21st-Century Oncology Drug Safety via New-Age Regulatory Standards and Practices.
Authors of this article are:
Pitts PJ, Le Louet H, Katz G.
A summary of the article is shown below:
There is no such thing as a drug that is 100% safe or effective. Determining whether or not a new oncology treatment (or an additional indication for an existing medicine) should be approved by a regulatory licensing authority is, ultimately, as much regulatory science as public health art and nuance. There are many dynamic shifts in regulatory science (expedited review pathways, biomarker validation, use of real-world evidence, expanded off-label usage, etc) interpreted and expressed within the context of 21st-century oncology drug development, and these new tools and the learnings gleaned from them are helping to advance patient care. They are also helping us to carefully reconsider the levels of uncertainty we find in benefit-risk data and clinical calculations. New-Age Pharmacovigilance can be a tool in product development, regulatory review, postmarketing surveillance and enhanced clinical outcomes.
Check out the article’s website on Pubmed for more information:
This article is a good source of information and a good way to become familiar with topics such as:
adaptive clinical trials;expedited reviews;pharmacoepidemiology;pharmacovigilance;real-world evidence
Categories: Science News