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Anasayfa : Haberler : FDA American Heart Association başkanının klinik araştırma yapmasını kısıtladı..

FDA American Heart Association başkanının klinik araştırma yapmasını kısıtladı..

Aspirin ile karşılaştırmalı çalışma yapan AHA başkanı çalışma protokolüne uymadığı için 3 yıl süre ile klinik araştırmaları kısıtlandı.  

FDA limits research of former AHA president for submitting false information

Janice Hopkins Tanne, New York

Just days before he completed his year as president of the American Heart Association on 30 June, Dr David Faxon signed a consent agreement with the Food and Drug Administration limiting his clinical research.

On 19 June 2002 Dr Faxon agreed that for three years he would not be the principal investigator for more than two FDA regulated clinical investigations at any one time, and that he would not be the principal clinical investigator for a study that enrolled more than 25 subjects.

The agreement follows an investigation into Dr Faxon`s work, which was held from October to November in 1999 when he was chief of cardiology at the University of Southern California in Los Angeles. The FDA inspected his clinical study, comparing a new drug with aspirin to see which gave better protection from ischaemic heart events after acute coronary syndromes.

After its investigation, the FDA complained that Dr Faxon failed to personally conduct or supervise the clinical investigation, that he submitted false information to the trial sponsor, and that he failed to conduct the study in accordance with the approved protocol. He was also found not to have kept adequate and accurate case histories and not to have provided a Spanish version of the informed consent document to people whose first language was Spanish, not English.

The complaint cited examples of records being falsified to alter the duration of chest pain; changes in the records that led to the inclusion of patients who were not eligible for inclusion; patients being included despite being enrolled after the time limits; patients being included when they were receiving drugs that should have excluded them.

Dr Faxon answered the FDA in December 1999, saying his study`s coordinator was responsible for misrepresentation of data and he had no knowledge of the practice. The FDA rejected his response: "We remind you that you are responsible for personally conducting and supervising the clinical investigations since you are the investigator of record. Therefore, we consider your explanation unacceptable."

In April 2000, the FDA sent Dr Faxon a "Notice of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOE)." Few clinical investigators receive such a notice. In 2000, Dr Faxon was one of only six to receive one. In 2001 there were four, and so far this year there have been two.

In July 2000, Dr Faxon became section chief of cardiology and professor of medicine at the University of Chicago

 

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