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Errors were made about a study by the Academic Medical Center (AMC) on bile duct cancer. The study was discontinued in 2016 after the death of many more participants than expected. The surviving participants and the next of kin were not informed of the premature end in time. The CMA Medical Ethics Review Panel (METC) also did not report to the Central Committee for Humans Research (CCMO).
This emerges from a report published by the CCMO on the conduct of the investigation. The CCMO conducted the analysis in response to the CN reports on this abandoned study and the parliamentary questions that followed.
The study of biliary cancer took place between 2013 and 2016. The AMC researchers compared two existing methods in the study to eliminate excess bile from the liver so to study the complications. This happened in 54 cancer patients. At 27 participants, they brought a galbouse through the throat – three of them died. With the other 27 participants, the tube passed through the skin and through the liver. Up to eleven of these patients died subsequently. The dead were completely unexpected. The study was stopped immediately.
Report
Neither the researchers nor the medical ethics committee, who were aware of the progress of the investigation, subsequently reported to the CCMO. The Inspectorate for Health and Youth (IGJ) was also uninformed. It also lasted until March 6, 2018, a year and a half after the premature end of the study, before subjects and relatives were informed of the reasons for the abandonment.
The CCMO finds this period far too long, according to the report. The committee concludes that the review committee evaluated the research proposal "adequately and carefully", but that it did not inform in a timely manner the subjects of the suspension and the end premature survey. "The CCMO believes that the METC plays a monitoring role by ensuring that the provision of information to participants in a temporarily suspended investigation is completed appropriately." In this respect, the AMC METC failed in its evaluation task. "The METC should also have reported premature termination to the CCMO within seven days and should reflect on its role in the entire assessment process, but that did not happen.
Analysis
About not informing the subjects at the time told the CMA to have chosen to analyze the data from the study first and then report them only afterwards. to participants. "Of course, we wanted to inform all participants," said principal investigator Thomas van Gulik, "but only after being able to clarify why the research was stopped." The CMA announces the recommendations of the CCMO. "The METC and the AMC will take a closer look at the way and the moment to inform patients who are involved in an abandoned study," according to the hospital.
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