Clinical Trials Are 'Too Damn Complicated'

John Marshall, from Medscape. I'm blue right now. The weather is terrible here in Washington, DC. I think it's going to rain for the next 4 years, quite honestly.

I like my job, but for the first time in my career, over the past year or so, I really do not like doing clinical research. Now, do not get me wrong. I love putting patients on clinical trials. I love having new things to offer and refining what we are doing, so that we can move the bar. I love that. It's what I was born to do. I really do like it.

Clinical Trials Are 'Too Damn Complicated'

Nowadays, clinical trials are too damn complicated: starting one, getting the administration going, doing the training, filling out the forms, signing the electronic stuff, clinical research organization (CRO) meetings day in and day out, 20 different emails every day for every side effect that has ever happened anywhere on the planet. The administrative duties of clinical research have made it no fun anymore. It really has stopped being very productive. It's taking us forever to start a study.

It's costing us a lot of money to staff them, which is just passed on to pharmaceutical companies, who then have to charge more and more for their drugs.

The administrative duties of clinical research have made it no fun anymore. It really has stopped being very productive.

We have to lower the cost of clinical research. We have to. We have to figure out how to do this.

One piece of this seems to be the whole CRO management. I'm no world's expert; I promise you. I do what I'm told, and I try to follow the law—what the US Food and Drug Administration expects, what is good clinical practice, et cetera. But it seems to me that it's gotten out of hand. There is just too much being done. We are expected to do more and provide more detail. We are not utilizing our electronic medical records (EMRs) adequately. I think this is one of the gripes of Grandpa Joe Biden, bless his soul, who is no longer in that spot. We would like to have him here running things.

We have to figure this out. I heard from one of the major pharmaceutical executives that something like one third of all clinical research expense is going to these outsourced CROs. They are incredibly valuable groups of people. They make clinical research possible in some way. But we have to tamp it down. We have to simplify.

Simplifying Clinical Research and Reducing Cost

I'm involved in a few projects that are trying to do that. Could we get to some simplified common data elements that are being collected in every one of our EMRs? Then, with these clinical elements, could we look at outcomes, benefit, and toxicity in a much simpler way than we are currently doing? Is the regulatory world out there ready for that? My feeling is that they are. They want to know safety and efficacy. I think we can do that without all of that added cost and expense.

With one of our collaborations, a group called the Caris Centers of Excellence, we are looking at an endpoint called "time to next treatment" (or "TNT," as we call it). When I click "stop giving oxaliplatin" and "start giving irinotecan" in a colon cancer patient, that is being very accurately collected in my EMR. Nobody has to do anything but me. I'm providing the data on it. I've moved from front-line to second-line. Can we use simple measures such as that—when we change from one kind of therapy to another—to measure outcome and benefit from a given treatment?

We are really trying to use TNT as a simplified way, because as soon as I want to measure progression-free survival or something like that, all of a sudden it costs a whole lot of money. Somebody has to show the scans, so I have to do a lot more scans and, all of a sudden, I've ramped up my costs.

'Make Clinical Research Fun Again'

Collectively, as clinical researchers, we need to push back a little bit when they ask us to retrain for the third time on something where all we have to do is click a button with our passcode to sign off. That will save us time and money. We need to push back on all of this data collection, re-collection, and queries and ask, "Is it really necessary to do all of that work and spend all of that money for a clinical trial result?" We need to innovate and think forward for other easy ways [to do research], such as measuring outcome with data we already have in our systems. I think if we can do this smartly, we will lower costs, speed accrual, and—what I really hope for—make clinical research fun for me again.

John Marshall, from Medscape.

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