How do people enroll in foreign clinical trials?
July 24, 2013 2:55 PM   Subscribe

I want to look into enrolling in an oncology clinical trial that is being conducted in Germany. The lead researcher indicated my being Canadian could be an issue because I would have to live in Germany for the duration of the trial (four months) and because I don't have German health insurance. I know people go to other countries to take part in clinical trials, but how do they do this if they lack health insurance in the country where the trial takes place?

I understand that there is a lot of testing and monitoring with clinical trials (I'm currently in my third phase I/II clinical trial), but wouldn't that be covered by the sponsor of the trial? In this particular case, the trial is being run by a biotech company, not by one of the big pharma companies.

I'm not concerned about the living/travel expenses, and let's say living in Germany for four months wouldn't be an issue.

The number of oncology patients who enroll in clinical trials is low, and I'm sure the number of people who travel to foreign countries for treatment is even lower, so I know it is unlikely I'll get much information on the topic. But if you have any experience with this, even second- or third-hand, I'd love to hear about it.
posted by Felicity Rilke to Health & Fitness (7 answers total) 1 user marked this as a favorite
Best answer: I think the researcher is basically referring to immigration issues. Visas for medical treatment do exist, though I can't find anything on the Germany embassy in Canada's website, only on Germany embassy websites in countries where one needs a visa for the Schengen Zone (for example). But since 4 months is longer than 90 days, you'd need some kind of permission to stay in Germany and that would (I think) entail having German health insurance, since having health insurance is mandatory in Germany.
posted by hoyland at 3:11 PM on July 24, 2013 [1 favorite]

As a side note, Canadians staying in Germany (or the Schengen Zone) for more than 90 days can enter Germany and obtain a residence permit (assuming they qualify, etc) without having to apply in advance while in Canada. Depending on what countries you're familiar with, this may seem rather counterintuitive.
posted by hoyland at 3:14 PM on July 24, 2013

Response by poster: Thanks, that's really helpful, I hadn't considered the visa aspect. This could be worked around by returning home to Canada during one of the periods between testing/treatment, thus breaking the stay into two periods of less than 90 days.
posted by Felicity Rilke at 3:16 PM on July 24, 2013

Unfortunately, it's 90 days within a 6 month period. (Otherwise you could pop over to Britain, never mind all the way back to Canada, and restart the clock.)
posted by hoyland at 3:17 PM on July 24, 2013

Part of the issue may be that, while the testing and monitoring that goes with the trial protocol should be covered by the trial, any treatment you get that represents the usual standard of care for the illness, or for other unrelated health issues may need to be covered by your regular health insurance (let's say antibiotics for an infection related to immunosuppression, or treatment for a broken arm that you get when crossing the street to your medical appointment).
posted by The Elusive Architeuthis at 3:50 PM on July 24, 2013

If money is not an issue, why not get German health insurance? And ask an attorney if there is a special visa you can use to be part of a trial?
posted by 3491again at 4:25 PM on July 24, 2013

Best answer: I work in oncology clinical trials in the US and our foreign patients are wealthy and/or have US health insurance. The Elusive Architeuthis is correct that many (sometimes most) of the procedures in a trial are NOT covered by the study and are considered "standard of care" so are billed to insurance. Only study specific procedures (e.g. special research blood tests) are covered by the study and most labs, doctor visits and even CTs to measure tumor size will be billed to insurance. Without insurance this could get very expensive quickly.
posted by newsomz at 7:15 PM on July 24, 2013

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