[Ip-health] Size, cost of trials

Mohga Kamal-Yanni mkamalyanni at Oxfam.org.uk
Sat Mar 12 06:38:05 PST 2016


Does the number of patients and cost of clinical trials differ between 
those for NCE, follow up molecules and FDCs?

Best wishes مع أطيب التمنيات 
________________________________
Mohga -Dictating to the computer so please forgive silly mistakes
Mohga M Kamal-Yanni
Senior health & HIV policy advisor, Oxfam GB
Editor of www.globalhealthcheck.org
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From:   Jamie Love <james.love at keionline.org>
To:     Joseph DiMasi <joseph.dimasi at tufts.edu>, Ip-health 
<ip-health at lists.keionline.org>
Date:   12/03/2016 13:15
Subject:        [Ip-health] Size, cost of trials
Sent by:        "Ip-health" <ip-health-bounces at lists.keionline.org>



​Dear Joe,

I meant to share this with the list.

Now that your paper on drug development costs has been published, and 
gIven
how central are the costs of clinical trials to your analysis, and the 
fact
that in your previous estimate you disclosed to the average number of
patients in the trials (which allowed one to calculate the average cost 
per
patient, and that UACT and others have asked for data on the number of
patients and the cost per patient in the trials, and because these are
numbers that can be used to verify the reasonableness of your your
estimates, can you provide the following information

1.  The average number of patient in the trials, by Phase.
2.   The average cost per patient in the trials, by Phase.

3.  The same information for oncology products, and non-oncology products
4   The same information for drugs approved for Orphan designation, and
non-orphans?

Once we see the numbers for the number of patients in the trials, we can
compare them to the numbers of patients that are reported to the FDA in 
the
medical reviews.

Once we have per patient cost estimates, we can compare them to the
estimated published by PhRMA in a report prepared by Battelle Technology
Partnership Practice Prepared for Pharmaceutical Research and 
Manufacturers
of America (PhRMA), in  March 2015

http://www.phrma.org/sites/default/files/pdf/biopharmaceutical-industry-sponsored-clinical-trials-impact-on-state-economies.pdf


Also, can your sponsors find a way to make the paper public, so it is not
behind a paywall?
​

-- 
James Love.  Knowledge Ecology International
http://www.keionline.org/donate.html
KEI DC tel: +1.202.332.2670, US Mobile: +1.202.361.3040, Geneva Mobile:
+41.76.413.6584, twitter.com/jamie_love
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