Secondary endpoints cannot be validly analyzed if the primary endpoint does not demonstrate clear statistical significance

Controlled Clinical Trials

Volumn 18, Issue 6, 1997, Pages 550-556

  O'Neill, Robert T ^a  

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

Author keywords

Hypothesis tests; p values; Primary endpoints; Secondary endpoints; Statistical adjustments; Valid inference

Indexed keywords

DRUG;

CLINICAL TRIAL; CONFERENCE PAPER; HUMAN; HYPOTHESIS; SAMPLE; STATISTICS; TREATMENT OUTCOME;

CLINICAL TRIALS; HUMANS; MORTALITY; OUTCOME ASSESSMENT (HEALTH CARE); REPRODUCIBILITY OF RESULTS; SAMPLE SIZE;

EID: 0030694389     PISSN: 01972456     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0197-2456(97)00075-5     Document Type: Conference Paper

References (5)

1. CPMP Working Party and Efficacy of Medicinal Products. Note for guidance: biostatistical methodology in clinical trials in applications for marketing authorization for medical products. Stat Med 1995;14:1659-1682.
2. Capizzi T, Zhang JI. Testing the hypothesis that matters for multiple primary endpoints. Drug Info J 1996;30:949-956.
3. Bristol DR. Sample sizes for constructing confidence intervals and testing hypotheses. Stat Med 1989;8:803-811.
4. Hung HMJ, O'Neill R, Bauer P, Kohne K. The behavior of the p-value when the alternative hypothesis is true. Biometrics 1997;53:11-22.
5. Goodman SN. A comment on replication, p-values and evidence. Stat Med 1992; 11:875-879.