Interval estimates of the probability of toxicity at the maximum tolerated dose for small samples

Statistics in Medicine

Volumn 22, Issue 11, 2003, Pages 1829-1836

  Natarajan, Loki ^a   O'Quigley, John ^a,b  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b INSERM   (France)

Author keywords

Clinical trials; Continual reassessment method; Dose finding studies; Maximum likelihood; Phase I trials; Toxicity

Indexed keywords

ACCURACY; ARTICLE; CALCULATION; CONFIDENCE INTERVAL; HUMAN; MAXIMUM TOLERATED DOSE; METHODOLOGY; PROBABILITY; SAMPLE SIZE; SIMULATION; TOXICITY TESTING;

ANTINEOPLASTIC AGENTS; CLINICAL TRIALS, PHASE I; DRUG EVALUATION; HUMANS; MAXIMUM TOLERATED DOSE; NEOPLASMS; PROBABILITY; RISK; SAMPLE SIZE;

EID: 0037614842     PISSN: 02776715     EISSN: None     Source Type: Journal    
DOI: 10.1002/sim.1443     Document Type: Article

References (6)

1. O'Quigley J, Pepe M, Fisher L. Continual reassessment method: a practical design for phase I clinical studies in cancer. Biometrics 1990; 46:33-48.
2. Shen L, O'Quigley J. Consistency of continual reassessment method under model misspecification. Biometrika 1996; 83(2):395-405.
3. O'Quigley J. Estimating the probability of toxicity at the recommended dose following a phase I clinical trial in cancer. Biometrics 1992; 48:853-862.
4. O'Quigley, J. Continual reassessment method. In Handbook of Statistics in Clinical Oncology, Crowley J (ed.). Marcel Dekker: New York, 2001; 35-72.
5. Barndorff-Nielsen OE, Cox DR. Asymptotic Techniques for Use in Statistics. Chapman & Hall: London, 1989; 117.
6. Reiner E, Paoletti X, O'Quigley J. Errors due to stopping rules in phase I cancer trials. Computational Statistics and Data Analysis 1999; 30:303-315.