Estimation of clinical trial success rates and related parameters
in response to
by
posted on
Jan 27, 2019 09:54PM
Numbers get tossed around a lot...when I was at the B&B bio investor conference in May...the opening presentation included some of the numbers of the % of drugs that move from pre-clinical to clinical, and then from phase 1 to phase II, from phase II to phase III and then onto approval.
Statistics get tossed around a lot.....and I recall a famous quip by David Letterman where he said something like, "78.3% of all statistics are made up on the spot". Or to modify one of my late great father's favourite bromides: "There are 3 kinds of lies. Lies, damn lies and statistics". In the original the third lie was accounting.
I've looked at this before but the language is so clinical and filled with mintutae that I find it hard to read and remain concious. But CarpeDiem's post got me looking again, here's a yawn inspiring but decent looking article on the subject:
https://academic.oup.com/biostatistics/advance-article/doi/10.1093/biostatistics/kxx069/4817524
What I'm seeing is that based on analysis of over 15K compounds, from over 5,700 companies over a 16 year time frame (up to 2015) that success rates for drugs across all indications ranges from about 50% to 70%....Specifcally for Cardiovascular disease, if I'm reading Table 2 correctly its indicating a success rate of 62.2% based on 964 trials, or "paths".
What I'm reading in this article suggests a far higher approval rate than CP's 30-40%. Of course even if I'm reading this correctly, and I did not dive deeply into the article but rather gleaned it looking for what I figured to be information pertinent to Apabetalone....but if I am am reading it right it still means that over one third of cardiovascular drugs still fail to get approval even after phase III trials.
I'd love to read Bear's or anyone else's thoughts of course.