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Too Complex, Too Costly: Are CROs Draining Clinical Trials?
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Released: October 01, 2024

Expiration: September 30, 2025

John Marshall
John Marshall, MD
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Complexity Overload: CROs and the Rising Cost of Clinical Research

[00:00:05]

John Marshall, MD:

Let's shift gears now to our middlemen series. And the next area we really want to focus on, as I've mentioned, is clinical research organizations. And I have two outstanding folks that we're going to interview to talk about this sort of from all angles, but I want to just set the stage with a very brief history of what all happened. I've been around since before CROs were really much of a thing. They only came into play, in the 1980s. And this was because of the worries that clinical trials were getting to be more common and that we needed to have our data cleaner. The FDA was, in fact, tightening up in some way. The way packages would be submitted to them for approval or not. It wasn't just the trial, yes or no, on a curve. You needed to have all of the data in there together. It needed to be highly qualified data, good quality data.

[00:01:06] You know, I always joke that even the National Cancer Institute, you would think they could handle this. They went out and got a CRO, and they partner with Theradex. And they have for many years. What the issue here is, is that the sponsor, somebody who wants to do the trial, needs to get access to that patient who fits their trial. And traditionally, they just needed us, the clinician, who did clinical research, to identify and enroll that patient on the clinical trial. But, we apparently didn't do a good enough job of maybe managing the data, is really where we got in trouble. We're good at finding the patient, not good at managing the data, maybe, or at least to the quality that we need. And that's what CRO's who now get inserted into all of this will do. They came in as the savior for all of this problem. They said, don’t worry, sponsor, we'll find you the best sites. We'll make sure their data is the best. We'll train them and we'll make sure your package is great, and we will, by the way, add a whole lot of money to the overall cost of the clinical trial. Some say as high as one third of the per patient costs goes to the CRO to manage this.

[00:02:16] These are for-profit companies. We need to remember this. These trials are going through the roof in terms of numbers of trials, complexity of trials, so that as a result of this too, the number, the value of per patient accrual. So, what it costs to put a patient on study is going through the roof and it's a competitive marketplace.

[00:02:35] Back in the day when I was young, you know, you could put a patient on a study for, I don't know, 2,500 bucks a, a head. And that was enough to do all the data analysis. Of course, that was old money. New money, you need to add at least one zero, maybe two zeros per patient. and so, the cost of one patient on a clinical trial has gone through the roof in large part due to this additional administrative oversight. So, we get analyzed. We get trained. We have to hire up all the people. They hire up all the people to cross check one another. That actually, made it incredibly expensive so that, it's actually made it not very much fun.

[00:03:16] So, I was the associate director for clinical research here at Georgetown for a long, long time. And I just got to the point where this got to be crazy. Even I as a clinician didn't like it very much. I was signing forms that said I had to sign a form. Just the burden of documentation was so much. Today, I saw 4 patients on clinical trials, and I was noting that with each 1 of those, it cost me about 10 extra minutes of documentation to make sure that I had all the data that was needed for the audit and, our own people to enter the data, et cetera. And remember, back when we were talking about EMRs last week, they're not really built for clinical research, are they? So, we have to hand do and then hand enter a lot of the data from clinical trials into some other EMR for the CRO to give to the sponsor.

[00:04:09] So very, very inefficient. So, what do we do? Like everything else? We offshore it. One of the consequences of CROs has been that the U. S. market can't handle this. And so, lots of clinical research is done in parts of the world where they're dying to get on clinical trials, right? We're a rich country. We have access to everything. Lots of places don't. So, if they do trials, they actually get that investment there locally and their patients can have access to newer therapies. So, we enjoy FDA approvals on the backs of studies done in other countries where the price differential is better for those sponsoring and managing the clinical trial. We need to think about that as we move on to the next FDA approval. A lot of the work was done by other patients who probably in the end won't have access to the drug that we will have access to.

[00:05:07] And then the last piece of this is that. You know, the specificness of a patient to enroll into a clinical trial. We already have the precision medicine piece, so they have to have the right gene test, but they also have to have a very good, what we call, performance status. Their labs have to be perfect, so much so that the patients who are on trials don't actually represent the patients that we will end up using the drug on. So, to get these pristine results, we have to test pristine patients, then apply the drug to the less pristine. And so, we have a disconnect there in all of this.

[00:05:49] And then the last part of this, of course, is, is the patient interested in participating? some are, yep, we know that, but we are still well below where we need to be as a nation, as a world, in clinical research. Because let's face it, we haven't figured out cancer. We could argue that almost every patient should be on a clinical trial. And yet patients are not really incentivized to participate in clinical trials. And I think actually, there needs to be some change in that space too, but not from my perspective, an old grumpy guy whose kind of a little burned out on the clinical research world. Let's talk to some experts.

[00:06:25] ​

This transcript has been edited for clarity.