Quality of evidence considered by Health Canada in granting full market authorisation to new drugs with a conditional approval: a retrospective cohort study.
Joel R LexchinPublished in: BMJ open (2018)
Postmarket studies required by Health Canada had more rigorous methodology than those required by either the Food and Drug Administration or the European Medicines Agency. There were still deficiencies in these studies. The absence of blinding in the majority of RCTs may introduce bias in their results. The use of surrogate outcomes especially in oncology trials means that improvements in survival are not available. The relatively young age of patients, even for products for cancer, means that predicting how the elderly will respond is often unknown. The almost universal finding that men outnumbered women may make it hard to differentiate responses by sex. These results raise potential concerns about the quality of evidence that Health Canada accepts.
Keyphrases
- drug administration
- public health
- healthcare
- mental health
- end stage renal disease
- human health
- middle aged
- chronic kidney disease
- newly diagnosed
- prognostic factors
- type diabetes
- squamous cell carcinoma
- health insurance
- young adults
- papillary thyroid
- case control
- peritoneal dialysis
- polycystic ovary syndrome
- adipose tissue
- metabolic syndrome
- climate change
- childhood cancer
- skeletal muscle
- pregnant women