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Dear all,
Can anybody direct me to a publication, where the average number of
clinical trials (phase 1 through 3) for a new drug candidate is
discussed? I have heard of 65 studies per drug from first in man to
phase 3 but cannot confirm it.
Best regards,
Toufigh
--
Toufigh Gordi, PhD
Independent PK/PD and Clinical Pharmacology Consultant
www.tgordi.com
E-mail: tg.-at-.tgordi.com
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Toufigh:
I have reviewed several years of NDA information posted at drugs.-a-.FDA. Not all clinical studies will
necessarily be listed in this info (some companies most notably foreign companies may not submit all
clinical studies to the FDA) and the number of studies is going to vary widely. First in class are
going to have more as are drugs with in vitro or structural data that is suggestive of drug
interactions. All significant proportion of more recently approved drugs have been for the
indication of cancer or orphan diseases which is going to skew the number down quite a bit.
Overall, 65 seems like a high number.
Carol Collins
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Toufigh
It's a good question and the people who ought to have the most recent data are the Pharmaceutical
Research and Manufacturers of America who have a website with a contact link at
http://www.phrma.org/innovation/clinical-trials
I would expect them to say it varies so much that a mean means little, but in any case I'd be
interested to know the answer if you get one.
Good luck
Andrew
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Dear Toufigh - 65 studies per submission is perhaps an outlier, certainly not the norm. Based on my
experience with a vast number of NDAs and BLAs:
1. Clinical pharmacology studies: an average of 15-20 studies per submission.
2. Registration trials: an average of 2 per submission (this is the part that is tricky; the number
of trials are approx. proportional to the number of indications sought).
Joga Gobburu
University of Maryland
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