Combining mortality and longitudinal measures in clinical trials.
Clinical trials often assess therapeutic benefit on the basis of an event such as death or the diagnosis of disease. Usually, there are several additional longitudinal measures of clinical status which are collected to be used in the treatment comparison. This paper proposes a simple non-parametric test which combines a time to event measure and a longitudinal measure so that a substantial treatment difference on either of the measures will reject the null hypothesis. The test is applied on AIDS prophylaxis and paediatric trials.
Biostatistics Department, Harvard School of Public Health, Boston, MA 02115, USA. dfinkel@sdac.harvard.edu
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Finkelstein
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Schoenfeld
D000163:Acquired Immunodeficiency Syndrome / Q000401:mortality*; D019380:Anti-HIV Agents / Q000627:therapeutic use; D000890:Anti-Infective Agents / Q000627:therapeutic use; D000935:Antifungal Agents / Q000627:therapeutic use; D002177:Candidiasis / Q000517:prevention & control; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D003022:Clotrimazole / Q000627:therapeutic use; D003622:Dapsone / Q000627:therapeutic use; D016049:Didanosine / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D015725:Fluconazole / Q000627:therapeutic use; D006257:Head / Q000254:growth & development; D006801:Humans; D008137:Longitudinal Studies; D010419:Pentamidine / Q000627:therapeutic use; D011020:Pneumonia, Pneumocystis / Q000517:prevention & control; D018709:Statistics, Nonparametric; D016896:Treatment Outcome; D015662:Trimethoprim, Sulfamethoxazole Drug Combination / Q000627:therapeutic use; D015215:Zidovudine / Q000627:therapeutic use
D019380:Anti-HIV Agents; D000890:Anti-Infective Agents; D000935:Antifungal Agents; D015215:Zidovudine; D010419:Pentamidine; D015662:Trimethoprim, Sulfamethoxazole Drug Combination; D015725:Fluconazole; D003622:Dapsone; D003022:Clotrimazole; D016049:Didanosine