Power Point Presentation - Overview of the Drug Safety and Effectiveness Network

[ PDF (81 KB) | Help ]

[Slide 1]

November 19, 2010

Robert Peterson, MD, PhD, MPH
Executive Director,
Drug Safety and Effectiveness Network, CIHR

[Slide 2]

Background

Evolution of knowledge about medicines demands that governments and other decision-makers seek additional evidence about the balance of benefit and harm profile throughout the product life cycle
More information is needed on safety and effectiveness of pharmaceuticals when used by diverse patient populations outside the controlled experimental environment of clinical trials
DSEN included in the Government of Canada’s Food and Consumer Safety Action Plan (December 2007) to support product life-cycle approach to drug regulation by providing additional evidence for use in ongoing risk-benefit assessment and additional tool for surveillance

[Slide 3]

Is there an “Evidence Gap”?

Evidence beyond what has been required for market authorization is often lacking at the time of drug licensing
The type of evidence to support Health Technology Assessments (HTA), payment, and informed prescribing decisions often is not developed during drug development leading to a Marketing Authorization
Evidence that is needed to determine the value of a new product within the healthcare system constitutes the evidence gap
“Substantive evidence of an effect” is not the same as “Evidence of a substantive effect”

[Slide 4]

Establishment of the DSEN

New evidence generated via the DSEN will:
- provide decision-makers with an important additional source of evidence about drug products’ safety risks relative to their therapeutic benefits
- also support decision-making on public reimbursement, and safe and optimal prescribing and use of drugs within Canada
The DSEN has three key components:
- DSEN Steering Committee (DSEN SC)
- DSEN Coordinating Office (DSEN CO) (within CIHR)
- DSEN Collaborating Centres (DSEN CCs)

[Slide 5]

[Slide 6]

Objectives of this Forum

Facilitate knowledge translation concerning the research methods applicable in the area of drug safety and comparative effectiveness
Promote interactions between researchers, policy makers, industry, and DSEN in a neutral environment
Three interactive, engaging tracks:
- Identify and examine strengths and limitations in methodologies and make recommendations to DSEN
- reports of the tracks will be given in the final plenary session

[Slide 7]

Acknowledgements

Programme Planning Committee:

Search