I admire the fight for clinical trial abundance, I truly do, but the longer I think about it the more convinced I am that making nips and tucks to federal law and FDA guidance is the wrong way to go about it.
I have been involved in clinical trials for more than a decade and have seen it through the eyes of an investigator, sponsor and IRB member directly, and owing to a few friendships with ex-FDA employees, from the eyes of regulators as well. The common thread between all cases of delay and all frustrated attempts to speed things up were not laws and regulations but humans. The blankfaces and boxcheckers. Those IRB members who prefer the list of possible toxicities in a consent form in table form as opposed to a list, or a list as opposed to a table, and with percentages of expected occurrences instead of qualitative statements of possibility, but can you please explain what does percentages mean in qualitative terms, and is it “toxicity” or “adverse event”, and you should list only true toxicities not hypotheticals, except when we require you to add each potential adverse event — sorry, toxicity — whether it happened in this or other trials or not, and for each round of these changes there is another 3-week turn of the IRB roulette during which a different person may view the edits and give their own two cents — leave their own fingerprint.
And that is only the IRB! Their are personal imprints to be made at every level of clinical trial desing and implementation, between different departments of the Sponsor, “key opinion leaders" Or “KOLs”. The whole KOL ecosystem is worth writing about at length, just not today. sitting on advisory boards, administrators and worriers-in-chief at clinical trial sites, and even, rarely, clinical trial investigators themselves although in the US at least they are the ones least involved in clinical trials. More often than note, the way to leave your fingerprint is by citing a rule or a law or precedent from the FDA or the IRB or some other state-level regulatory agency whether or not said rule, law and/or precendent apply.
To be clear: most people in the clinical trial ecosystem are not like this. But much like airport noise complaints, in which one household accounted for almost 80% of all complaints, it only takes a handful of people to gum up the works and make it appar like the whole system has conspired against smooth trial execution.
So ho do we achieve abundance? Cutting down on the laws that govern trials is an option, and would certainly reduce the degrees of freedom at which blankfaces and boxcheckers operate. But America is a country of min-maxers and I can easily see things going sour with drive-by trials and phase 1 clinics being run out of a storage unit in South Florida. Which operate even now, so just you wait for the walls to come down and the minmaxing trial beast to be unleashed. Chesterton’s fence and all that.
Could we not reduce the number of gummer-uppers in the chain instead? There are plenty of trials that are quick to start, quick to execute, and not even all that costly, largely due to people being reasonable. Can we inject more reasonable people into the ecosystem, if we can’t inject more reason into people who are already there?
This thought brought me to Delaware, the second smallest state of the USA that has 60% of Fortune 500 companies incorporated there owing to the convenience, flexibility and predictability of its corporate law system. To my layperson’s eyes it seems, from the example of Delaware, that its not the law itself that makes the difference but rather who implements it and how — which was on spectacular display earlier this week.
Convenience, flexibility, predictability.
Now clearly the Delaware of clinical trials can’t be Delaware — it is far too small and wouldn’t have enough trial candidates. But California, Texas, Florida and New York could all vie for the spot, each having a population similar to Australia, the phase 1/2 promised land. Texas was the first to make some waves, tiny and of an uncertain direction, but in the ballpark of what would be needed. The only changes that federal law needs are those that would allow the states to compete among themselves in being clinical trial champions.
If that last image made you think of China and its competing provinces, it is for a good reason: the Chinese have been eating everybody’s lunch for the past few years, in large part because of the vicious internal competition elaborated on elsewhere. There are other lessons there, for some other time.