Data and safety monitoring in the Delta trial

Controlled Clinical Trials

Volumn 20, Issue 3, 1999, Pages 229-241

  Armitage, Peter ^a,b  

^a UNIVERSITY OF OXFORD   (United Kingdom)

^b MRC CLINICAL TRIALS UNIT   (United Kingdom)

Author keywords

AIDS trials; Data and safety monitoring; HIV infection; Interim analyses; Survival data

Indexed keywords

DIDANOSINE; ZALCITABINE; ZIDOVUDINE;

ADULT; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; INFORMATION PROCESSING; MAJOR CLINICAL STUDY; MONITORING; MULTICENTER STUDY; ORGANIZATION; RANDOMIZED CONTROLLED TRIAL; SURVIVAL RATE;

EID: 0032919460     PISSN: 01972456     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0197-2456(99)00003-3     Document Type: Article

References (6)

1. Delta Coordinating Committee. Delta: a randomised double-blind controlled trial comparing combinations of zidovudine plus didanosine or zalcitabine with zidovudine alone in HIV-infected individuals. Lancet 1996;348:283-291.
2. Concorde Coordinating Committee. Concorde: MRC/ANRS randomised double-blind controlled trial of immediate and deferred zidovudine in symptom-free HIV infection. Lancet 1994;343:871-881.
3. Alpha International Coordinating Committee. The Alpha trial: European/Australian randomised double-blind trial of two doses of didanosine in zidovudine-intolerant patients with symptomatic HIV disease. AIDS 1996;10:867-880.
4. Armitage, P. Data and Safety Monitoring in the Concorde and Alpha Trials. Control Clin Trials 1999;20:207-228.
5. Armitage P. Interim analysis in clinical trials. Stat Med 1991;10:925-937.
6. Fischl MA, Stanley K, Collier AC, et al. Combination and monotherapy with zidovudine and zalcitabine in patients with advanced HIV disease. Ann Intern Med 1995;122:24-32.