Real World Risks
CIHR Meetings, Planning & Dissemination Grant (2009)
The mood for regulation is shifting. The global collapse of free market forces has brought into question the wisdom of a deregulated marketplace, and regulatory debates are moving back to the language of command and control. The implications of this are unfolding at a time when, in Canadian health policy at least, risk governance has been built on the philosophy of getting the drug to the consumer faster. Health Canada has been advancing a flexible, “smart” and progressive post-market regulatory framework to streamline health product evaluation. There is, as a consequence, less scope to identify a product’s risks before it hits the market; risks are now increasingly located in uncontrolled public spaces, rather than controlled experimental ones. Much attention has turned to real-world risks and to the development of tools for regulatory oversight of products already on the market.
Our workshop proposes to step back to examine the pre-market regulatory context. Clinical trials are the gold standard of evidence in regulation; but clinical trial results frequently provide inadequate information on the safety and efficacy of drugs. This two-day workshop will critically assess the failure of clinical research to address the space between efficacy and effectiveness of therapeutic products. We are interested in how particular knowledge producers and users make decisions, the influence of contextual factors on decision-making, and the synthesis of knowledge for evidence-based improvements in practice or policy. The aim of the workshop is to gather together clinical researchers, regulators, health technology experts, policy makers, patients, and health care providers to identify and discuss the fault lines in existing clinical trial research and regulatory approval processes. We propose to develop a preliminary framework to serve as a guide for clinical trials, to guard against conflicts of interest and insufficient data that currently undermine the production and assessment of evidence for the safety, quality, efficacy and effectiveness of therapeutic products.