Regulatory perspectives on data monitoring

Statistics in Medicine

Volumn 21, Issue 19, 2002, Pages 2831-2842

  O'Neill, Robert T ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

Data monitoring committee; Event charts; Interim analysis; International Conerence on Harmonization; Safety assessment; Visual graphics

Indexed keywords

AMITRIPTYLINE; ATORVASTATIN; DRUG; INFLUENZA VACCINE; LORAZEPAM; SULFAMETHOXAZOLE;

ARTICLE; BLOOD TOXICITY; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DATA ANALYSIS; DRUG EFFICACY; DRUG INDUSTRY; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; GASTROENTERITIS; GOVERNMENT; HUMAN; LIVER TOXICITY; METHODOLOGY; MONITORING; MORBIDITY; MORTALITY; NEUROTOXICITY; PRACTICE GUIDELINE; PUBLICATION; QUALITY CONTROL; SAMPLE SIZE; STATISTICS; TREATMENT OUTCOME;

CLINICAL TRIALS DATA MONITORING COMMITTEES; DATA INTERPRETATION, STATISTICAL; DRUG APPROVAL; DRUG EVALUATION; DRUG MONITORING; HUMANS; RANDOMIZED CONTROLLED TRIALS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0037108139     PISSN: 02776715     EISSN: None     Source Type: Journal    
DOI: 10.1002/sim.1287     Document Type: Article

References (21)

1. DeMets DL, Fleming TR, Whitley RJ, Childress JF, Ellenberg SS, Foulkes M, Mayer KH, O'Fallon J, Pollard RB, Rahal JJ, Sande M, Straus S, Walters L, Whitley-Williams P. The Data and Safety Monitoring Board and Acquired Immune Deficiency Syndrome (AIDS) Clinical Trials. Controlled Clinical Trials 1995; 16:408-421.
2. Code of Federal Regulations. U.S. Government Printing Office, Washington, 2000.
3. Guideline for the 'Format and Content of the Clinical and Statistical Sections of New Drug Applications'. U.S. Department of Health and Human Services, Public Health Service, FDA, July 1988.
4. PMA/FDA Workshop. Clinical Trial Monitoring and Interim Analysis in the Pharmaceutical Industry, Sheraton Washington Hotel, Washington, D.C., February 24-25, 1992.
5. Rockhold FW, Enas GG. Data monitoring and interim analyses in the pharmaceutical industry: ethical and logistical considerations. Statistics in Medicine 1993; 12:471-479.
6. PMA Biostatistics and Medical Ad Hoc Committee on Interim Analysis. Interim analysis in the pharmaceutical industry. Controlled Clinical Trials 1993; 14:160-173.
7. O'Neill RT. Some FDA perspectives on data monitoring in clinical trials in drug development. Statistics in Medicine 1993; 12:601-608.
8. PEST, Planning and Evaluation of Sequential Trials. Medical and Pharmaceutical Research Unit, University of Reading, available at www.Reading.AC.UK.
9. Cytel Software Corporation. EaSt-2000. Cytel Software Corporation, 2000.
10. MathSoft. S +SeqTrial. In S-Plus User's Manual. MathSoft, Inc.: Seattle, Washington, 2000.
11. D'Arcy PF, Harron DWG (eds). Proceedings of the Second International Conference on Harmonization, Orlando 1993, Published at the Queens University of Belfast.
12. D'Arcy PF, Harron DWG (eds). Proceedings of the Third International Conference on Harmonization, Orlando 1995, Published at the Queens University of Belfast.
13. D'Arcy PF, Harron DWG (eds). Proceedings of the Fourth International Conference on Harmonization, Orlando 1997, Published at the Queens University of Belfast.
14. Guidance for Industry, E6 'Good Clinical Practice: Consolidated Guidance', U.S. Department of Health and Human Services, April 1996. Available at www.FDA.GOV/CDER/Guidance/Index.htm.
15. Guidance for Industry, E9 'Statistical Principles for Clinical trials', U.S. Department of Health and Human Services, April 1996. Available at www.FDA.GOV/CDER/Guidance/Index.htm.
16. Goldman AI, Hannan PJ. Optimal continuous sequential boundaries for monitoring toxicity in clinical trials: a restricted search algorithm. Statistics in Medicine 2001; 20:1575-1589.
17. Goldman AI. Issues in designing sequential stopping rules for monitoring side effects in clinical trials. Controlled Clinical Trials 1987; 8:327-337.
18. Thall PF, Simon RM, Estey EH. Bayesian sequential monitoring designs for single-arm clinical trials with multiple outcomes. Statistics in Medicine 1995; 14:357-379.
19. Greenhouse JB, Wasserman L. Robust Bayesian methods for monitoring clinical trials. Statistics in Medicine 1994; 14:1379-1391.
20. Lan KKG, Friedman L. Monitoring boundaries for adverse effects in long-term clinical trials. Controlled Clinical Trials 1986; 7:1-7.
21. Lee JJ, Hess KR, Dubin JA. Extensions and applications of events charts. The American Statistician 2000; 54:63-70.