Integrity of Scientific Data: Transparency of Clinical Trial Data
Tài liệu tham khảo
Rhodes, 2004, Whistleblowing in academic medicine, J Med Ethics, 30, 35, 10.1136/jme.2003.005553
Kansu, 2002, Research ethics and scientific misconduct in biomedical research, Acta Neurochir Suppl, 83, 11
de Pracontal, 2005
Lock, 2002
Broad, 1987
Mathews, 2006, Fraud, errors taint a key study of widely used Sanofi drug; despite some faked results, FDA approves antibiotic; one doctor’s cocaine use; company defends safety, Wall St J (East Ed), A1
Couzin, 2006, Scientific misconduct. Fraud upends oral cancer field, casting doubt on prevention trial, Science, 311, 448, 10.1126/science.311.5760.448a
Mathews, 2005, Playing detective: at medical journal, editor finds truth hard to track down; termite-eaten data plague Dr. Smith’s 12-year probe of an Indian researcher, Wall St J (East Ed), A1
Al-Marzouki, 2005, The effect of scientific misconduct on the results of clinical trials: a Delphi survey, Contemp Clin Trials, 26, 331, 10.1016/j.cct.2005.01.011
Ranstam, 2000, Fraud in medical research: an international survey of biostatisticians. ISCB Subcommittee on Fraud, Control Clin Trials, 21, 415, 10.1016/S0197-2456(00)00069-6
Gardner, 2005, Authors’ reports about research integrity problems in clinical trials, Contemp Clin Trials, 26, 244, 10.1016/j.cct.2004.11.013
Safer, 2002, Design and reporting modifications in industry-sponsored comparative psychopharmacology trials, J Nerv Ment Dis, 190, 583, 10.1097/00005053-200209000-00002
Buyse, 1999, The role of biostatistics in the prevention, detection and treatment of fraud in clinical trials, Stat Med, 18, 3435, 10.1002/(SICI)1097-0258(19991230)18:24<3435::AID-SIM365>3.0.CO;2-O
Al-Marzouki, 2005, Are these data real? Statistical methods for the detection of data fabrication in clinical trials, BMJ, 331, 267, 10.1136/bmj.331.7511.267
Bostanci, 2002, Research misconduct. German inquiry finds flaws, not fraud, Science, 298, 1531, 10.1126/science.298.5598.1531b
DeMets, 1997, Distinctions between fraud, bias, errors, misunderstanding, and incompetence, Control Clin Trials, 18, 637, 10.1016/S0197-2456(97)00010-X
Nylenna, 2006, Scientific misconduct: a new approach to prevention, Lancet, 367, 1882, 10.1016/S0140-6736(06)68821-1
Dyer, 1996, GP struck off for fraud in drug trials, BMJ, 312, 798, 10.1136/bmj.312.7034.798a
http://blackwellpublishing.com/publicationethics/
http://www.clinicaltrials.gov.
http://www.ifpma.org/clinicaltrials.