Clinical research study cost breakdown?
December 6, 2021 5:26 PM Subscribe
I'm curious where I can find resources explaining the costs that go into running clinical medical research studies.
I read a reasonable number of clinical research papers. I'm curious what the costs associated with theses studies are. I'm aware that this must vary dramatically by study, so I'm interested in resources that talk about the breakdowns of costs of various studies (costs involved in procuring any drugs/devices under study, recruiting volunteers, paying the people running the study, paying the people involved in administering the treatments, etc).
I figure that grant proposals must have breakdowns like this, but it seems like grant proposals are generally not publicly shared (this (sadly login-walled) article talks about using FOIA to get access to federal grant proposals, and how this often frustrates the people writing the grants, since the field is seen as so competitive) — are there any scientific communities where people share the details of their grant proposals?
I'm also interested in resources that talk about costs holistically (for instance, my understanding is that a grant proposal for a specific study usually wouldn't include the stipends for grad students working on the study, since that's paid by their university via a different mechanism — but that labor is a part of the cost of running the study, and I'm interested in seeing it.)
I read a reasonable number of clinical research papers. I'm curious what the costs associated with theses studies are. I'm aware that this must vary dramatically by study, so I'm interested in resources that talk about the breakdowns of costs of various studies (costs involved in procuring any drugs/devices under study, recruiting volunteers, paying the people running the study, paying the people involved in administering the treatments, etc).
I figure that grant proposals must have breakdowns like this, but it seems like grant proposals are generally not publicly shared (this (sadly login-walled) article talks about using FOIA to get access to federal grant proposals, and how this often frustrates the people writing the grants, since the field is seen as so competitive) — are there any scientific communities where people share the details of their grant proposals?
I'm also interested in resources that talk about costs holistically (for instance, my understanding is that a grant proposal for a specific study usually wouldn't include the stipends for grad students working on the study, since that's paid by their university via a different mechanism — but that labor is a part of the cost of running the study, and I'm interested in seeing it.)
I have put together budgets for observational and qualitative research studies. The biggest direct costs are typically salary + benefits (measured in person-months) for the principal investigator and any coinvestigators/coordinators and often subject stipends as well. If there's specific equipment, like lab reagents or something, those are charged to the grant as well. Student stipends or tuition remission generally applies as well.
There's also something called "indirect costs" which are things like electricity for the building, IT support for the computers used in the study, basically anything that can't be divvied up neatly among your study portfolio but without which you can't do your study. This is a negotiated rate, anywhere from 15% for non-profit foundation sponsors to 60+% for pharmaceutical industry sponsors.
For studies that involve drug/device therapy or any lab/imaging, the hospital or clinic charges those to the study rather than insurance. This rate will depend to local factors and is usually similar to the "self-pay" rate at that facility.
For multicenter studies, these budgets are developed at the local level and then approved by the sponsor. As amelioration says, most novel therapy trials are sponsored by the company rather than grants; at least in my field, investigator-initiated work is either super basic science or phase 4 dissemination/implementation science.
Published trials of any sort should have a financial disclosure statement that acknowledges how much (if any) role the sponsor had in analysis and writeup of the study results.
posted by basalganglia at 6:45 PM on December 6, 2021 [5 favorites]
There's also something called "indirect costs" which are things like electricity for the building, IT support for the computers used in the study, basically anything that can't be divvied up neatly among your study portfolio but without which you can't do your study. This is a negotiated rate, anywhere from 15% for non-profit foundation sponsors to 60+% for pharmaceutical industry sponsors.
For studies that involve drug/device therapy or any lab/imaging, the hospital or clinic charges those to the study rather than insurance. This rate will depend to local factors and is usually similar to the "self-pay" rate at that facility.
For multicenter studies, these budgets are developed at the local level and then approved by the sponsor. As amelioration says, most novel therapy trials are sponsored by the company rather than grants; at least in my field, investigator-initiated work is either super basic science or phase 4 dissemination/implementation science.
Published trials of any sort should have a financial disclosure statement that acknowledges how much (if any) role the sponsor had in analysis and writeup of the study results.
posted by basalganglia at 6:45 PM on December 6, 2021 [5 favorites]
Response by poster: Thanks! These are both useful answers.
Not the threadsit too much, but I'm interested in resources that apply to more than just investigational new drugs — studies of NPIs, off-label uses of existing drugs, collecting data on efficacy of existing treatments stratified by different populations, etc.
posted by wesleyac at 6:51 PM on December 6, 2021
Not the threadsit too much, but I'm interested in resources that apply to more than just investigational new drugs — studies of NPIs, off-label uses of existing drugs, collecting data on efficacy of existing treatments stratified by different populations, etc.
posted by wesleyac at 6:51 PM on December 6, 2021
Actual general breakdown of costs in medical adjacent research from our 3 year Build a Better Chicken Grant 2007/8/9. Costs in €
PostGrads 108,000
PG fees 28,000
Technician 90,000
PostDocs 200,000
Salaries (subtotal) 426,000
Consumables 260,000
Equipment 25,500
Travel 22,500
OverHead to host inst 212,000
Total 946,000
So 45% salaries ; 32% Stuff; 22% Overhead to pay for university admin and infrastucture.
Q. Could we find genes in chickens which responded to Campylobacter infection. If we found them they could be "used to breed chickens which were resistant to this major cause of human work-days lost from food poisoning".
A. And the answer was . . . maybe. Which is a rather typical outcome for biomedical research.
posted by BobTheScientist at 6:35 AM on December 7, 2021
PostGrads 108,000
PG fees 28,000
Technician 90,000
PostDocs 200,000
Salaries (subtotal) 426,000
Consumables 260,000
Equipment 25,500
Travel 22,500
OverHead to host inst 212,000
Total 946,000
So 45% salaries ; 32% Stuff; 22% Overhead to pay for university admin and infrastucture.
Q. Could we find genes in chickens which responded to Campylobacter infection. If we found them they could be "used to breed chickens which were resistant to this major cause of human work-days lost from food poisoning".
A. And the answer was . . . maybe. Which is a rather typical outcome for biomedical research.
posted by BobTheScientist at 6:35 AM on December 7, 2021
Educated answers above. As a university based clinical research coordinator (phase 2 and 3 pharma studies involving human subjects) we had always had procedures such as CT scans or MRIs charged to the studies. I found out that there is another breed of clinical trial studies, typically involving oncology studies, where the patients health insurer agrees to share costs with the pharma sponsor. I'm not sure how you'd get that information without insiders sharing the budgets and billing.
I'm not sure what you mean by studies of NPIs because all human subject studies need an NPI or device equivalent assigned to the test article. Studies to expand the labeling of a medication or device approved for another use will be registered as studies by the FDA. Post-marketing research is usually asked (required) of companies after approval, often to collect adverse events (side effects) information that might affect the specifics of approval, which is the "package insert" information found inside every prescription pharmaceutical approved for use.
Also keep in mind that finding information on studies of test articles that "fail" are almost never published so unearthing that information is nearly impossible.
NIH or NCI funded study information may be more accessible to the public, because they are funded with tax dollars. I have had limited experience with this type of study.
posted by citygirl at 10:37 AM on December 7, 2021
I'm not sure what you mean by studies of NPIs because all human subject studies need an NPI or device equivalent assigned to the test article. Studies to expand the labeling of a medication or device approved for another use will be registered as studies by the FDA. Post-marketing research is usually asked (required) of companies after approval, often to collect adverse events (side effects) information that might affect the specifics of approval, which is the "package insert" information found inside every prescription pharmaceutical approved for use.
Also keep in mind that finding information on studies of test articles that "fail" are almost never published so unearthing that information is nearly impossible.
NIH or NCI funded study information may be more accessible to the public, because they are funded with tax dollars. I have had limited experience with this type of study.
posted by citygirl at 10:37 AM on December 7, 2021
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posted by amelioration at 6:34 PM on December 6, 2021 [4 favorites]