[Ip-health] Size, cost of trials

Jamie Love james.love at keionline.org
Sat Mar 12 05:12:58 PST 2016

​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

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


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

James Love.  Knowledge Ecology International
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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