Adaptive Platform Trials Scientific Meeting
October 3, 2024
Chestnut Conference Centre, Toronto, ON, Canada
Objectives
Implementation
Understand the key elements of designing and implementing adaptive platform trials.
Operation
Gain insights into the operational aspects of adaptive platform trials, such as protocol development, CRF design, data management, and the role of standardization and operational documents.
Analysis
Understand the importance of pre-trial model-based simulations and interim statistical analyses for adaptive platform trials.
Ethics Approval
Learn about the ethical considerations, best practices, and the role of Research Ethics Boards in operationalizing ethical guidelines throughout adaptive platform trials.
Engagement
Explore strategies for effective engagement and involvement of participants, including patients and other stakeholders, in the adaptive platform trial process.
Networking
Connect and learn with experts, researchers, professionals, and trainees working on adaptive platform trials.
Agenda
Registration and Welcome
Registration opens
Light breakfast will be provided
Welcome and introduction
Drs. Benita Hosseini and Andrew Pinto
APT Design
Overview of the basics of adaptive platform trials (APTs) and suitable questions for an APT
Dr. John Marshall
How to design an adaptive platform trial
Platform structure (includes defining treatment arms, assessing patient eligibility status, and identifying patient characteristics or biomarkers that form the basis for stratification into subgroups)
The role of simulation in planning (how simulations are used to predict trial outcomes, optimize design parameters, and prepare for adaptive decision-making processes within the trial)
Dr. Ben Saville
Algorithms and methodologies for the analysis of data generated by adaptive trials
Dr. Lorenzo Trippa
Panel discussion: Lessons from previous APTs
Chair/Moderator: Dr. John Marshall
Panelists: Drs. John Marshall, Niall Ferguson, Lorenzo Trippa, and Ben Saville
Lunch and Networking
Lunch will be provided
APT Operations
Operational aspects of adaptive platform trials
- Registering your trial
- Modular approach to protocol (master protocol & sub-protocols)
- Research coordinator perspective – challenges and solutions – Importance of standardization, role of operational documents and SOPs
- Data management, especially dynamic aspects
- Management, governance, site contracts
Dr. Francesca Schiavone
Panel discussion: Reflect on real-world challenges in the operational aspects of APTs and discuss strategies to address them)
Chair/Moderator: Dr. Andrew Pinto
Panelists: Drs. Francesca Schiavone, John Marshall, Niall Ferguson, Benita Hosseini, Lorenzo Trippa, and Ben Saville
APT Implementation
Interactive mock REB meeting
Participants will review a short proposal idea for an adaptive platform trial, discuss it in the context of research ethics, and provide feedback
Dr. Ross Upshur
Click here to access the draft protocol that will be used during this session.
Transparent consent in APTs
Explaining APTs to patients and truly informed consent
Dr. Jarome Singh
Participant engagement and implementing Good Participatory Practices in APTs
Dr. Lisa Schwartz
Dr. Andrew Pinto
Drs. Benita Hosseini and Andrew Pinto
Reception and Networking
Light refreshments will be provided
Meet the speakers
Dr. Andrew Pinto
Upstream Lab
Dr. Ben Saville
Adaptix Trials, LLC
Ben Saville, PhD, is President and Lead Statistical Scientist of Adaptix Trials, LLC, where he specializes in the design of innovative Bayesian and adaptive clinical trials. He works primarily with medical device and pharmaceutical companies to solve challenging problems via Bayesian designs. Dr. Saville has designed Bayesian clinical trials in a variety of therapeutic areas, including cardiovascular diseases, rare and progressive diseases, infectious diseases, stroke and traumatic brain injury, respiratory and digestive disorders, and neurological diseases. Dr. Saville is a frequent invited speaker at statistical conferences, academic seminars, and lecture series, including short courses on Bayesian adaptive clinical trial design and platform trials. Dr. Saville has authored over 100 peer-reviewed publications in the statistical and medical literature, with expertise in Bayesian hierarchical models and Bayesian adaptive platform trial designs.
Dr. Benita Hosseini
Upstream Lab
Dr. Francesca Schiavone
University College London
Francesca Schiavone, PhD, is based at the Medical Research Council Clinical Trials Unit (MRC CTU) at University College London, overseeing the planning and conduct of international clinical trials, particularly in the resource-limited settings. Since joining the MRC CTU in 2012, she has worked on several adaptive platform trials in oncology and infectious diseases. Working on adaptive platform designs has given her unique opportunities to learn the operational complexities and challenges of trial conduct that come with novel trial designs. She is currently involved with the set-up and conduct of two large international trials utilising a PRACTical design. Francesca also is involved in the MSc in Clinical Trials run by the Institute of Clinical Trials and Methodology (ICTM), teaching on the practicalities of trial set up and applying the principles of clinical trials into practice. Francesca is a member of the MRC-NIHR Trials Methodology Research Partnership (TMRP) working group on data quality and monitoring and a protocol editor at Trials.
Dr. Jerome Singh
University of KwaZulu-Natal
Dr. John Marshall
St. Michael’s Hospital
Dr. Lisa Schwartz
McMaster University
Lisa Schwartz, MA PhD, is the Arnold L. Johnson Chair in Health Care Ethics, a co-lead on a program of research on humanitarian health ethics, and a Professor in the Department of Health Research Methods, Evidence & Impact at McMaster University. Dr. Schwartz’s research background is in ethics and human research, evaluation of ethics education in medicine, and advocacy in health care. Dr Schwartz provided the World Health Organization with support on Good Participatory Practices for a global adaptive platform trial.
Dr. Lorenzo Trippa
Harvard University
Lorenzo Trippa, PhD, is a Professor in the Department of Biostatistics and Computational Biology at Dana-Farber, and a Professor in the Department of Biostatistics at the Harvard T.H. Chan School of Public Health. His research interests include clinical trials design; Bayesian nonparametrics; the development of prediction models in personalized medicine; computational methods for Bayesian adaptive designs; computational methods for Bayesian inference; and meta-analyses in personalized medicine. Trippa is a winner of the Savage PhD Thesis Award from the International Society for Bayesian Analysis. He holds a PhD in Statistics from Bocconi University, Milan, Italy, and an MS in Statistics (cum laude) from Milan’s Bicocca University.
Dr. Niall Ferguson
University of Toronto
Dr. Ross Upshur
University of Toronto
Ross Upshur, MD MA MSc MCFP FRCPC FCAHS, is the Dalla Lana Chair in Clinical Public Health, Professor and Head of the Division of Clinical Public Health at the Dalla Lana School of Public Health and Professor in the Department of Family and Community Medicine in the Temerty Faculty of Medicine, University of Toronto. He is the Associate Director of the Collaborative Centre for Climate, Heath and Sustainable Care.
Scientific Committee
Benita Hosseini
CHAIR
PhD MSc
Andrew Pinto
MD CCFP FRCPC MSc
Lisa Schwartz
MA PhD
Robert Fowler
MDCM MSc
Shirin Golchi
PhD MSc
Learn. Connect. Transform.
The APT Scientific Meeting is for clinical trialists, clinical investigators, statisticians, trial methodologists, health economists, policymakers, patient advocates, and trainees interested in the use, design and implementation of platform trials.
Sponsors and Supporters
The Upstream Lab is organizing the 2024 Adaptive Platform Trials Scientific Meeting. This non-profit research group, based at the MAP Centre for Urban Health Solutions, St. Michael’s Hospital, is dedicated to improving the health and well-being of the population by addressing social determinants of health, using artificial intelligence, and conducting trials.
Get in touch
Questions? Contact info@cantreatcovid.org
Date: October 3, 2024
Time: 9:00 am to 5:00 pm
Location:
University Room – 3rd Floor
Chestnut Conference Centre
89 Chestnut St
Toronto, ON M5G 1R1
We acknowledge that this event is happening on the traditional territory of many nations including the Mississaugas of the Credit, the Anishnabeg, the Chippewa, the Haudenosaunee, and the Huron-Wendat peoples and is now home to many diverse First Nations, Inuit, and Métis. We also acknowledge that Toronto is covered by Treaty 13 with the Mississaugas of the Credit.
The APT Scientific Meeting is for clinical trialists, clinical investigators, statisticians, trial methodologists, health economists, trainees, policymakers, patient advocates, and anyone interested in the use, design and implementation of platform trials.
We appreciate your interest in contributing to the conference. Please contact our organizing committee at info@cantreatcovid.org to inquire about speaking at the APT Scientific Meeting. We welcome diverse perspectives and expertise.
Yes, the APT Scientific Meeting will be available online for virtual attendance. Virtual attendees will have access to live and recorded sessions and the ability to participate in Q&A sessions.
