Transparency too little, too late? Why and how Health Canada should make clinical data and regulatory decision-making open to scrutiny in the face of COVID-19

Abstract:  Canada has become a global leader in publicly releasing clinical data behind therapeutic products since 2019. Disclosure of clinical data is, however, limited to the point of product approval. The COVID-19 pandemic has underscored the limitations of such a point-in-time approach to transparency. As interventions are rapidly authorized for clinical trials or clinical use through emergency mechanisms despite weak evidence of safety and effectiveness, we argue that the current level of transparency must be expanded in order to mitigate potential harms to trial participants and patients, improve the reliability of clinical trials, and ultimately preserve trust in regulatory decision-making. Using existing legal powers, we explain how the Canadian regulator can and should seek to expand data transparency by making pre-clinical studies, clinical trial protocols, informed consent forms, interim analyses, and other information transparent upstream in the research process and throughout the product’s lifecycle.