A nice shot from Max Maximum progress:
(A common criticism) is that the NIH funds too many “crappy little trials.” This quote comes from a FDA higherbut the story has been repeated by many others…I downloaded all clinical trial data from ClinicalTrials.gov to find out… The median NIH-funded trial has 48 participants, while the median industry-funded trial has 67. The average NIH-funded trial has 288 participants, while the average industrial trial has 335 and the trial funded on average by “Others” (mainly universities and universities). associated hospitals) has 923 participants.
On a median or average basis, NIH trials are the smallest among all funders. This seems to confirm the “crappy little trials” narrative.
…This narrative is reversed, however, when you divide the trials into phases.
Among all trials, those funded by the NIH are the smallest, but within each phase, NIH trials are the largest or second largest. Their low overall enrollment average is simply because they fund more Phase I trials than Phase III. But NIH Phase I trials have a larger sample size on average than industry-funded trials.
This is an example of Simpson’s paradox in nature!
It is easy to argue that the NIH should stop funding unusually small trials, but it is less clear to argue that it should shift from funding Phase I trials closest to basic research to later-stage trials.
The NIH clinical trials strategy is certainly not perfect and could benefit from improvement. But a systematic bias toward “crappy little trials” doesn’t really seem to be a significant problem facing the NIH.
