[Ip-health] Another comparison of DiMasi and PhRMA clinical trial numbers

Els Torreele els.torreele at opensocietyfoundations.org
Tue Mar 15 11:24:12 PDT 2016


An important issue to take into consideration in these calculations/estimations is that, in general, the larger the added therapeutic value, the smaller the trials are that are needed to establish this added value, while very large trials are typically needed when the expected differences are  small (or when non-inferiority is being sought).
It is therefore relevant to look at the size and cost of the trials in connection to the therapeutic value of the new treatment.

Els



-----Original Message-----
From: Ip-health [mailto:ip-health-bounces at lists.keionline.org] On Behalf Of Jamie Love
Sent: Tuesday, March 15, 2016 11:44 AM
To: Joseph DiMasi; Ip-health
Subject: [Ip-health] Another comparison of DiMasi and PhRMA clinical trial numbers

Since both the PhRMA estimates of trial costs per patient and the Tufts/DiMasi study can fairly be called industry estimates, it can be useful to ask yourself how many patients would have been in the trials, if the PhRMA per patient cost estimates are accurate (and why would PhRMA lowball the estimates?)

DiMasi average cost of trials by Phase are:

Phase I 25.3 million
Phase II 58.6 million
Phase III 255.4 million

PhRMA cost per patient by phase estimates are:

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

Phase 1  $ 38500
Phase 2  $ 40000
Phase 3  $ 42000

Using these two data points, the implied number of patients per phase, are as follows:

Phase 1  647 patients
Phase 2  1,465 patients
Phase 3  6,081 patients

I will add that these number of patients are radically different from what you see in FDA medical reviews for the lead indications on new drugs (what most people think the cost of R&D is related to)

I'll let others comment on the PhRMA estimates of the average Phase 1-3 per patient costs, which of course, are PhRMA numbers for the average costs, across all drugs, and in practice vary a lot across different diseases.


Jamie


--
James Love.  Knowledge Ecology International http://www.keionline.org/donate.html
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