Monitoring and evaluating clinical trials data

Intensive Care Medicine, Supplement

Volumn 26, Issue 1, 2000, Pages

  Whitehead, J ^a  

^a UNIVERSITY OF READING   (United Kingdom)

Author keywords

Clinical trials; Interim analyses; Sample size; Sequential methods; Stopping rules

Indexed keywords

ANTIBIOTIC AGENT;

CLINICAL TRIAL; CONFERENCE PAPER; DATA ANALYSIS; HUMAN; INTENSIVE CARE; MONITORING; SEPTIC SHOCK;

CLINICAL TRIALS; HUMANS; RESEARCH DESIGN; SAMPLE SIZE; SHOCK, SEPTIC; STATISTICS;

EID: 0034026227     PISSN: 09351701     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Conference Paper

References (13)

1. Machin D, Campbell MJ, Fayers PM, Pinol APY (1997) Sample size tables for clinical studies (2nd edn). Blackwell Science, Oxford
2. nQuery Advisor Release 3.0 (1999) Statistical Solutions Ltd., Cork, Ireland
3. Armstrong PW, Furberg CD (1995) Clinical trial data and safety monitoring boards: the search for a constitution. Circulation 91: 901-904
4. Whitehead J (1999) On being the statistician on a data and safety monitoring board. Statistics Med 18: 3425-3434
5. Bolland KM, Whitehead J (2000) Formal approaches to safety monitoring of clinical trials in life-threatening conditions. Statistics Med 19 (in press)
6. Gould AL (1992) Interim analyses for monitoring clinical trials that do not materially affect the type I error rate. Statistics Med 11: 55-56
7. Gould AL (1995) Planning and revising the sample size for a trial. Statistics Med 14: 1039-1051
8. Whitehead J (1997) The design and analysis of sequential clinical trials, (revised 2nd edn) Wiley, Chichester
9. Whitehead J (1993) Application of sequential methods to a phase III clinical trial in stroke. Drug Inform J 27: 733-740
10. Moss AJ, Hall WJ, et al (1996) Improved survival with implanted defibrillator in patients with coronary disease at high risk for ventricular arrhythmia. N Engl J Med 335: 1933-1940
11. Medical Research Council Renal Cancer Collaborators (1999) Interferon-α and survival in metastatic renal carcinoma: early results of a randomised controlled trial. Lancet 353: 14-17
12. Fayers PM, Cook PA, Machin D, Donaldson N, Whitehead J, Ritchie A, Oliver RTD, Yuen P (1994) On the development of the Medical Research Council trial of α-interferon in metastatic renal carcinoma. Statistics Med 13: 2249-2260
13. Lewis RJ, Bessen HA (1990) Sequential clinical trials in emergency medicine. Ann Emerg Med 19: 1047-1053