Choosing the analysis population in non-inferiority studies: Per protocol or intent-to-treat

Statistics in Medicine

Volumn 25, Issue 7, 2006, Pages 1169-1181

  Sanchez, M Matilde ^a   Chen, Xun ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

Author keywords

Drop out due to lack of efficacy; Hybrid ITT PP analysis; LVCF method; MLE method; Non compliance; Non trivial missing

Indexed keywords

ANALYSIS OF COVARIANCE; ANALYTICAL ERROR; ARTICLE; EFFECTIVE POPULATION SIZE; HUMAN; LONGITUDINAL STUDY; METHODOLOGY; POWER ANALYSIS; PREDICTION; RELIABILITY; SAMPLE SIZE; SIMULATION; STATISTICAL ANALYSIS; STATISTICAL MODEL; TREATMENT RESPONSE; VALIDATION PROCESS;

ANALYSIS OF VARIANCE; CLINICAL PROTOCOLS; COMPUTER SIMULATION; CONTROLLED CLINICAL TRIALS; DATA INTERPRETATION, STATISTICAL; DRUG EVALUATION; HUMANS; LIKELIHOOD FUNCTIONS; MODELS, STATISTICAL; PATIENT DROPOUTS; REFUSAL TO PARTICIPATE; RESEARCH DESIGN; SENSITIVITY AND SPECIFICITY; SOFTWARE; TREATMENT OUTCOME;

EID: 33645474076     PISSN: 02776715     EISSN: 10970258     Source Type: Journal    
DOI: 10.1002/sim.2244     Document Type: Article

References (12)

1. ICH Harmonised Tripartite Guideline. E9: statistical principles for clinical trials, 1998.
2. Ebbutt AF, Firth L. Practical issues in equivalence trials. Statistics in Medicine 1998; 1691-1701.
3. Rohmel J. Therapeutic equivalence investigations: statistical considerations. Statistics in Medicine 1998; 17: 1703-1714.
4. Garrett AD. Therapeutic equivalence: fallacies and falsification. Statistics in Medicine 2003; 22:741-762.
5. D'Agostino RB, Massaro JM, Sullivan LM. Non-inferiority trials: design concepts and issues - the encounters of academic consultants in statistics. Statistics in Medicine 2003; 22:169-186.
6. Committee on Proprietary Medical Products Point-to-Consider. Points to consider on switching between superiority and non-inferiority. CPMP, 2000.
7. Jones B, Jarvis P, Lewis JA, Ebbutt AF. Trials to assess equivalence: the importance of rigorous methods. British Medical Journal 1996; 313:36-39.
8. Lachin JM. Statistical considerations in the intent-to-treat principle. Controlled Clinical Trials 2000; 21:167-189.
9. Rubin, Donald B. Inference and missing data. Biometrika 1976; 63:581-590.
10. Laird NM, Ware JH. Random-effects models for longitudinal data. Biometrics 1982; 38:963-974.
11. ICH Harmonised Tripartite Guideline. E1O: choice of control group and related issues in clinical trials, 2000.
12. Temple R. Difficulties in evaluating positive control trials. ASA Proceedings of the Biopharmaceutical Statistics 1983; 1-7.