Clinical trials in private practice?

[Rheumination1]

Hello, would any of you have any info on pursuing clinical trials in a private practice setting? Was briefly offered today and will be discussing more in detail with the company at a later date, but I really am clueless in terms of how it's set up and what the reimbursements are like. Any insight would be great. As a side note, I'm part of a rheumatology group. Myself and the other partners are still pending a decision whether want to take part in it or not.


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[gutonc]

Oh, man....

Clinical trials are a huge deal, and can be lucrative, depending on the setting.

The first thing to ask is if you have the support staff to manage this. From the MD side, trials just look like any other treatment. But there is a metric crapton of administrative and regulatory stuff that goes along with it. If you don't have dedicated staff for that, or the sponsor is unwilling to provide that support, then you should forget it.

I'm a huge supporter of clinical trials, and am currently the PI on 6 of them (2 of which are studies I wrote and got funding for by myself) but they are a total PITA on the admin side of things, and if you (or somebody else in your group) aren't willing to put up with the drama, then you should avoid it.

On the upside, they can be a great patient recruitment tool. I have a study that is almost (maybe, soon, someday, c'mon man) about to open and I've already seen 4 patients this month who want in and are willing to forego treatment (for metastatic pancreatic cancer) in the hopes that they'll be able to be part of the study.

 

[Rheumination1]

Thanks for the info. On a realistic level, how lucrative is it? Do you get paid per patient enrolled in trial or just a set amount? And are the patients who are recruited in the "there's no other hope" category or are they generally in better health with a good prognosis? I guess what I'm asking is what is the patients incentive to be enrolled in the trial?


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[gutonc]

Thanks for the info. On a realistic level, how lucrative is it? Do you get paid per patient enrolled in trial or just a set amount? And are the patients who are recruited in the "there's no other hope" category or are they generally in better health with a good prognosis? I guess what I'm asking is what is the patients incentive to be enrolled in the trial?

In general, you get paid per patient. But you need to look at the budget for the particular trial.

Recruited patients will depend on the study. There are first-line, 2nd-line and Nth-line studies.

 

[Rheumination1]

Aside from the headache, downsides??


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[gutonc]

Aside from the headache, downsides??

It's a lot of work, especially if you're the local PI. The payment you get from the sponsor may or may not translate into more money in your pocket. In PP, I suspect it will actually cost you money.

 

[IM2GI]

It's a lot of work, especially if you're the local PI. The payment you get from the sponsor may or may not translate into more money in your pocket. In PP, I suspect it will actually cost you money.

If you have the infrastructure in place you can make a lot of money doing clinical trials in practice.

 

[Rheumination1]

If you have the infrastructure in place you can make a lot of money doing clinical trials in practice.

Would you say it is a bad idea for a fresh fellow in private practice?


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[IM2GI]

Would you say it is a bad idea for a fresh fellow in private practice?


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Starting a program from scratch? seems like a bad idea.

 

[GastriqueGraffin]

As a chief resident I've thinking of trying to start clinical trials in the outpatient clinics of my IM residency. We have a large patient population and I feel like it's an untapped potential source of revenue for the program and research involvement opportunities for faculty and residents. Any thoughts on whether this is something worth pursuing and how I would go about doing it?

 

[IM2GI]

As a chief resident I've thinking of trying to start clinical trials in the outpatient clinics of my IM residency. We have a large patient population and I feel like it's an untapped potential source of revenue for the program and research involvement opportunities for faculty and residents. Any thoughts on whether this is something worth pursuing and how I would go about doing it?

The way to make money with clinical trials is through pharma. This requires infrastructure, research staff, a PI, etc. This is not the kind of thing a chief resident can just start up.

 

[gutonc]

The way to make money with clinical trials is through pharma. This requires infrastructure, research staff, a PI, etc. This is not the kind of thing a chief resident can just start up.

Exactly.

I know everyone thinks pharma is the devil (and they largely are), but they're the only ones out there providing funding for trials.

I'm currently the PI on 4 trials. 2 industry sponsored, 2 are IITs that I wrote. One of the IITs is diagnostic only and is funded by a biotech company. The only thing it involves on the clinical side is a blood draw at the time of diagnosis. The other is a study of high-dose Vitamin D supplementation as an adjunct to chemotherapy in colon cancer. It is funded by a foundation grant that covers the drug, quarterly Vitamin D levels for 1 year and about $5K worth of research staff time.

The 2 industry sponsored trials provide free drug, pay for all clinic visits (but not labs or imaging which are standard of care) and pay about $8-10K/patient we enroll. This covers the salary/benefits/indirect costs such as office space and computers for the half dozen research coordinators/assistants that are required to make it all work. And when I say that money covers those costs, what I mean is that, over the 2 trials that I have, as well as the 15-20 other trials that the other docs in my group have, we can pay those people.

Bottom line, any kind of interventional/drug trial, is going to require industry money. And the timeline for getting a trial going is usually on the order of 6-18 months. Not the sort of thing an IM chief is going to be able to do.

 

[GastriqueGraffin]

Thank you both for your honesty. I wasn't planning on doing it alone nor would I plan to be the one to complete everything in the period of time that I'm a chief resident. I was just thinking of getting the ball rolling and setting out a plan with the support of the program to see what the necessary steps would be.

 

[IM2GI]

Exactly.

I know everyone thinks pharma is the devil (and they largely are), but they're the only ones out there providing funding for trials.

I'm currently the PI on 4 trials. 2 industry sponsored, 2 are IITs that I wrote. One of the IITs is diagnostic only and is funded by a biotech company. The only thing it involves on the clinical side is a blood draw at the time of diagnosis. The other is a study of high-dose Vitamin D supplementation as an adjunct to chemotherapy in colon cancer. It is funded by a foundation grant that covers the drug, quarterly Vitamin D levels for 1 year and about $5K worth of research staff time.

The 2 industry sponsored trials provide free drug, pay for all clinic visits (but not labs or imaging which are standard of care) and pay about $8-10K/patient we enroll. This covers the salary/benefits/indirect costs such as office space and computers for the half dozen research coordinators/assistants that are required to make it all work. And when I say that money covers those costs, what I mean is that, over the 2 trials that I have, as well as the 15-20 other trials that the other docs in my group have, we can pay those people.

Bottom line, any kind of interventional/drug trial, is going to require industry money. And the timeline for getting a trial going is usually on the order of 6-18 months. Not the sort of thing an IM chief is going to be able to do.

Let me know how the vitamin D works out for you. I feel like vitamin D went from being the next big thing to a nothing burger relatively fast.

 

[gutonc]

Let me know how the vitamin D works out for you. I feel like vitamin D went from being the next big thing to a nothing burger relatively fast.

It's a bit of both. I suspect that my study will be negative. Or, at the very least, not positive. But I'll get a bunch of posters and at least one crappy publication out of it.

 

[IM2GI]

It's a bit of both. I suspect that my study will be negative. Or, at the very least, not positive. But I'll get a bunch of posters and at least one crappy publication out of it.

Academia in a nutshell.

 

[IM2GI]

It's a bit of both. I suspect that my study will be negative. Or, at the very least, not positive. But I'll get a bunch of posters and at least one crappy publication out of it.

I just ordered a pair of Keens, Merrells and Mephistos based on some old thread you posted in. Don't let me down.

 

[gutonc]

I just ordered a pair of Keens, Merrells and Mephistos based on some old thread you posted in. Don't let me down.

At least one of them will probably work for you.

Funny story...I don't currently own a single pair of any of those.

 

[Raryn]

Let me know how the vitamin D works out for you. I feel like vitamin D went from being the next big thing to a nothing burger relatively fast.

The general vitamin D question is... complicated.

We have extremely clear evidence that low vitamin D is correlated with all kinds of badness, from HTN to cancer to death. Of course, correlation is not causation, and ill people are much more likely to have ****ty diets and not so much exposure to sunlight.

When it comes to whether or not supplementing the levels to bring people to normal improves those outcomes, evidence is mixed... but the meta-analyses are more or less in the camp that it doesn't make too big of a difference. It does seem to help old people fall down less but everything else is +/-.

The VITAL study out of BWH should give us some clear data from a very large trial to help answer the question later this year.

 

[gutonc]

The general vitamin D question is... complicated.

One of the older docs that recently left my group used to get Vitamin D levels on every single patient, every single time that he saw them, regardless of diagnosis.

I picked up a bunch of his patients and quickly trained my MAs that, no, I don't need a Vitamin D level...more or less ever (except on my study, which requires them quarterly, and has "increase in Vitamin D level at 6 and 12 months" as the primary endpoint).

My general advice to patients is that, unless they have ESLD, Vitamin D somewhere in the 2-5K IU/d range is fine/good/harmless/possibly beneficial.