“Ordinary Sense” is Not Always Ordinary in Other Countries -Difficulties in International Clinical Trials -

[Speaker] Toshihiro Matsui:1
1:National Hospital Organization Sagamihara National Hospital, Japan

[Background] We often feel unpleasant when participating in international clinical trials. In some cases it may be acceptable due to cultural differences, but there are also cases where consideration for patients and for other countries is obviously lacking.
[Aims] To get pharmaceutical companies and Contract Research Organizations (CROs) know the problems occurring in the real field of international clinical trials.
[Methods] From our experiences in international clinical trials on rheumatoid arthritis (RA), we introduce the several true stories ("the tip of the iceberg").
Episode I: As a disposal box for home-administrated syringes, a huge box like a gallon bottle labeled "BIOHAZARD" in English was distributed. In Japan, it is not easy to bring this "huge" "hazardous" box to public transport. At all, RA patients who can carry the huge box may have no functional disorder, so that may not meet the inclusion criteria for clinical trial.
Episode II: Because serum samples were refused to send out due to "holiday in U.S.", the patient's visit needed to be rescheduled. Later, since the re-scheduled date was Japanese public holiday, the visit date was adjusted, but exceeded allowance period. We were forced to prepare the deviation report.
Episode III: Because of measurement equipment failure in the central laboratory, the scheduled date of all subjects were forced to be changed. The central laboratory which collects specimens from all over the world did not have any reserve equipment.
Episode IV: The investigational drug did not reach at our hospital by the day before the scheduled date. Clinical Research Associate (CRA) instructed us by the phone "Please inform the patient to come over to another day". No apologies to the patient from CRA, many apologies from us. A gentle Japanese patient forgave us except CRA.
[Conclusion] CROs in each country should report responsibly these kinds of troubles on the real field to the pharmaceutical companies. The companies also should respond to them sincerely and reflect them to the next trial. It should be kept in mind that consideration for patients and medical staffs in other countries is essential for smooth execution of international clinical trials.

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