Experience with a cross-study endpoint review committee for AIDS clinical trials

AIDS

Volumn 12, Issue 15, 1998, Pages 1983-1990

  Green, Lisa A ^a   Rhame, Frank S ^b   Price, Richard W ^c   Perlman, David C ^d   Capps, Linnea G ^e   Sampson, James H ^f   Deyton, Lawrence R ^g   Schnittman, Steven M ^h   Fisher, Evelyn J ⁱ   Bartsch, Glenn E ^a   Krum, Eric A ^a   Neaton, James D ^a  

^a UNIVERSITY OF MINNESOTA   (United States)

^b ABBOTT NORTHWESTERN HOSPITAL   (United States)

^c SAN FRANCISCO GENERAL HOSPITAL   (United States)

^d BETH ISRAEL MEDICAL CENTER   (United States)

^e Harlem AIDS Treatment Group   (United States)

^f Research and Education Group   (United States)

^g DEPARTMENT OF VETERANS AFFAIRS   (United States)

^h BRISTOL MYERS SQUIBB   (United States)

ⁱ Richmond AIDS Consortium   (United States)

Author keywords

AIDS clinical trials; Clinical events; Endpoint committee; Endpoint review; Progression of HIV disease

Indexed keywords

ACQUIRED IMMUNE DEFICIENCY SYNDROME; ARTICLE; CLINICAL RESEARCH; CLINICAL TRIAL; DATA ANALYSIS; DISEASE COURSE; DOCUMENTATION; HEALTH CARE ORGANIZATION; HUMAN; MAJOR CLINICAL STUDY; META ANALYSIS; PRIORITY JOURNAL; STANDARDIZATION; TREATMENT OUTCOME; TREATMENT PLANNING;

EID: 7844243605     PISSN: 02699370     EISSN: None     Source Type: Journal    
DOI: 10.1097/00002030-199815000-00009     Document Type: Article

References (36)

1. Greenland S: Variance estimation for epidemiologic effect estimates under misclassification. Stat Med 1988, 7:745-757.
2. Wacholder S, Lubin JF, Docemeci M, Gail MH: Bias despite masked assessment of clinical outcome when an outcome is defined as one of several component events. Control Clin Trials 1991, 12:457-461.
3. White E: The effect of misclassification of disease status in follow-up studies: implications for selecting disease classification criteria. Am J Epidemiol 1986, 124:816-825.
4. Pocock SJ: Clinical Trials: A Practical Approach. Chichester: John Wiley and Sons; 1983:123-141.
5. Larntz K, Neaton JD, Wentworth DN, Yurik T: Data analysis issues for protocols with overlapping enrollment. Stat Med 1996, 15:2445-2453.
6. Centers for Disease Control: Revision of the CDC surveillance case definition for acquired immunodeficiency syndrome. MMWR 1987, 36 (suppl):1S-15S.
7. Neaton JD, Wentworth DN, Rhame F, Hogan C, Abrams DI, Deyton L: Considerations in choice of a clinical endpoint for AIDS clinical trials. Stat Med 1994, 13:2107-2125.
8. Delta Coordinating Committee: Delta: a randomized double-blind controlled trial comparing combinations of zidovudine plus didanosine or zalcitabine with zidovudine alone in HIV-infected individuals. Lancet 1996, 348:283-291.
9. Cooper DA, Gatell JM, Kroon S, et al.: Zidovudine in persons with asymptomatic HIV infection and CD4+ cell counts greater than 400 per cubic millimeter. N Engl J Med 1993, 329:297-303.
10. Concorde Coordinating Committee: Concorde: MRC/ANRS randomized double-blind controlled trial of immediate and deferred zidovudine in symptom-free HIV infection. Lancet 1994, 343:871-881.
11. 3. Ann Intern Med 1995, 123:561-571.
12. Volberding PA, Lagakos SW, Koch MA, et al.: Zidovudine in asymptomatic human immunodeficiency virus infection. A controlled trial in persons with fewer than 500 CD4-positive cells per cubic millimeter. N Engl J Med 1990, 322:941-949.
13. Dolin R, Amato DA, Fischl MA, et al.: Zidovudine compared with didanosine in patients with advanced HIV type 1 infection and little or no previous experience with zidovudine. Arch Intern Med 1995, 155:961-974.
14. Kahn JO, Lagakos SW, Richman DD, et al.: A controlled trial comparing continued zidovudine with didanosine in human immunodeficiency virus infection. N Engl J Med 1992, 327:581-587.
15. Fischl MA, Richman DD, Hansen N, et al.: The safety and efficacy of zidovudine (AZT) in the treatment of subjects with mildly symptomatic human immunodeficiency virus type 1 (HIV) infections. Ann Intern Med 1990, 112:727-737.
16. Spruance SL, Pavia AT, Peterson D, et al.: Didanosine compared with continuation of zidovudine in HIV-infected patients with signs of clinical deterioration while receiving zidovudine. Ann Intern Med 1994, 120:360-368.
17. Mannucci PM, Gringeri A, Savidge G, et al.: Randomized double-blind, placebo-controlled trial of twice-daily zidovudine in asymptomatic haemophiliacs infected with the human immunodeficiency virus type 1. Br J Haematol 1994, 86:174-179.
18. Merigan TC, Amato DA, Balsley J, et al.: Placebo-controlled trial to evaluate zidovudine in treatment of human immunodeficiency virus infection in asymptomatic patients with hemophilia. Blood 1991, 78:900-906.
19. Price R, Daniels K, Rhame F, et al.: Progression of HIV disease: definitions, criteria, and data processing systems of CPCRA. VIII International Conference on AIDS. Amsterdam, July 1992 [abstract PoC4510].
20. Green LA, Neaton JD, Bartsch G, et al.: A clinical event system with committee review for a large clinical trials network [abstract]. Control Clin Trials 1994, 15:57A.
21. Deyton L, Carlyn M, Hedderman M, Maiatico C, Hoth D, Fauci A: A national community-based AIDS research program: the Community Programs for Clinical Research on AIDS (CPCRA). VII International Conference on AIDS. Florence, June 1991 [abstract WB2448].
22. Centers for Disease Control: 1993 Revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. MMWR 1992, 41 (RR-17):1-19.
23. DeMets DL, Fleming TR, Whitley RJ, et al.: The data and safety monitoring board and acquired immune deficiency syndrome (AIDS) clinical trials. Control Clin Trials 1995, 16:408-421.
24. Leoung GS, Feigal DW, Montgomery AB, et al.: Aerosolized pentamidine for prophylaxis against Pneumocystis carinii pneumonia. The San Francisco Community Prophylaxis Trial. N Engl Med 1990, 323:769-775.
25. Hardy WD, Feinberg J, Finkelstein DM, et al.: A controlled trial of trimethoprim-sulfamethoxazole or aerosolized pentamidine for secondary prophylaxis of Pneumocystis carinii pneumonia in patients with the acquired immunodeficiency syndrome. AIDS Clinical Trials Group Protocol 021. N Engl J Med 1992, 327:1842-1848.
26. Bozzette SA, Finkelstein DM, Spector SA, et al.: A randomized trial of three antipneumocystis agents in patients with advanced human immunodeficiency virus infection. N Engl J Med 1995, 332:693-699.
27. Hirschel B, Lazzarin A, Chopard P, et al.: A controlled study of inhaled pentamidine for primary prevention of Pneumocystis carinii pneumonia. N Engl Med 1991, 324:1079-1083.
28. Fischl MA, Dickinson GM, La Voie L: Safety and efficacy of sulfamethoxazole and trimethoprim chemoprophylaxis for Pneumocystis carinii pneumonia in AIDS. JAMA 1988, 259:1185-1189.
29. Ioannidis JP, Cappelleri JC, Skolnik PR, Lau J, Sacks HS: A meta-analysis of the relative efficacy and toxicity of Pneumocystis carinii prophylactic regimens. Arch Intern Med 1996, 156:177-188.
30. Phair J, Munoz A, Detels R, Kaslow R, Rinaldo C, Saah A: The risk of Pneumocystis carinii pneumonia among men infected with human immunodeficiency virus type I. N Engl J Med 1990, 322:161-165.
31. Farizo KM, Buehler JW, Chamberland ME, et al.: Spectrum of disease in persons with human immunodeficiency virus infection in the United States. JAMA 1992, 267:1798-1805.
32. Moore RD, Chaisson RE: Natural history of opportunistic disease in an HIV-infected urban clinical cohort. Ann Intern Med 1996, 124:633-642.
33. Chan ISF, Neaton JD, Saravolatz LD, Crane LR, Osterberger J: Frequencies of opportunistic diseases prior to death among HIV-infected persons. AIDS 1995, 9:1145-1151.
34. Abrams DI, Goldman A, Launer C, et al.: A comparative trial of didanosine and zalcitabine in patients with human immunodeficiency virus infection who are intolerant of or have failed zidovudine therapy. N Engl J Med 1994, 330:657-662.
35. Saravolatz LD, Winslow DL, Collins CJ, et al.: Zidovudine alone or in combination with didanosine or zalcitabine in HIV-infected patients with the acquired immunodeficiency syndrome or fewer than 200 CD4 cells per cubic millimeter. N Engl J Med 1996, 335:1099-1106.
36. 3. 35th Interscience Conference on Antimicrobial Agents and Chemotherapy. San Francisco, September 1995 [abstract LB1].