Inaugural Course on Osteoarthritis Clinical Trials
*Ticketed session, limited space available. For more information, click on the session title.
Timeslot: Wednesday, April 26, 2017 - 11:00am to 8:00pm
Historically there have been a number of clinical trials run by both industry and academic investigators, however we have yet to see a novel therapeutic or device successfully attain regulatory approval for disease modification in this important, medically challenging arena. This course is therefore an approach by OARSI to equip investigators and industry sponsors to understand the complexities of running patient-oriented randomized clinical trials in osteoarthritis.
This course is designed to provide valuable insight and information to those wishing to participate in multi-center clinical trials with the biopharmaceutical industry as well as those planning to design and conduct investigator-initiated randomized controlled trials, either as a single center or in multi-center setting. Highly esteemed faculty has been selected by the Planning Committee from across academia and industry to provide this instructive, in-depth and focused course, where delegates will come out with a greater understanding and ability to design and conduct successful clinical trials in the patient population with osteoarthritis.
We hope you will consider joining us for this inaugural course which we anticipate will become one of the annual highlights in the OARSI calendar.
11:00am—12:00pm Introduction to RCT in OA (Dorothy Dunlop, Northwestern University)
12:10—12:25pm Patient Voices in OA Trials (Amanda Niskar, AF)
12:25 —12:45pm Introduction & Overview (Elena Losina, Brigham and Women’s Hospital, Harvard Medical School)
12:45pm—2:00pm Inflammatory and Bone Phenotypes in OA –Challenges and Opportunities in Pharmacologic RCTs
12:45—1:15pm Inflammatory (Jeroen Medema, Abbvie)
1:15—1:45pm Bone (Virginia Kraus, Duke University)
1:45—2:00pm Discussion (Moderator Christoph Ladel, Merck)
2:00pm—3:45pm Outcomes in OA RCTs Focused on Inflammatory and Bone Phenotype
2:00—2:20pm Biochemical Soluble Markers (Ali Mobasheri, University of Nottingham)
2:20—2:40pm Imaging Markers (Xiaojuan Li, UCSF)
2:50—3:10pm Performance-based Outcomes (Kim Bennell, University of Melbourne)
3:10—3:30pm Patient Outcomes in OA Trials (Jeffrey Katz, Brigham and Women’s Hospital, Harvard Medical School)
3:30—3:45 pm Discussion (Moderator Natalie Collins)
3:45pm—4:30pm Breakout Groups (Inflammatory or Bone Phenotypes)
Group discussion to focus on selection of primary and secondary outcomes measures, timing of assessment. Assessing whether the phenotype is ‘ready’ for Phase III RCT (assuming there is an appropriate candidate drug).
4:35—5:00pm Breakout Group Summary Discussion (Moderator Ida Haugen, Diakonhjemmet Hospital, Norway)
5:00—6:00pm Role of Placebo
5:00—5:20pm Theoretical Underpinning of the Placebo (Weiya Zhang, University of Nottingham)
5:20—5:40pm Placebo Effect in OA Trials (Asger Bihlet, Nordic Bioscience)
5:40—6:00pm Discussion (Moderator Elena Losina)
6:00—6:10pm Dinner Goals Discussion
Each table will be given (randomly) a specific ‘regimen’, phenotype and will discuss over the dinner the role of the placebo for the given combination of phenotype and ‘regimen’.
6:00—7:30pm Working Dinner
7:30—8:00pm Concluding Session
Each group presents their ‘case’ on the role of specific outcome or placebo.
Speakers to include:
Dorothy Dunlop, PhD
Amanda Niskar, DrPH, MPH, BSN
Elena Losina, PhD
Virginia Kraus, MD, PhD
Christoph Ladel, PhD
Ali Mobasheri, BSc, ARCS (Hons), MSc, DPhil
Xiaojuan Li, PhD
Kim Bennell, PhD, PT
Jeffrey Katz, MD,MS
Natalie Collins, PhD, PT
Ida Haugen, MD
Weiya Zhang, MSc, PhD
Asger Bihlet, MSc, Pharm
Regular Member/Non-Member: $250
Student/Associate Member/Non-Member: $150