PSI Webinar: Surrogacy

PSI Introduction to Industry Training (ITIT) Course - 2026/2027

An introductory course giving an overview of the pharmaceutical industry and the drug development process as a whole, aimed at those with 1-3 years' experience. It comprises of six 2-day sessions covering a range of topics including Research and Development, Toxicology, Data Management and the Role of a CRO, Clinical Trials, Reimbursement, and Marketing.

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

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, “Graphics Basics,” will introduce the fundamentals of producing graphics using the ggplot2 package.

PSI Career Young Virtual Event (Q2 2026)

This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.

PSI Book Club: The AI Con – Joint with ASA Book Club

The Guardian described the authors of this book as refreshingly sarcastic! What is sold to us as AI, they announce, is just "a bill of goods": "A few major well-placed players are poised to accumulate significant wealth by extracting value from other people's creative work, personal data, or labour, and replacing quality services with artificial facsimiles."

Causal Inference SIG and EFSPI Methods Leaders: Modern Covariate Adjustment in Clinical Trials

This webinar will discuss modern approaches to covariate adjustment in clinical trials. We begin with the motivation and key principles underlying the FDA guidance, then revisit established methodologies in light of these regulatory considerations. Building on this foundation, we explore extensions to more advanced applications in clinical trial analysis. The webinar concludes with an outlook on future developments and a panel discussion.

PSI Book Club: Another Door Opens – Book Club Special Event

This is a Book Club Special Event in response to the changes in our industry and as a supportive move to create community and connection for those navigating redundancy and uncertainty. Read the book in advance of the book club session then join the zoom call to discuss ideas. There will be breakout groups to connect with others, exchange experiences of how the book has helped, and offer support.

PSI Book Club: Change: How organisations achieve hard-to-image results in uncertain and volatile times

Organizations have to adapt to the transforming landscape of our industry to ensure they continue to be successful in the future. Many of us are feeling the impact of organizational change. By reading John P Kotter’s book we can understand about organizational change and learn how to thrive, rather than just survive, through change. Change, by John P Kotter (and his team), is a summary of all that he has learned over his decades of research and leading change. His book describes why many current approaches to change are inadequate and explains why new solutions need to give people a voice and a role in a new, change-embracing organization. Develop your understanding of organisational change and become empowered to be part of your organisation’s change, by reading Change by John P Kotter and joining the Sept-Dec 2025 book club. You will be invited to join facilitated discussions of the concepts and ideas and apply knowledge from the book in-between sessions.

PSI Career Young Virtual Event (Q3 2026)

This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.

PSI Training Course: Propensity Scores: Practical Application in Non-randomised Studies

The course will introduce the topic of propensity scores and the use of external data. Covering the topics of matching and weighting as well as more advance topics of high dimension propensity scores, multi-valued treatments, double robustness and time-varying scenarios. There will be the opportunity to participate in some hands on practical exercises in R.

PSI Career Young Virtual Event (Q4 2026)

This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.

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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