In June my colleague Bill Blank published a post called Is Academia Beating The Industry In the Number of New Trials Per Year? It was our 2nd most viewed post of all-time, and we received a number of comments from our readers about the analysis. In summary, the post showed that almost two-thirds of new trials in the last four years have been registered not by industry sponsors as expected, but “other” agencies. This “other” group is almost entirely comprised of academic and medical centers. The following graph puts it into perspective:
The first comment we received on this post, which triggered more comments from readers, was from Richard Jones. He asked:
“Could part of the difference be study size? Industry, of necessity, has to do larger (study subject numbers) studies in order to show meaningful data to the FDA for ND submissions or label expansion.”
This was a great point we wanted to explore further. Maybe the best way to measure clinical trial activity isn’t the number of trials but the number of subjects involved. Look below at the comparison of average number of subjects per trial between Industry and Other funder types, from 2013 to 2016 to date.
To get an accurate sense of the data we removed trials with a phase listed as “N/A”. We also only looked at trials marked as completed.
To answer Richard’s question, yes the industry does enroll more subjects per trial than academic and medical centers. On average industry trials are 40% larger (200 vs 143).
We also wanted to break down the data by phase, and see which part of the clinical development process was contributing to this major difference. As you can see in the chart below, industry trials are, significantly larger in Phase 3 and Phase 4. On average, Industry Phase 3 trials are 72% larger than Other Phase 3 trials, while Industry Phase 4 trials are 267% larger.
The charts above add detail to the average enrollment per trial by funder type. We also want to show you total number of subjects enrolled by funder type. Keep in mind that this is only for trials marked as completed, and does not include Phase N/A studies.
In conclusion, while medical and academic centers have created significantly more new clinical trials in the past 4 years, the industry enrolls on average 40% more subjects per trial. In total, over the last three and a half years, the industry has enrolled 76% more subjects in trials that are today marked as complete.