Considerations in choice of a clinical endpoint for AIDS clinical trials

Statistics in Medicine

Volumn 13, Issue 19-20, 1994, Pages 2107-2125

  Neaton, James D ^a   Wentworth, Deborah N ^a   Rhame, Frank ^b   Hogan, Carlton ^a   Abrams, Donald I ^c   Deyton, Lawrence ^d  

^a UNIVERSITY OF MINNESOTA   (United States)

^b UNIVERSITY OF MINNESOTA   (United States)

^c UNIVERSITY OF CALIFORNIA   (United States)

^d NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIVIRUS AGENT;

ACQUIRED IMMUNE DEFICIENCY SYNDROME; CLINICAL TRIAL; CONFERENCE PAPER; DIAGNOSTIC ACCURACY; DISEASE COURSE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; SURVIVAL;

ACQUIRED IMMUNODEFICIENCY SYNDROME; AIDS-RELATED OPPORTUNISTIC INFECTIONS; CLINICAL TRIALS; DATA INTERPRETATION, STATISTICAL; DISEASE PROGRESSION; HUMAN; MODELS, STATISTICAL; SURVIVAL ANALYSIS; TREATMENT OUTCOME;

EID: 0028076195     PISSN: 02776715     EISSN: 10970258     Source Type: Journal    
DOI: 10.1002/sim.4780131919     Document Type: Article

References (50)

1. Revision of the CDC surveillance case definition for acquired immunodeficiency syndrome
2. The efficacy of azidothymidine (AZT) in the treatment of patients with AIDS and AIDS‐related complex
3. Zidovudine in asymptomatic human immunodeficiency virus infection: a controlled trial in persons with fewer than 500 CD4‐positive cells per cubic millimeter
4. The safety and efficacy of zidovudine (AZT) in the treatment of subjects with mildly symptomatic human immunodeficiency virus type 1 (HIV) infection
5. The efficacy of inosine pranobex in preventing the acquired immunodeficiency syndrome in patients with human immunodeficiency virus infection
6. A randomized controlled trial of a reduced daily dose of zidovudine in patients with acquired immunodeficiency syndrome
7. A controlled trial of early versus late treatment with zidovudine in symptomatic human immunodeficiency virus infection: results of the Veterans Affairs Cooperative Study
8. A controlled trial comparing zidovudine with didanosine in human immunodeficiency virus infection
9. Didanosine for zidovudine‐intolerant patients with HIV disease (Letter to the Editor)
10. Preliminary analysis of the Concorde trial (Letter to the Editor)
11. Zidovudine in persons with asymptomatic HIV infection and CD4 + cell counts greater than 400 per cubic millimeter
12. Didanosine compared with continuation of zidovudine in HIV‐infected patients with signs of clinical deterioration while receiving zidovudine
13. A comparitive trial of didanosine and zalcitabine in patients with human immunodeficiency virus infection who are intolerant of or have failed zidovudine therapy
14. Laboratory markers as potential surrogates for clinical outcomes in AIDS trials
15. Searching for markers on the AIDS trail
16. Evaluating therapeutic interventions: some issues and experiences
17. Modeling the relationship between survival and CD4 lymphocytes in patients with AIDS and AIDS‐related complex
18. + lymphocytes are an incomplete surrogate marker for clinical progresion in persons with asymptomatic HIV infection taking zidovudine
19. Considerations in the selection of end points for AIDS clinical trials
20. The use of subjective rankings in clinical trials with an application to cardiovascular disease
21. Left ventricular ejection fraction may not be useful as an endpoint of thrombolytic therapy comparative trials
22. Nonparametric estimation from incomplete observations
23. Regression models and life‐tables
24. On the regression analysis of multivariate failure time data
25. Regression analyses of multivariate incomplete failure time data by modelling marginal distributions
26. Procedures for combining examples with multiple endpoints
27. The analysis of multiple endpoints in clinical trials
28. Non‐parametric sequential testing in clinical trials with incomplete multivariate observations
29. A new endpoint for the assessment of adjuvant therapy in postmenopausal women with operable breast cancer
30. Need an endpoint for a clinical trial? Just ask’, (abstract)
31. A method of assigning scores to the components of a composite outcome: an example from the MITI Trial
32. Increased gastric pH and the bioavailability of fluconazole and ketoconazole
33. Failure of prophylaxis with dapsone in patients taking dideoxyinosine (letter)
34. HIV with reduced sensitivity to zidovudine (AZT) isolated during prolonged therapy
35. Inosine pranobex ‐ is a single positive trial enough?
36. Bias despite masked assessment of clinical outcomes when an outcome is defined as one of several component events
37. Sample sizes of medical trials with special reference to long term therapy
38. Sample sizes based on the log‐rank statistic in complex clinical trials
39. Survival: the ultimate endpoint’, in Abrams, D., Cotton, D. and Mayer, K. (eds)