SY 02-3 RESOLVING ETHICAL PROBLEMS IN HYPERTENSION TREATMENT TRIALS

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Abstract

Since a concept of Evidence-based Medicine appeared in medical field in 1991, modern medical treatment have been remarkably changed.

However, delusive belief of EBM without criticism has brought negative aspect, such as utilization of EBM by companies as a tool of promotion of drug or medical device.

Although most of clinical trials were financially supported by drug companies. result of clinical trial does not always ended in favor of test drug or device. When negative results appeared, various way were taken by industry such as usage of SPIN, emphasizing secondary endpoint.

PROBE method has been more frequently in the Japanese clinical trials as a feasible alternative of double blind method. However there is a rule that soft endpoint, which is more likely to be affected by intention of doctor must not be contained.

Unfortunately, a big scandal surrounding the blood pressure-lowering drug Diovan came to light in 2013 and developed into an unprecedented arrest of a ex-employee of drug company for the suspicion of violation of the Pharmaceutical Law.

Jikei Heart study or Kyoto Heart study which were retracted on the reason of a excessive error of the data and a suspicion of misconduct.

According to investigative committee of the each university, there are too many intentional discrepancy between original record and analyzed data, which are not attributable PROBE method.

Several reasons for the misconduct can be raised in Diovan case. Fistly, moral of both investigator and pharmacy were lacking. Secondary, knowledge of investigators about clinical trials and statistics were scarce too much.

Thirdly, clinical studies have been started in the circumstance in which insufficient infrastructure development of Japan.

Fourthly, opaque and sometimes questionable ties between medical researchers and pharmaceutical company can be raised.

I will give a speech about medical moral to prevent misconduct of clinical research.

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