Foreigners in US trials — how much is out-of-pocket?

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This topic contains 6 replies, has 5 voices, and was last updated by  aschweig 4 years, 4 months ago.

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January 22, 2014 at 7:39 pm  #1261682    


Dear Helpful Doctors,

My mother-in-law will soon exhaust the one trial of significance available to her in her home country. Sadly, she, like many, was randomized to the control arm. I had always thought that a site should not have a preponderance of controls, but I guess my thinking was wrong.

I’d like to bring her here (New York) for a Phase I study so she can be sure to get a newer drug. However, I have been advised by a few trial sites that the study will only pay for the drug — everything else is on us. This seems somewhat odd to me because a personal financial setback could then theoretically get someone booted from a trial if they can no longer afford the scans and blood work — a loss to the trial. (Admittedly, Obamacare mitigates this scenario.)

Is there a feasible path for an effectively uninsured foreigner to participate in a phase I trial within the US without enormous outlays to the hospital each month? (Travel, room, and board are on us — that we fully expect.)

Thanks for your help,


January 22, 2014 at 8:59 pm  #1261686    
Dr West
Dr West

I’m sorry that this question is more one in the realm of social work, and the coverage of potential complications falls within the specifics of the contract for the trial. It’s a question that’s appropriate to ask of the people at the center where the trial is offered. There may well be a social worker there who can help with this issue.

Good luck.

-Dr. West

January 23, 2014 at 11:36 am  #1261698    

Dr. Ben Creelan

Usually the majority of trial-related expenses are handled by the sponsor of the trial. Usually, but not always, the trial sponsor will pay for mandatory scans, especially if the insurance refuses to. However, there are a lot of necessary expenses that can pop up. These expenses are considered ‘standard of care’. For example, if she gets sick from the trial drug and lands in the hospital, you will be stuck. Or if she gets unscheduled bloodwork because she is feeling weak. Practically speaking, it is difficult to treat someone on a clinical trial without an insurance or business plan in place.

The best bet may be to contract with the financial office of the hospital to create a business plan for her. For example, you could pay the first $x dollars of expenses, and after that a flat % of eligible expenses, etc. Sometimes you can appeal to the administrative side of a hospital for charity care as well, depending on the financial hardship of the patient. Hope this helps.

January 24, 2014 at 4:53 am  #1261717    


Thank you both,

Our major concern was paying for costs associated with administration of the trial drugs and trial-mandated diagnostics (e.g., blood work and CT scans).

For each trial, can the amount of out-of-pocket burden vary from site-to-site? (e.g., Yale vs. MSKCC)



January 24, 2014 at 5:32 am  #1261719    
catdander forum moderator
catdander forum moderator

Hi, aschweig, I’ll ask another researcher to chime in.
I hope things smooth out soon,

January 24, 2014 at 6:23 am  #1261720    
Dr Pennell
Dr Pennell

There are a lot of so-called “standard of care” charges that are billed to insurance, or in the case of the uninsured, to the patient. Most visits, labs, and scans fall under this umbrella so the trial sponsor really pays for a minority of the trial costs plus the drug. These costs do vary quite a lot from hospital to hospital but are almost impossible to determine ahead of time, and this lack of transparency is a big part of health care reform so that patients can hopefully make some judgement of cost before choosing a particular provider or hospital. I think consulting with a financial counselor at the hospital makes sense and perhaps they would have some method in place to cover expenses for someone in financial need, but in most places including my hospital a patient without insurance would have to agree to pay these costs before being allowed to be treated (unless it was emergency care of course).

Best of luck, I hope it works out!

Nathan Pennell, MD
Associate Professor, Solid Tumor Oncology
Cleveland Clinic Taussig Cancer Center

Views expressed here represent my opinion, not those of GRACE or Cleveland Clinic Taussig Cancer Center. This information does not constitute medical advice and is intended to supplement and not replace medical information provided by your doctor.

January 24, 2014 at 4:29 pm  #1261726    


Thank you all.

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