Max’s best catch at Maximum Progress:
[A common critique] that the NIH is funding too many “small trials”. That quote is from FDA officials, but the story has been repeated by many others…I downloaded all the clinical trial data from ClinicalTrials.gov to find out….The average NIH funded trial has 48 participants while the average industry funds the trial. it has 67. A typical NIH-sponsored trial has 288 participants while a typical industry trial has 335 and a typical trial funded by “Others” (mainly universities and affiliated hospitals) has 923 participants.According to the average trial or according to the NIH average it is very small for all the sponsors. This seems to confirm the “senseless little experiments” narrative.
…This narrative is reversed, however, if you divide trials into categories.
Of all the NIH-funded trials are the smallest, but in each category the NIH trials are the largest or second largest. Their lower enrollment ratio is simply because they fund more Phase I trials than Phase III. But NIH Phase I trials have larger sample sizes than industry-sponsored trials on average.
This is an example of Simpson’s Paradox in the wild!
Arguing that the NIH should stop funding unusually small trials is easy but arguing that it should shift from funding Phase I trials that are closer to basic research to later phase trials is less clear cut.
The NIH clinical trial strategy is certainly not perfect and improving it is important. But systematic bias toward “nonsensical small trials” doesn’t really seem to be a significant problem facing the NIH.
Source link