TRRU Workshop: Real World Risks

TRU Workshop: Reassessing the Governance of Clinical Trials: Preventing Real World Risks at the Gate

Program – Monday, March 9th, 2009

8h30-8h45	Welcoming remarks, Janice Graham, Canada Research Chair in Bioethics, Faculty of Medicine, Dalhousie University
	Morning Session, Session Chair: Mavis Jones, Dalhousie University
8h45-9h15	The permissive and precautionary principles in regulating clinical trial evidence for drug efficacy. John Abraham, University of Sussex Falmer (Co-author Dr. Courtney Davis)
9h15-9h25	Questions and Clarification
9h25-9h55	Issues Related to Clinical Trial Design and Practice Bob Li, Health Canada
9h55-10h05	Questions and Clarification
10h05-10h25	Transparency to enable knowledge translation of clinical trials; registration and public disclosure of their results Karmela Krleza-Jeric, Canadian Institutes of Health Research
10h25-11h00	Group Discussion / Health Break
11h00-11h30	Searching for the evidence - Trials and Tribulations. Pam McLean-Veysey, Nova Scotia Provincial Pharmacare Program and Academic Detailing
11h30-11h40	Questions and Clarification
11h40-12h10	Valuing Ambivalence – The Human Cost of Uncertainty Don Husereau, Canadian Agency for Drugs and Technologies in Health (CADTH)
12h10-12h20	Questions and Clarification
12h20-12h50	Group Discussion
12h50-14h00	Lunch – Catered in Meeting Room
	Afternoon Session, Session Chair: Amrita Mishra, Dalhousie University
14h00-14h30	Commercial confidentiality and public health. Barbara Mintzes, University of British Columbia
14h30-14h40	Questions and Clarification
14h40-15h10	The secret things belong unto the lord our God: Secrecy in pharmaceutical regulation. Joel Lexchin, York University
15h10-15h20	Questions and Clarification
15h20-16h45	Group Discussion / Health Break
16h45-17h00	Concluding Remarks, Janice Graham
	Evening Activity for All Participants
19:00	Dinner at McKelvie’s “Delishes Fishes Dishes” (1680 Lower Water Street)
21:00	Maritime Pub – The Old Triangle (5136 Prince Street)

Program – Tuesday, March 10th, 2009

8h30-8h45	Welcoming remarks, Janice Graham, Canada Research Chair in Bioethics, Faculty of Medicine, Dalhousie University
	Tuesday Session, Session Chair : Farah Huzair, Dalhousie University
8h45-9h15	Should we continue to accept analyses that favour toxic drugs over less toxic alternatives?: A systematic review of the use of Last-Observation-Carried-Forward in dementia drug RCTs Frank Molnar, Ottawa Hospital
9h15-9h25	Questions and Clarification
9h25-9h55	Theragnostics: Fusion of therapeutics and diagnostics – Will risk assessment and Communication tools from genetics age suffice for the post-genomics period? Vural Ozdemir, University of Montreal
9h55-10h05	Questions and Clarification
10h05-11h00	Group Discussion / Health Break
11h00-11h30	What if the guinea pigs who "pay the piper" called the tune? Should clinical trials give priority to the interests of their subjects, before even the interests of the trial sponsors? Tom Perry, University of British Columbia
11h30-11h40	Questions and Clarification
11h40-12h10	Why Phase III Trials Don’t Mirror Reality David Streiner, University of Toronto
12h10-12h20	Questions and Clarification
12h20-12h50	Group Discussion
12h50-14h00	Lunch – Catered in Meeting Room
14h00-15h30	Wrap-Up Discussion: Brainstorming: Workshop Dissemination? Special Issue or collection?
15h30-15h45	Concluding Remarks, Janice Graham

Workshop description

Workshop speakers

Funded by:

Situating Science: SSHRC Cluster for the Humanist and Social Studies of Science,
Nova Scotia Health Research Foundation,
Canadian Institutes of Health Research