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DBL%20Hendrix%20small.png College chemistry, 1983

Derek Lowe The 2002 Model

Dbl%20new%20portrait%20B%26W.png After 10 years of blogging. . .

Derek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other diseases. To contact Derek email him directly: derekb.lowe@gmail.com Twitter: Dereklowe

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In the Pipeline

« One More On Basic Research and the Clinic | Main | No Coming Attractions Here »

September 16, 2004

The NIH in the Clinic

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Posted by Derek

OK, I couldn't resist. Let me reiterate that I completely admire the NIH's commitment to basic research; it's one of the real drivers of science in this country. But they're not a huge factor in clinical trials. Academia does more basic research than pharma; pharma does more clinical work than academia. Here are some statistics from a reader e-mail:

"As a person who was an NIH staffer (funding clinical trials, no less) and is now on the pharma side (mostly spending on manufacturing development; we will spend more on clinical trials as we get bigger), I have seen both sides.

Most of NIH spending is very far from clinical utility. Last time I checked (and it has been a while), more than 90% of NIH funds went to what most people would consider non-clinical research, e.g., studies of animals and cells, etc. (If the NIH was named by its major function, it would probably be called the National Institutes of Molecular Biology ;-) The reason NIH is able to claim that half of its money goes to clinical research' is that any study that involves a human or *human tissues* counts. So a bench study looking at receptors on human renal cells counts as 'clinical research.' The number of studies examining 'whole' humans is in the 5% range.

On the other hand, pharma, as you know, spends a lot of money on research with legal (protecting patent claims), manufacturing (cGMP issues, etc.) and marketing goals that don't necessarily help anyone's health.

Regarding the clinicaltrials.gov numbers, by my reckoning the 8000 NIH studies and the 2400 'industry' studies probably represent about the same investment in *therapeutic* clinical trials. If you break down the NIH trials, about 1800 (22%) are Phase I, 3000 (37%) are Phase II, 1100 (14%) are Phase III, and the rest (2150, 27%) are observational and other. (If you want to check, I did a search within the results for the appropriate phrases and subtracted from the total for the remainder). Figures for industry are 460 (19%) Phase I, 1060 (44%) Phase II, 770 (32%) Phase III, and 133 (5%) other.

In my experience each phase of clinical trials multiplies costs by about 10 times (e.g., Phase I = X; Phase II = 10X, Phase III = 100X), so the clinicaltrials.gov figures imply that the costs of Phase I, II, and III trials funded by industry are over 80% of those funded by NIH (costs are overwhelmingly driven by Phase III trials). And this is despite the close to 100% capture of NIH trials versus the unknown percentage capture of industry trials that you noted in your post."

Comments (1) + TrackBacks (0) | Category: Academia (vs. Industry) | Clinical Trials | Drug Development


COMMENTS

1. threegoofs on September 16, 2004 11:00 AM writes...

Note that many of the expensive NIH trials are post-marketing trials - i.e. "phase IV" and those probably suck up the majority of NIH funding for clinical studies.

These trials are often very long term trials that usually would not be funded by industry because of competitive or patent issues.

I guess I dont understand the comment about NIH funding phase I- phase III trials at all. How would the NIH get a compound under development and owned by a company to fund the trial?

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