A simple framework for assessing and reporting data availability in an ongoing clinical trial is described. Protocol requirements, visit schedules and data availability are combined into a simple report to track the progress of a study.
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References
1.
1. Mellors JW, Munoz A, Giorgi JV et al. Plasma viral load and CD4 lymphocytes as prognostic markers of HIV-1 infection. Ann Intern Med1997; 126: 946–954.
2.
2. O'Brien WA, Hartigan PM, Martin D et al. Changes in plasma HIV-1 and CD4 lymphocyte counts and the risk of progression to AIDS. N Engl J Med1996; 334: 426–431.
3.
3. Detels R, Munoz A, McFarlane G et al. Effectiveness of potent antiretroviral therapy on time to AIDS and death in men with known HIV infection duration. JAMA1998; 280: 1497–1503.
4.
4. Mildvan D, Landay A, DeGruttola V, Machado SG, Kagan J.An approach to the validation of markers for use in AIDS clinical trials. Clin Infect Dis1997; 24: 764–774.
5.
5. Murray JS, Elashoff MR, Iacono-Connors LC, Cvetkovich TA, Struble KA. The use of plasma HIV RNA as a study endpoint in efficacy trials of antiretroviral drugs. AIDS1999; 13: 797–804.
6.
6. Gilbert PB, Ribaudo HJ, Greenberg L et al. Considerations in choosing a primary endpoint that measures durability of virologic suppression in an antiretroviral trial. AIDS2000; 14: 1961–1972.
7.
7. Guidance for Industry. Antiretroviral Drugs Using Plasma HIV RNA Measurements – Clinical Considerations for Accelerated and Traditional Approval. FDA Center for Drug Evaluation and Research, 2002. http://www.fda.gov/cder/guidance/index.htm. (Last accessed 28 January 2004).
9. Weiss RB, Vogelzang NJ, Peterson BA et al.A successful system of scientific data audits for clinical trials: A report from the cancer and leukemia group B. JAMA1993; 270: 459–464.
