Errors, misunderstandings, and fraud

Controlled Clinical Trials

Volumn 18, Issue 6, 1997, Pages 661-666

  Williams, George W ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

Author keywords

Analysis; Auditing; Design; Quality control

Indexed keywords

CLINICAL TRIAL; CONFERENCE PAPER; CONTROLLED CLINICAL TRIAL; ERROR; HUMAN; QUALITY CONTROL; RANDOMIZED CONTROLLED TRIAL; TECHNIQUE;

EID: 0030853196     PISSN: 01972456     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0197-2456(97)82057-0     Document Type: Conference Paper

References (13)

1. Alberts B, Shine K. Scientists and the integrity of research. Science 1994;266: 1660-1661.
2. Smigel K. Top cancer-related news stories focus on fraud, breast cancer, and the hope of early detection. JNCI 1995;87:12-14.
3. Association of the British Pharmaceutical Industry. Fraud and malpractice in the context of clinical research. J Roy Col Phys London 1993;27:45-46.
4. Lederberg J. Sloppy research extracts a greater toll than misconduct. Science 1995;9:13.
5. Zelen M, Carbone P, Harrington D, et al. Data integrity and fraud in cancer clinical trials: what are the options? Panel Discussion. Joint Statistical Meetings, Orlando, Florida, August 14, 1995.
6. DeMets, DL. Data integrity in clinical trials: looking back at 25 years. Presentation at International Biometric Society Eastern North American Region Spring Meeting, Birmingham, Alabama, March 28, 1995.
7. Peto, R. Statistics of chronic disease control. Nature 1992;356:557-558.
8. Meinert CL. Clinical Trials: Design, Conduct, and Analysis. New York: Oxford University Press; 1986.
9. Harlan WR. Fraud in Clinical Trials: Prevention, Detection, and Consequences. Johns Hopkins Medical Institutions, Baltimore, MD, June 1995.
10. Cohen J. Clinical trial monitoring: hit or miss? Science 1994;264:534-537.
11. Meinert CL. Fraud in clinical trials: Introduction; Quality assurance: what is it and who does it?; Record auditing: what is it and what does it produce? Fraud in Clinical Trials: Prevention, Detection, and Consequences. Johns Hopkins Medical Institutions, Baltimore, MD, June 1995.
12. Persantine-Aspirin Reinfarction Study Research Group: Persantine and aspirin in coronary heart disease. Circulation 1980;62:449-461.
13. Clarke PA. Data validation. In: Rondel RK, Varley SA, Webb LF. Clinical Data Management. New York: John Wiley and Sons; 1993.