fraud in medical research - home - bibliotheca alexandrina.pptVIP

Fraud in Medical Research: Emphasis on Statistical Aspects Ted Colton, ScD Professor Chair Emeritus Department of Epidemiology Biostatistics A Continuum with Fuzzy Boundaries Fraud Cheating Misconduct Ignorance, Naiveté Carelessness, Sloppiness Improper methods Statistical ‘fallacies’ Types of Fraud Plagiarism - not dealt with in this talk Falsification – data alteration Fabrication – made-up data Motivation for Fraud Obtain a desired result, e.g. ‘statistical significance’ Monetary gain, enhancement of prestige Compensate for laziness, sloppiness in data collection Include subjects who would otherwise be excluded Some Historical Instances of Fraud Gregor Mendel Date: 1865 Place: Bohemia Research: Genetics of garden peas Sir Cyril Burt Date: 1955-66 Place: Great Britain Research: IQs of identical twins reared apart and reared together Dr. John Darsee Date: 1981 Place: Harvard Medical School, Peter Bent Brigham Hospital Research: Laboratory and animal studies of cardiovascular disease Data Items in Clinical TrialsProne to Fraud Eligibility criteria Repeated measurements Adverse events Compliance Subject diaries Questions for Consideration How was fraud detected? Why was fraud committed? What have been the consequences of fraud? Statistically, how do we handle data when some data are suspected or confirmed as fraudulent? Can we use statistical methods to detect or confirm suspected instances of fraud? What measures, if any, can we take to prevent future episodes of fraud? Dr. Marc Strauss Date: 1978 Place: Boston University Medical Center Research: Multi-center clinical trials of cancer, ECOG Dr. Roger Poisson Date: 1992 Place: St. Luc’s Hospital, Montreal Research: Multi-center clinical trial of lumpectomy vs. radical mastectomy in treatment of breast cancer, NSABP St. Mary’s Hospital Date: 1994 Place: St. Mary’s Hospital, Montreal Research: Breast Cancer Prevention Trial, NSABP St. Mary’s Incident – DSMB Recommendations A thorough audit of all