CRASH2

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Dear Ian,


> - snip -
> Interested to hear about country specific problems other investigators
> had.

though we have been able to participate in CRASH and enroll patients,
there are no centers from Germany participating in CRASH2. That is due
to the fact that we were unable to get insurance for the trial. Terms of
insurance and clinical trials are detailed in an European Union
directive, however, as some countries read the content of the directive
in a way that every possible damage to the patient is covered by the
physician's / hospital's insurance - and thus no further fee is required
- in Germany it is understood that the compulsory insurance has to cover
whatever might happen to a patient enrolled in a clinical trial. That
multiplied the insurance fee in comparison to CRASH by more than 14 times!

Even though every effort was made not only to find an insurance company,
taking the risk for an affordable amount of money we worked hard on the
federal government to reread the rules - in vain. Worse, the offer of a
British insurer had to be rejected because he did not fulfill German
legal requirements!

So hope lies on the new government to change this - but you see everyday
how they struggle with themselves....


Mathias

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