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Posted On: 07/11/2019 10:24:38 AM
Post# of 154852
Okay found the big study.
BIO Releases Largest Study Ever on Clinical Development Success Rates
Today, the Biotechnology Innovation Organization (BIO) released the largest study ever of clinical development success rates. The study, conducted in partnership with Amplion and Biomedtracker, recorded and analyzed 9,985 clinical and regulatory phase transitions, across 1,103 companies. Using clinical trial data from the past decade, “Clinical Development Success Rates 2006-2015” compares groups of diseases, drug modalities and other attributes to generate the most comprehensive analysis, to date, of biopharmaceutical R&D success.
https://www.bio.org/sites/default/files/Clini...202016.pdf
They didn't have unmet need, they did have rare, which might be relatable.
The BLA to approval was slightly higher, I was expecting more. But phase 1 to approval much higher, so approval higher on earlier phases instead of BLA to approval.
Other items.
By category:
Approved on first review ~70%.
Importance of biomarkers
Monoclonal Antibodies have higher success rate
BIO Releases Largest Study Ever on Clinical Development Success Rates
Today, the Biotechnology Innovation Organization (BIO) released the largest study ever of clinical development success rates. The study, conducted in partnership with Amplion and Biomedtracker, recorded and analyzed 9,985 clinical and regulatory phase transitions, across 1,103 companies. Using clinical trial data from the past decade, “Clinical Development Success Rates 2006-2015” compares groups of diseases, drug modalities and other attributes to generate the most comprehensive analysis, to date, of biopharmaceutical R&D success.
https://www.bio.org/sites/default/files/Clini...202016.pdf
They didn't have unmet need, they did have rare, which might be relatable.
The BLA to approval was slightly higher, I was expecting more. But phase 1 to approval much higher, so approval higher on earlier phases instead of BLA to approval.
Other items.
By category:
Approved on first review ~70%.
Importance of biomarkers
Monoclonal Antibodies have higher success rate
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