SYMPOSIUM: Are Randomized Trials Obsolete?
April 22, 2020
Are Randomized Trials Obsolete?
IDDI is pleased to invite you to a Symposium organized with the support from UCLouvain and EORTC
Auditorium Museum of Fine Arts and Magritte Museum – Brussels, Belgium
Wednesday, April 22, 2020
Please click on the Register here button and then select the Green Button ‘Tickets’
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.
Randomized clinical trials have often been criticized for being conducted in conditions that do not reflect the real world. There is an acute need for more and larger pragmatic trials that reflect clinical practice, but because these trials are conducted with tight budget and limited control, they are often considered as yielding unreliable or even misleading evidence of treatment benefits and harms. In addition, the recent advent of precision medicine has revived controversies about the role of randomization as a core feature in clinical trial design, for testing treatments that clearly have better efficacy than the current standards of care.
Finally, the availability of large databases of real world evidence has also led to questioning the necessity to carry out expensive and lengthy randomized clinical trials, if sophisticated statistical techniques (e.g., based on causal inference) could inform the choice between therapeutic options.
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.
|09:00 – 09:30– 09:45—————————||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|
Rue du Musée, 9 – Museumstraat 9
Entrance for the Symposium by Place du Musée – 1000 Brussels. Place du Musée is located at the end of Rue du Musée.
Train: Brussels Central station (Gare centrale)
Metro: lines 1 to 5 (Parc or Gare Centrale)
Tram: lines 92-93:(stop: Royale)
Bus: Lines 27, 38, 71 , 95 (stop: Royale)
Entrance by Place du Musée
Albertine: (Rue des Sols & Place de la Justice)
Parking 2: Portes (Rue de Namur & Blvd de Waterloo)
Parking Poelaert: (Place Poelaert)
Speaker – Moderator: Free
Please click on the Register here button then select the Green Button ‘Tickets’
Please click on the Register here button to access the registration form and then select the Green Button ‘Tickets’.