DataNB
The latest from the New Brunswick Institute for Research, Data and Training

Clinical trials are a critical element of pharmaceutical safety and effectiveness, providing essential information about their effects, and side effects, in a variety of circumstances. The positive impact of clinical trials can often come with limitations, however. Are there long-term effects beyond the duration of the trial? Does the drug in question function differently in the real world, outside of a controlled environment? What are the potential impacts on individuals with multiple health issues? Or members of marginalized or equity-seeking groups? These are all questions which Real World Evidence (RWE) can help answer.

As with any tool meant to guide and instruct practices, they need guidelines, wise practices and minimum requirements to be reliable and maintain integrity. Canada’s Drug and Health Technology Agency (CADTH), Health Canada and the Institut national d’excellence en santé et en services sociaux (INESSS) are at the center of helping to direct how RWE studies are reported. In response to this need, the RWE Steering Committee included panelists and data experts from across Canada to inform the newly released framework for RWE to be used in regulatory and decision-making bodies within Canada.

Among the working group members for this report was NB-IRDT Director, Dr. Ted McDonald. According to Dr. McDonald, “This is a crucial step for data-informed decision making that establishes best practices and recommended minimum standards for real world evidence studies. This will benefit not only New Brunswickers, but Canadians in general by facilitating the take-up of rigorous research on the real world effectiveness of prescribed drugs.”