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Wednesday, November 14, 2007

Ah yes the data.

Below I note that the best available dataset, suggests that the NIH alone is running more phase III clinical trials than is "industry".

I learned this reading Derek Lowe's blog

Lowe quote "Encephalon" (and links to a dead URL)

It is a myth, and I would argue a more prevalent one than the myth that Big Pharma simply leaches off government-funded research, that the NIH does little to bring scientific breakthroughs to the bedside (once they have made them at the bench). . .Using arguably one of the best (databases) we've got (the NIH's**) we get the following figures: of the 15,466 trials currently in the database, 8008 are registered as sponsored by NIH, 380 by 'other federal agency', 4656 by 'University/Organization', and 2422 by Industry. While I am suspicious that the designation 'university/organization' is not wholly accurate, and may represent funding from diverse sources, and while the clinical trials in the registry are by no stretch of the imagination only pharmaceutical studies, the 8388 recent trials sponsored by Federal agencies are no negligeable matter. I think Dr. Lowe will agree."

A reader e-mails in a breakdown by phase. Phase I trials are uncontrolled trials testing for toxicity and pharmokinetics and stuff. Phase II trials are small double blind controlled studies, Phase III trials are large and may be followed by FDA approval if the results are good.

Regarding the 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.

Derek Lowe asserts that many industry trials are not in the database.

I agree that NIH has a real role in clinical trials, but I don't think it's a large as these figures would make you think., since it's an NIH initiative, is sure to include everything with NIH funding, but there are many industry studies that have never shown up there. (And I share the scepticism about the "University" designation.) When the Grand Clinical Trial Registry finally gets going, in whatever form it takes, we can get a better idea of what's going on.

Lowe can be skeptical of the 'university/organization' category, but he should not ignore it completely in a blog archive on industry vs academia. I don't understand his distinction between and the "Grand Clinical Trial Registry ". is a mandatory clinical trial registry. I don't see how it can get any grander. I guess that Lowe criticized the data set on a web page without clicking the links explaining what it is.

He presents 0 evidence and 0 examples.

He works for Merk, so I am surprised that he claims that US pharmaceutical companies often flaut the law. Registration is obligatory

F. Which trials are provided to the public through the Clinical Trials Data Bank?

Section 113 of the Modernization [1997] Act requires sponsors to submit information about clinical trials of experimental treatments for serious diseases and conditions when conducted under the IND regulations. 42 U.S.C. 282(j)(3)(A). Such information can be submitted at any time with the consent of the protocol sponsor, and must be submitted within 21 days after a trial to test effectiveness begins. In addition, section 113 of the Modernization Act states that information on all treatment IND protocols and all Group C protocols must be included in the Clinical
Trials Data Bank

Group C protocols are specific to drugs which have shown progress against specific tumour types.

An IND must be granted by the FDA before phase I (that means before the drug is given to people). INDs are required for new uses of old drugs if, among other things, the study is intended to "support a significant change in the advertising for the product"

If the pharmaceutical industry is conducting clinical trials without informing the FDA, they are either breaking the law or spending money in a way which can't possibly help their shareholders.

I don't think that big pharma is a collection of saints, but I am sure they are very very careful not to piss off the FDA, so I find the claim that there are many recent clinical trials not included in absolutely incredible.

For trials before 1997, the data base would have to be filled in by someone at the *.gov using FDA data on INDs. I don't see why this is more obscure than NIH data on funding. The FDA data are, by law, comprehensive. It would be insane not to start the register with them.

So it seems that industry is doing well less than half of phase III trials.

I am shocked. I have a fairly high opinion of big pharma R&D but Lowe is convincing me that I may have grossly overestimated industry's contribution.

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