[Ip-health] Costs of Clinical trials: DiMasi I and DiMasi II compared

[James Love]

Given the data we look at, the most eye popping part of the recent
DiMasi study concerns the estimates of the costs of clinical trials,
which are *way* up over previous numbers, which themselves were
considered high.  Given the fact that some products like Glivec, are
approved on the basis of small trials (about 1,000 patients), it is
difficult to see how one can estimate the *average* cost of Phase III
trials at $86.3 million, for example, or how the median cost of Phase I
trials increased from $1.5 million to $13.9 million, or how the total
for Phase I, II and III rose from $28.6 to $125. Note also that the TB
Alliance estimated: "A full programme of clinical development (Phase I
through Phase III trials) for a new anti-TB drug is estimated to cost
about $26.6 million in a country with an established economy. Comparable
studies conducted in a country with a developing economy are estimated
to cost approximately $9.9 million."

Here are the raw (not adjusted for capital costs or risks) DiMasi I and
DiMasi II data for clinical trials compared.

Average out of pocket cost for clinical trials by Phase, in 2000 dollars

Phase I
	DiMasi I
	Mean   $ 3.2
	Median $ 1.5

	DiMasi II
	Mean	$15.2
	Media   $13.9
Phase II
	DiMasi I
	Mean   $  6
	Median $  3.3

	DiMasi II
	Mean	 $   23.5
	Median   $   17

Phase II
	DiMasi I
	Mean   $  19.4
	Median $  12

	DiMasi II
	Mean	 $   86.3
	Median   $   62


Total, Phase I, II and III
	DiMasi I
	Mean  28.6
	Median  16.7

	DiMasi II
	Mean 125
	Median 92.9

--
James Love, Director, Consumer Project on Technology
http://www.cptech.org, mailto:james.love@cptech.org
tel. +1.202.387.8030, mobile +1.202.361.3040