[Ip-health] Size, cost of trials

Jamie Love james.love at keionline.org
Sat Mar 12 06:48:41 PST 2016


Mohga, the answer in general is yes, the size of trials does differ by all
sorts of things.

In our analysis of the FDA medical reviews, priority and breakthrough
drugs, and oncology products, all have considerably smaller trials, for
example, for the approvals on the lead indications.

On Sat, Mar 12, 2016 at 9:38 AM, Mohga Kamal-Yanni <mkamalyanni at oxfam.org.uk
> wrote:

> 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
> John Smith Drive, Oxford, OX4 2JY, UK (GMT, CET-1, EDT+5, EST+6)
> UK Mobile   + 44 (0)777 62 55 884
> Follow me @MohgaKamalYanni
>
>
>
> 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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-- 
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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