OUTLINE:
April 2020 will mark the 40th anniversary of Jay Herson’s paper “Patient Registration in a Cooperative Oncology Group”. That paper, published in the first volume of the journal Controlled Clinical Trials, dealt with sources of bias and randomization practices that existed at the time. Looking back, it is surprising to see how much has changed since 1980. Whilst randomization remains a key design feature for confirmatory trials aimed at new drug approval, many innovative non-randomized study designs have been proposed and used in recent years.
This symposium will address the sources of bias that continue to threaten sound clinical research now and in the foreseeable future. Past achievements and the current landscape will be described along with realistic proposals to move the field forward. Read Symposium outline here.
CLICK ON THE GREEN BUTTON 'TICKET' TO REGISTER.
AGENDA
09:00 - 09:30 – Welcome and Registration
09:30 – 09:45 – Opening remarks – Marc Buyse, IDDI and U Hasselt, Belgium
Session 1 Laurence Collette, EORTC, Belgium, Moderator
09:45 – 10:20 – KEYNOTE TALK 1: Bias and randomization: 1980 – 2020 – 2060 – Jay Herson, Johns Hopkins U, Baltimore, MD, USA
10:20 – 10:45 – Innovative trial designs with and without randomization – François Beckers, Merck, Germany
10:45 – 11:15 – Coffee break
11:15 – 11:40 – Does precision medicine need randomized trials? – Everardo Saad, IDDI, Belgium
11:40 – 12:05 – Can causal inference ever replace randomization? – Johan Steen, U Ghent, Belgium
12:05 – 12:30 – Q & A and discussion – Moderator and panelists
12:30 – 13:45 – Lunch break
Session 2 Catherine Legrand, UCLouvain, Belgium, Moderator
13:45 – 14:20 – KEYNOTE TALK 2: SOCRATES and the need for big randomized data – John Simes, NHMRC Clinical Trials Centre, Sydney, Australia
14:20 – 14:45 – Pragmatic randomized trials – Frank Hulstaert, KCE, Belgium
14:45 – 15:15 – Coffee break
Session 3 Bart Spiessens, Janssen R&D, Belgium, Moderator
15:15 – 15:50 – KEYNOTE TALK 3: Real-world evidence in medicines development and regulatory affairs: Applications and future directions – John O’Donnell, Bristol-Myers Squibb, Princeton, NJ, USA
15:50 – 16:15 – The promise and perils of real-world evidence and big data – Tomasz Burzykowski, IDDI and U Hasselt, Belgium
16:15 – 16:40 – Q & A and discussion – Moderators and panelists
17:00 – 19:00 – Networking Reception
We look forward to welcoming you!
The IDDI Team
