How to use the regulatory data from Health Canada for secondary analyses on new drugs, biologics and vaccines.
Isaac BaiPeter DoshiMatthew HerderPublished in: BMJ evidence-based medicine (2023)
Incorporating clinical data held by national health product regulatory authorities into secondary analyses such as systematic reviews can help combat publication bias and selective outcome reporting, in turn, supporting more evidence-based decisions regarding the prescribing of drugs, biologics and vaccines. Owing to recent changes in Canadian law, Health Canada has begun to make clinical information-whether it has been previously published or not-publicly available through its 'Public Release of Clinical Information' (PRCI) online database. We provide guidance about how to access and use regulatory data obtained through the PRCI database for the purpose of conducting drug and biologic secondary analyses.
Keyphrases
- health information
- adverse drug
- healthcare
- electronic health record
- public health
- mental health
- transcription factor
- big data
- systematic review
- primary care
- rheumatoid arthritis
- emergency department
- social media
- randomized controlled trial
- machine learning
- risk assessment
- meta analyses
- human health
- quantum dots
- fluorescent probe