PSI Webinar: Surrogacy
This webinar will provide an overview of surrogacy for licensing and reimbursement. In turn, the need of extensions of the SPIRIT and CONSORT statement will be defined and outlined, with case studies to support.
Past PSI Events
PSI Scientific Meeting: Master Protocols - Industry, Academic, and Regulatory Perspectives
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Date: Friday 24th November 2023
Time: 09:50-17:00 GMT (registration from 09:15)
Location: Windsor Rooms, Johnson & Johnson, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG
Speakers: Julia Saperia (MHRA), Kim Lee (Kings College London), Tobias Mielke (Janssen), David Robertson (MRC Biostatistics Unit), Luke Ouma (Newcastle Universit), Elias Meyer (Berry Consultants), Adrian Mander (GSK), Vincent Haddad (AstraZeneca), Cindy Billingham (Birmingham University), and Willem Talloen (Janssen).
Who is this event intended for? All parties interested in the use of master protocols in clinical research, in particular but not only statisticians.
What is the benefit of attending? This one-day event will establish a forum to engage with colleagues from a diverse range of backgrounds who are actively working on effective master protocol design, analysis, and execution. It will provide the opportunity to learn much about the current landscape of master protocol use.
Overview
This meeting will bring together cross-sector researchers to provide talks on innovative methodology for the design and analysis of basket, umbrella, and platform trials. Additional presentations will address learnings from practical examples of master protocols and regulatory opinions on their implementation.
Speaker details
Our Speaker line-up is featured below, but you can also download a full overview of the event Agenda, Speaker Biographies, Speaker Abstracts and travel details which have been compiled into a single PDF for ease. Please click below to view or download a copy for more information.
Event PDF: Master Protocols - Overview
Speaker Presentations
Some of our esteemed panel have kindly shared their Presentations following this event, most of which you can find below.
1. Cindy Billingham - Platform trials for rare cancers
2. David Robertson - Online error rate control for platform trials
3. Elias Laurin Meyer - Using simulations for designing platform trials
4. Kim Lee - The caveats in the analysis of platform trials
5. Luke Ouma - Bayesian modelling strategies for borrowing of information in randomised basket trials
6. Max Parmar - Multi-arm multi-stage platform trials
7. Tobias Mielke - On the complexity of independent decision making in platform trials
PSI Scientific Meeting: Master Protocols - Industry, Academic, and Regulatory Perspectives
Add to:
Date: Friday 24th November 2023
Time: 09:50-17:00 GMT (registration from 09:15)
Location: Windsor Rooms, Johnson & Johnson, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG
Speakers: Julia Saperia (MHRA), Kim Lee (Kings College London), Tobias Mielke (Janssen), David Robertson (MRC Biostatistics Unit), Luke Ouma (Newcastle Universit), Elias Meyer (Berry Consultants), Adrian Mander (GSK), Vincent Haddad (AstraZeneca), Cindy Billingham (Birmingham University), and Willem Talloen (Janssen).
Who is this event intended for? All parties interested in the use of master protocols in clinical research, in particular but not only statisticians.
What is the benefit of attending? This one-day event will establish a forum to engage with colleagues from a diverse range of backgrounds who are actively working on effective master protocol design, analysis, and execution. It will provide the opportunity to learn much about the current landscape of master protocol use.
Overview
This meeting will bring together cross-sector researchers to provide talks on innovative methodology for the design and analysis of basket, umbrella, and platform trials. Additional presentations will address learnings from practical examples of master protocols and regulatory opinions on their implementation.
Speaker details
Our Speaker line-up is featured below, but you can also download a full overview of the event Agenda, Speaker Biographies, Speaker Abstracts and travel details which have been compiled into a single PDF for ease. Please click below to view or download a copy for more information.
Event PDF: Master Protocols - Overview
Speaker Presentations
Some of our esteemed panel have kindly shared their Presentations following this event, most of which you can find below.
1. Cindy Billingham - Platform trials for rare cancers
2. David Robertson - Online error rate control for platform trials
3. Elias Laurin Meyer - Using simulations for designing platform trials
4. Kim Lee - The caveats in the analysis of platform trials
5. Luke Ouma - Bayesian modelling strategies for borrowing of information in randomised basket trials
6. Max Parmar - Multi-arm multi-stage platform trials
7. Tobias Mielke - On the complexity of independent decision making in platform trials
PSI Scientific Meeting: Master Protocols - Industry, Academic, and Regulatory Perspectives
Add to:
Date: Friday 24th November 2023
Time: 09:50-17:00 GMT (registration from 09:15)
Location: Windsor Rooms, Johnson & Johnson, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG
Speakers: Julia Saperia (MHRA), Kim Lee (Kings College London), Tobias Mielke (Janssen), David Robertson (MRC Biostatistics Unit), Luke Ouma (Newcastle Universit), Elias Meyer (Berry Consultants), Adrian Mander (GSK), Vincent Haddad (AstraZeneca), Cindy Billingham (Birmingham University), and Willem Talloen (Janssen).
Who is this event intended for? All parties interested in the use of master protocols in clinical research, in particular but not only statisticians.
What is the benefit of attending? This one-day event will establish a forum to engage with colleagues from a diverse range of backgrounds who are actively working on effective master protocol design, analysis, and execution. It will provide the opportunity to learn much about the current landscape of master protocol use.
Overview
This meeting will bring together cross-sector researchers to provide talks on innovative methodology for the design and analysis of basket, umbrella, and platform trials. Additional presentations will address learnings from practical examples of master protocols and regulatory opinions on their implementation.
Speaker details
Our Speaker line-up is featured below, but you can also download a full overview of the event Agenda, Speaker Biographies, Speaker Abstracts and travel details which have been compiled into a single PDF for ease. Please click below to view or download a copy for more information.
Event PDF: Master Protocols - Overview
Speaker Presentations
Some of our esteemed panel have kindly shared their Presentations following this event, most of which you can find below.
1. Cindy Billingham - Platform trials for rare cancers
2. David Robertson - Online error rate control for platform trials
3. Elias Laurin Meyer - Using simulations for designing platform trials
4. Kim Lee - The caveats in the analysis of platform trials
5. Luke Ouma - Bayesian modelling strategies for borrowing of information in randomised basket trials
6. Max Parmar - Multi-arm multi-stage platform trials
7. Tobias Mielke - On the complexity of independent decision making in platform trials
PSI Scientific Meeting: Master Protocols - Industry, Academic, and Regulatory Perspectives
Add to:
Date: Friday 24th November 2023
Time: 09:50-17:00 GMT (registration from 09:15)
Location: Windsor Rooms, Johnson & Johnson, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG
Speakers: Julia Saperia (MHRA), Kim Lee (Kings College London), Tobias Mielke (Janssen), David Robertson (MRC Biostatistics Unit), Luke Ouma (Newcastle Universit), Elias Meyer (Berry Consultants), Adrian Mander (GSK), Vincent Haddad (AstraZeneca), Cindy Billingham (Birmingham University), and Willem Talloen (Janssen).
Who is this event intended for? All parties interested in the use of master protocols in clinical research, in particular but not only statisticians.
What is the benefit of attending? This one-day event will establish a forum to engage with colleagues from a diverse range of backgrounds who are actively working on effective master protocol design, analysis, and execution. It will provide the opportunity to learn much about the current landscape of master protocol use.
Overview
This meeting will bring together cross-sector researchers to provide talks on innovative methodology for the design and analysis of basket, umbrella, and platform trials. Additional presentations will address learnings from practical examples of master protocols and regulatory opinions on their implementation.
Speaker details
Our Speaker line-up is featured below, but you can also download a full overview of the event Agenda, Speaker Biographies, Speaker Abstracts and travel details which have been compiled into a single PDF for ease. Please click below to view or download a copy for more information.
Event PDF: Master Protocols - Overview
Speaker Presentations
Some of our esteemed panel have kindly shared their Presentations following this event, most of which you can find below.
1. Cindy Billingham - Platform trials for rare cancers
2. David Robertson - Online error rate control for platform trials
3. Elias Laurin Meyer - Using simulations for designing platform trials
4. Kim Lee - The caveats in the analysis of platform trials
5. Luke Ouma - Bayesian modelling strategies for borrowing of information in randomised basket trials
6. Max Parmar - Multi-arm multi-stage platform trials
7. Tobias Mielke - On the complexity of independent decision making in platform trials
PSI Scientific Meeting: Master Protocols - Industry, Academic, and Regulatory Perspectives
Add to:
Date: Friday 24th November 2023
Time: 09:50-17:00 GMT (registration from 09:15)
Location: Windsor Rooms, Johnson & Johnson, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG
Speakers: Julia Saperia (MHRA), Kim Lee (Kings College London), Tobias Mielke (Janssen), David Robertson (MRC Biostatistics Unit), Luke Ouma (Newcastle Universit), Elias Meyer (Berry Consultants), Adrian Mander (GSK), Vincent Haddad (AstraZeneca), Cindy Billingham (Birmingham University), and Willem Talloen (Janssen).
Who is this event intended for? All parties interested in the use of master protocols in clinical research, in particular but not only statisticians.
What is the benefit of attending? This one-day event will establish a forum to engage with colleagues from a diverse range of backgrounds who are actively working on effective master protocol design, analysis, and execution. It will provide the opportunity to learn much about the current landscape of master protocol use.
Overview
This meeting will bring together cross-sector researchers to provide talks on innovative methodology for the design and analysis of basket, umbrella, and platform trials. Additional presentations will address learnings from practical examples of master protocols and regulatory opinions on their implementation.
Speaker details
Our Speaker line-up is featured below, but you can also download a full overview of the event Agenda, Speaker Biographies, Speaker Abstracts and travel details which have been compiled into a single PDF for ease. Please click below to view or download a copy for more information.
Event PDF: Master Protocols - Overview
Speaker Presentations
Some of our esteemed panel have kindly shared their Presentations following this event, most of which you can find below.
1. Cindy Billingham - Platform trials for rare cancers
2. David Robertson - Online error rate control for platform trials
3. Elias Laurin Meyer - Using simulations for designing platform trials
4. Kim Lee - The caveats in the analysis of platform trials
5. Luke Ouma - Bayesian modelling strategies for borrowing of information in randomised basket trials
6. Max Parmar - Multi-arm multi-stage platform trials
7. Tobias Mielke - On the complexity of independent decision making in platform trials
PSI Scientific Meeting: Master Protocols - Industry, Academic, and Regulatory Perspectives
Add to:
Date: Friday 24th November 2023
Time: 09:50-17:00 GMT (registration from 09:15)
Location: Windsor Rooms, Johnson & Johnson, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG
Speakers: Julia Saperia (MHRA), Kim Lee (Kings College London), Tobias Mielke (Janssen), David Robertson (MRC Biostatistics Unit), Luke Ouma (Newcastle Universit), Elias Meyer (Berry Consultants), Adrian Mander (GSK), Vincent Haddad (AstraZeneca), Cindy Billingham (Birmingham University), and Willem Talloen (Janssen).
Who is this event intended for? All parties interested in the use of master protocols in clinical research, in particular but not only statisticians.
What is the benefit of attending? This one-day event will establish a forum to engage with colleagues from a diverse range of backgrounds who are actively working on effective master protocol design, analysis, and execution. It will provide the opportunity to learn much about the current landscape of master protocol use.
Overview
This meeting will bring together cross-sector researchers to provide talks on innovative methodology for the design and analysis of basket, umbrella, and platform trials. Additional presentations will address learnings from practical examples of master protocols and regulatory opinions on their implementation.
Speaker details
Our Speaker line-up is featured below, but you can also download a full overview of the event Agenda, Speaker Biographies, Speaker Abstracts and travel details which have been compiled into a single PDF for ease. Please click below to view or download a copy for more information.
Event PDF: Master Protocols - Overview
Speaker Presentations
Some of our esteemed panel have kindly shared their Presentations following this event, most of which you can find below.
1. Cindy Billingham - Platform trials for rare cancers
2. David Robertson - Online error rate control for platform trials
3. Elias Laurin Meyer - Using simulations for designing platform trials
4. Kim Lee - The caveats in the analysis of platform trials
5. Luke Ouma - Bayesian modelling strategies for borrowing of information in randomised basket trials
6. Max Parmar - Multi-arm multi-stage platform trials
7. Tobias Mielke - On the complexity of independent decision making in platform trials
