for Health Research (NIHR) Trial Methodology Research Partnership (TMRP). He is the Director for the Cardiac Rehabilitation Cochrane Review Centre (CochraneCardiacRehabCentre). His postgraduate qualifications include PhD Clinical Physiology (Glasgow), MSc in Medical Statistics (London) and Postgrad. Dip. Health Economics (Aberdeen). His postgraduate qualifications include PhD Clinical Physiology (Glasgow), MSc in Medical Statistics (London) and Postgrad. Dip. Health Economics (Aberdeen).	This presentation will describe the process by which we developed extensions to the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) and CONSORT (Consolidated Standards of Reporting Trials) reporting guidelines to improve the design and completeness of reporting of RCTs and their protocols using a surrogate endpoint as a primary outcome. In brief, the project used the 4-stage process recommended for development of methods guidance by EQUATOR: stage 1 (literature reviews) to identify candidate reporting items to be rated in a Delphi study; stage 2 (e-Delphi study) to rate the importance of items identified in stage 1 & receive suggestions for additional items; stage 3 (consensus meeting) to agree on final set of items for inclusion in the extensions; stage 4 (knowledge translation) to engage stakeholders and disseminate the project outputs through various strategies including peer-reviewed publications. Patient and public involvement was embedded into all project phases.
Anthony Manyara	Anthony Manyara is a Research Associate and Epidemiologist at the Global Health and Ageing Research Unit, Bristol Medical School, University of Bristol and Honorary Research Fellow at the School of Health and Wellbeing, University of Glasgow. His research interests include surrogate endpoints use and reporting, evidence synthesis, noncommunicable disease prevention and control. He is a member of the MRC-NIHR Trials Methodology Research Partnership Surrogate Endpoints subgroup. Anthony coordinated the development of the SPIRIT and CONSORT extensions for reporting trials using surrogate endpoints as a postdoctoral researcher and is keen to see the extensions implemented to improve trial reporting, reduce research waste, and better patient care and population health.	After introducing the development of the SPIRIT\|CONSORT-Surrogate extension, the extension items to be reported for both protocols and trial reports will be presented. A rationale for reporting each item and examples of good reporting will be provided.
Ray Harris	Ray Harris is retired from a career in various statistical roles, mostly in the pharmaceutical industry. He worked across all stages of drug development. He is an honorary member of PSI and a Chartered Statistician. He continues to use his experience in a variety of volunteer roles. He is a lay member of an ethics committee and an expert member of the Oxford Primary Care Hosted Research Datasets Independent Scientific Committee. He is a PPI member in a number of groups. He has found that years of asking questions as a non-clinical member of a research team transitions very well to asking questions from a patient and public interest point of view.	From the beginning of the project patient and public involvement (PPI) was recognised as a key part of the process, engaging representatives of a key stakeholder community. The presentation will outline the PPI involvement; representing the views, interests and concerns of the public; and the benefits of PPI engagement.
Mario Ouwens	Mario Ouwens is group director in medical and statistical evidence statistics at AstraZeneca. He is co-leading the ISPOR surrogacy taskforce and has participated in the development of the CONSORT and SPIRIT extensions.	A simulation study will be presented showing that it is quite unlikely to satisfy the IQWiG rules for more chronic diseases. The impact of the following factors will be evaluated for a time-to-event late outcome and continuous early outcome: a) Trial duration b) Sample size c) Number of trials d) Variation in treatment effect on early outcome e) Rate of mortality f) Extend to which late outcome can be explained by relation between early and late outcome Treatment effect on late outcome

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