Thursday, 5 October 2023 | 5pm CEST | 4pm BST | 11am EST
Live debate on RWE vs RCTs
by leading Professors from Harvard, Oxford, London
“When can RWE be relied on to complement or replace evidence from RCTs to guide clinical decisions?”
REGISTER HEREAbout this event
TITLE: When can real world evidence be relied on to complement or replace evidence from randomized trials to guide clinical decisions
DATE: October 5, 2023, at 5pm CEST | 4pm BST | 11am EST.
FORMAT: Free live online webinar. This webinar will not be recorded.
TARGET AUDIENCE: people who plan, conduct, request, sponsor or evaluate comparative studies, be they trials or observational: regulators, HTAs, industry, grant awarding bodies, journals and academic researchers.
Real world evidence (RWE) is being increasingly used to assess the effectiveness and safety of medications and devices. The results from comparisons of RWE and RCTs for the effectiveness of drugs is being taken up by US and European regulators and reimbursement agencies.
We bring together a panel of leading epidemiologists and trialists to consider to what extent and where RWE can be trusted to complement or replace randomized evidence to guide clinical decisions.
The purpose of the event is to have a debate with two leading proponents who believe that observational studies can provide evidence on effectiveness and safety that is sufficiently reliable to guide clinical decisions and two critics of this approach. There will then be discussion among the speakers and questions from the virtual audience.
The debate will focus on the following areas:
1
When observational studies
may be helpful.
2
When randomized trials
are necessary.
3
When observational studies and randomized trials can complement each other.
4
How randomized trials can be made more relevant to real world clinical practice.
Agenda
– INTRODUCTION BY MODERATOR
Nawab Qizilbash, Senior Clinical Epidemiologist, OXON Epidemiology
Hon. Assoc. Professor, London School of Hygiene and Tropical Medicine; former Hon. Consultant Physician, Oxford.
– 15-MINUTE SPEAKERS PRESENTATIONS
Miguel Hernán, Professor of Epidemiology and Biostatistics, Harvard
A leading epidemiologist whose CAUSALab group has developed causal inference methods and published multiple comparisons of RWD and randomized trials.
Martin Landray, Professor of Medicine and Epidemiology, Oxford
A leading trialist and epidemiologist whose general position on this topic is captured by his NEJM sounding board article (2020): ´ The Magic of Randomization versus the Myth of Real-World Evidence´.
Sebastian Schneeweiss, Professor of Medicine and Epidemiology, Harvard Medical School
A leading epidemiologist whose group, with the participation of FDA scientists, attempted to emulate 30 completed trials and predict the outcome of 7 ongoing trials using real-world data at scale, applying a prespecified approach.
Stuart Pocock, Professor of Medical Statistics, London School of Hygiene and Tropical Medicine
A leading trialist whose general position on this topic is captured by his NEJM editorial (2000) ‘Randomized Trials or Observational Tribulations?’
– DISCUSSION BETWEEN THE SPEAKERS: 20 MINUTES
– Q & A FROM AUDIENCE TO SPEAKERS: 10 MINUTES
The speakers
None of the speakers have a relationship with OXON, except Stuart Pocock.
All speakers volunteer their time for this event as a service to health researchers and regulators.
MIGUEL
HERNÁN
Professor of Epidemiology and Biostatistics, Harvard
A leading epidemiologist whose CAUSALab group has developed causal inference methods and published multiple comparisons of RWD and randomized trials.
ACADEMIC PROFILEMARTIN
LANDRAY
Professor of Medicine and Epidemiology, Oxford
A leading trialist and epidemiologist whose general position on this topic is captured by his NEJM sounding board article (2020): ‘The Magic of Randomization versus the Myth of Real-World Evidence´
ACADEMIC PROFILESEBASTIAN SCHNEEWEISS
Professor of Medicine and Epidemiology, Harvard Medical School
A leading epidemiologist whose group, with the participation of FDA scientists, attempted to emulate 30 completed trials and predict the outcome of 7 ongoing trials using real-world data at scale, applying a prespecified approach.
ACADEMIC PROFILESTUART
POCOCK
Professor of Medical Statistics, London School of Hygiene and Tropical Medicine
A leading trialist whose general position on this topic is captured by his NEJM editorial (2000) ´ Randomized Trials or Observational Tribulations?
ACADEMIC PROFILEDR NAWAB
QIZILBASH
Senior Clinical Epidemiologist, OXON
Honorary Associate Professor, London School of Hygiene and Tropical Medicine and former Honorary Consultant Physician, Oxford
PROFILEHow to attend
Anyone interested in learning on RCTs and observational studies is welcome
This open debate is addressed to people who plan, conduct, request, sponsor or evaluate comparative studies, be they trials or observational: regulators, HTAs, industry, grant awarding bodies, journals and academic researchers.
Registration will remain open until all of the available seats are filled.
1
REGISTER
Click on any of the REGISTER buttons on this page to access the registration form for the event. Once you fill it out and press send, you will receive in the email address provided the confirmation with the link to join the event.
2
JOIN THE SESSION
One day before the event you will receive a kind reminder containing again the link to join the event. You can join with your computer or mobile device. No need to use any downloaded software. Just join the webcast and enjoy!
3
PARTICIPATE!
The last 10 minutes of the debate are reserved to answer the audience questions.
Please use the Questions panel of the platform for your queries at any time during the event.