Data and safety monitoring in the Delta trial.
Delta was a randomized trial designed to test whether combinations of zidovudine (AZT) with didanosine (ddI) or zalcitabine (ddC) were more effective than AZT alone for HIV-infected persons. A Data and Safety Monitoring Committee (DSMC) monitored accumulating data. This paper describes the deliberations and recommendations of the DSMC, as clear-cut differences in efficacy gradually emerged during the later stages of the trial.
Armitage
P
P
St. Peter's College, Oxford, United Kingdom.
D000163:Acquired Immunodeficiency Syndrome / Q000188:drug therapy* / Q000401:mortality; D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016049:Didanosine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D006801:Humans; D015337:Multicenter Studies as Topic; D016032:Randomized Controlled Trials as Topic / Q000379:methods* / Q000592:standards; D016019:Survival Analysis; D016047:Zalcitabine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D015215:Zidovudine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
D019380:Anti-HIV Agents; D015215:Zidovudine; D016047:Zalcitabine; D016049:Didanosine