JAMA has an article out on who funds and conducts clinical trials. It shouldn’t surprise anyone (although it does seem to be news to some headline writers) that industry funds the great majority of them. What does stand out is that the proportion funded by industry is increasing, although that shouldn’t necessarily be news, either. (If you don’t have access, this article has some of the data).
That change is happening in both the numerator and the denominator. From 2006 to 2014 (the period covered by the article), the number of trials conducted by the NIH went down from 1376 to 1048, a decrease of about 24%. During that same time, though, industry-sponsored trials went up from 4585 to 6550 (up 43%). The first thing to note is that this is definitely not a zero-sum situation – the total number of clinical trials is up about 27%, but all of that rise is due to the biopharma industry. But the concern is that NIH-sponsored trials can (should) be more disinterested. An industry-sponsored trial is more likely to be answering the question “Does our new drug X actually work?”, and that’s certainly a good question to ask. The NIH is better positioned to ask questions like “What seems to work better, Drug X or lifestyle intervention Z?”, or “Which of these generic-drug-based therapeutic regimens works the best?”
The usual gripe about industry trials is that they’re against placebo, and thus harder to compare to each other. But there are a lot of trials against “standard of care” – you don’t run a placebo-controlled trial in diabetes, obviously, and you don’t run one in a cancer indication if there’s any sort of therapy at all. But when you have several different mechanistic choices in a given disease area (diabetes and hypertension are two notable examples), then good head-to-head comparisons may be harder to find, and that’s where NIH trials can be very useful as well.
So why is the NIH running fewer trials? Well, their budget has been drifting downward over that period. The NIH had some of its biggest funding increases ever under the first term of the Bush-43 administration, peaking in 2003 (a fact that you could probably win some bar bets with, if you’re in the right sort of bar). The only comparable period was the late 1950s and early 1960s, in percentage terms. The funding wandered down after that, but was still far higher by 2008 than it had been in 2000 (under the Obama administration, it’s been flat or down every year (see figure 2 in this link). So starting in 2006 would mean that you might well be catching the agency at or near its all-time clinical trial peak – that’s enough time for the peak funding years to have worked their way into the clinic. It’s important to not look back at 2003-2006 as a period representative of how things had always been, because that was an era when the agency had just gone through its biggest expansion ever.
I should note, as an aside, that the Figure 2 that I linked to has a deeply stupid trend line attached to it, labeled “pre-austerity growth trend”. That steeply ascending line should be called “growth trend if the historic Bush-era NIH budget increases had continued every single year thereafter”. If you pick the 1980-2000 budget line, though, and extrapolate out, you actually get to where the NIH budget is today, although I’m sure that this would be a deeply unpopular line of argument at the agency and with those that it funds. Looked at this way, the Bush-era increase has turned out to be an outlier – the second Bush term and both of Obama’s have, in effect, let the NIH budget settle back to where it would have been by now had that rise never taken place. (The problem, though, is that the agency’s funding does not look set to begin rising again at even its former rate, much less the rocket launch of 2000-2003).
What would be interesting would be a chart of the total number of NIH-sponsored clinical trials going back to the 1990s, but I’ve been unable to find those numbers so far. My guess is that these also experienced a big jump, a couple of years delayed from the budget increases, and have been trending downward ever since (the latter part of which fits the JAMA numbers). Keep in mind, though, that clinical trials themselves are (and have always been) a small part of the agency’s activities.
So overall, I’d guess that the NIH’s clinical presence has probably tracked its budget pretty closely, whereas industry is definitely spending more. We should be glad about the number of clinical trials going on, absent more information about just how well-thought-out all of them are.