Monitoring clinical trials: Issues and controversies regarding confidentiality

Statistics in Medicine

Volumn 21, Issue 19, 2002, Pages 2843-2851

  Fleming, Thomas R ^a   Ellenberg, Susan ^b   DeMets, David L ^c  

^a UNIVERSITY OF WASHINGTON   (United States)

^b CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^c UNIVERSITY OF WISCONSIN SCHOOL OF MEDICINE AND PUBLIC HEALTH   (United States)

Author keywords

Blinding; Confidentiality; Data monitoring committee; Interim data

Indexed keywords

DIDANOSINE; GANCICLOVIR; ZALCITABINE; ZIDOVUDINE;

ARTICLE; CLINICAL TRIAL; CONFIDENTIALITY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CYTOMEGALOVIRUS INFECTION; DATA ANALYSIS; DRUG EFFICACY; DRUG SAFETY; HEALTH CARE ORGANIZATION; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; MEDICAL ETHICS; MONITORING; OUTCOMES RESEARCH; PHASE 3 CLINICAL TRIAL; PUBLICATION; RELIABILITY; RISK BENEFIT ANALYSIS; STATISTICS;

ACQUIRED IMMUNODEFICIENCY SYNDROME; CLINICAL TRIALS DATA MONITORING COMMITTEES; CLINICAL TRIALS, PHASE III; CONFIDENTIALITY; CYTOMEGALOVIRUS INFECTIONS; DATA INTERPRETATION, STATISTICAL; HUMANS; PATIENT COMPLIANCE; PATIENT SELECTION; RECTAL NEOPLASMS; TREATMENT OUTCOME;

EID: 0037108141     PISSN: 02776715     EISSN: None     Source Type: Journal    
DOI: 10.1002/sim.1288     Document Type: Article

References (15)

1. Heart Special Project Committee. Organization, review and administration of cooperative studies (Greenberg Report): a report for the Heart Special Project Committee to the National Advisory Council, May 1967. Controlled Clinical Trials 1988; 9:137-148.
2. Coronary Drug Project Research Group. Practical aspects of decision making in clinical trials: the Coronary Drug Project as a case study. Controlled Clinical Trials 1981; 2:363-376.
3. Fleming TR, DeMets DL. Monitoring of clinical trials: Issues and recommendations. Controlled Clinical Trials 1993; 14:183-197.
4. DeMets DL, Ellenberg SS, Fleming TR, Childress JF, Mayer KH, Pollard RB, Rahal JJ, Walters L, O'Fallon J, Whitley-Williams P, Straus S, Sande M, Whitley RJ. The data and safety monitoring board and acquired immune deficiency syndrome (AIDS) clinical trials. Controlled Clinical Trials 1995; 16:408-421.
5. Abrams DI, Goldman Al, Launer C, Korvick JA, Neaton JD, Crane LR, Grodesky M, Wakefield S, Muth K, Kornegay S, Cohn DL, Harris A, Luskin-Hawk R, Markowitz N, Sampson JH, Thompson M, Deyton L, for The Terry Beirn Community Programs for Clinical Research on AIDS. A comparative trial of didanosine or zalcitabine after treatment with zidovudine in patients with human immunodeficiency virus infection. New England Journal of Medicine 1994; 330:657-662.
6. Green SJ, Fleming TR, O'Fallon JR. Policies for study monitoring and interim reporting of results. Journal of Clinical Oncology 1987; 5:1477-1484.
7. Rider WD, Palmer JA, Mahoney LJ, Robertson CT. Preoperative irradiation in operable cancer of the rectum: Report of the Toronto trial. Canadian Journal of Suryery 1977; 20:335-338.
8. Medical Research Council Working Party. The evaluation of low-dose pre-operative X-ray therapy in the management of operable rectal cancer: results of a randomly controlled trial. British Journal of Surgery 1984; 71:21-25.
9. Meinert CL. Masked monitoring in clinical trials - Blind stupidity? New, England Journal of Medicine 1998; 338(19):1381-1382.
10. Echt DS, Liebson PR, Mitchell LB, Peters RW, Obias-Manno D, Barker AH, Arensberg D, Baker A, Friedman L,Greene L, Huther ML, Richardson DW, and the CAST investigators. Mortality and morbidity in patients receiving encainide, flecainide, or placebo. The Cardiac Arrhythmia Suppression Trial. New England Journal of Medicine 1991; 324:781-788.
11. Brosgart C, Louis TA, Hillman D, Craig C, Alston B, Fisher E, Abrams DI, Luskin-Hawk R, Sampson J. A randomized, placebo-controlled trial of the safety and efficacy of oral ganciclovir for prophylaxis of cytomegalovirus disease in HIV-infected individuals. AIDS 1998; 12:269-277.
12. Spector SA, McKinley GF, Lalezari JP, Samo T, Andruczk R, Follansbee S, Sparti PD, Havlir DV, Simpson G, Buhles W, Wong R, Stempien MJ, for The Roche Cooperative Oral Ganciclovir Study Group. Oral ganciclovir for the prevention of cytomegalovirus disease in persons with AIDS. New England Journal of'Medicine 1996; 334(23):1491-1497.
13. Dixon DO, Lagakos SW. Should data and safety monitoring boards share confidential interim data? Controlled Clinical Trials 2000; 21(1):54-55.
14. Saravolatz LD, Winslow DL, Collins G, Hodges JS, Pettinelli C, Stein DS, Markowitz N, Reves R, Loveless MO, Crane L, Thompson M, Abrams D, for Investigators for the Terry Beirn Community Programs for Clinical Research on AIDS. 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. New England Journal of Medicine 1996; 335:1099-1106.
15. 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.