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MeSH Review

Clinical Trials Data Monitoring Committees

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Disease relevance of Clinical Trials Data Monitoring Committees

  • RESULTS: On May 31, 2002, after a mean of 5.2 years of follow-up, the data and safety monitoring board recommended stopping the trial of estrogen plus progestin vs placebo because the test statistic for invasive breast cancer exceeded the stopping boundary for this adverse effect and the global index statistic supported risks exceeding benefits [1].

High impact information on Clinical Trials Data Monitoring Committees


Associations of Clinical Trials Data Monitoring Committees with chemical compounds

  • RESULTS: After a mean follow-up of 5.2 years (planned duration, 8.5 years), the data and safety monitoring board recommended terminating the estrogen-plus-progestin trial because the overall risks exceeded the benefits [7].
  • FINDINGS: The iron and folic acid-containing groups of the study were stopped early in November, 2003, on the recommendation of the data and safety monitoring board; mortality in these groups did not differ from placebo and there was low power to detect positive or negative effects by the time enrollment was completed [8].
  • The independent data and safety monitoring board recommended offering open-label emtricitabine based on the interim analysis [9].
  • The amodiaquine group was stopped early by the data and safety monitoring board [10].
  • A scheduled review by the data and safety monitoring board with the use of prespecified stopping boundaries led to a recommendation to stop the triple-nucleoside group and to present the results in the triple-nucleoside group in comparison with pooled data from the efavirenz groups [11].


  1. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results From the Women's Health Initiative randomized controlled trial. Rossouw, J.E., Anderson, G.L., Prentice, R.L., LaCroix, A.Z., Kooperberg, C., Stefanick, M.L., Jackson, R.D., Beresford, S.A., Howard, B.V., Johnson, K.C., Kotchen, J.M., Ockene, J. JAMA (2002) [Pubmed]
  2. Maintaining normal hemoglobin levels with epoetin alfa in mainly nonanemic patients with metastatic breast cancer receiving first-line chemotherapy: a survival study. Leyland-Jones, B., Semiglazov, V., Pawlicki, M., Pienkowski, T., Tjulandin, S., Manikhas, G., Makhson, A., Roth, A., Dodwell, D., Baselga, J., Biakhov, M., Valuckas, K., Voznyi, E., Liu, X., Vercammen, E. J. Clin. Oncol. (2005) [Pubmed]
  3. Management of the relapsed/refractory myeloma patient: strategies incorporating lenalidomide. Richardson, P. Semin. Hematol. (2005) [Pubmed]
  4. A prospective randomized trial of four three-drug regimens in the treatment of disseminated Mycobacterium avium complex disease in AIDS patients: excess mortality associated with high-dose clarithromycin. Terry Beirn Community Programs for Clinical Research on AIDS. Cohn, D.L., Fisher, E.J., Peng, G.T., Hodges, J.S., Chesnut, J., Child, C.C., Franchino, B., Gibert, C.L., El-Sadr, W., Hafner, R., Korvick, J., Ropka, M., Heifets, L., Clotfelter, J., Munroe, D., Horsburgh, C.R. Clin. Infect. Dis. (1999) [Pubmed]
  5. An introductory note to CHMP guidelines: choice of the non-inferiority margin and data monitoring committees. Brown, D., Volkers, P., Day, S. Statistics in medicine. (2006) [Pubmed]
  6. A case report of data monitoring experience: the nocturnal oxygen therapy trial. DeMets, D.L., Williams, G.W., Brown, B.W. Controlled clinical trials. (1982) [Pubmed]
  7. Estrogen plus progestin and the risk of coronary heart disease. Manson, J.E., Hsia, J., Johnson, K.C., Rossouw, J.E., Assaf, A.R., Lasser, N.L., Trevisan, M., Black, H.R., Heckbert, S.R., Detrano, R., Strickland, O.L., Wong, N.D., Crouse, J.R., Stein, E., Cushman, M. N. Engl. J. Med. (2003) [Pubmed]
  8. Effect of routine prophylactic supplementation with iron and folic acid on preschool child mortality in southern Nepal: community-based, cluster-randomised, placebo-controlled trial. Tielsch, J.M., Khatry, S.K., Stoltzfus, R.J., Katz, J., LeClerq, S.C., Adhikari, R., Mullany, L.C., Shresta, S., Black, R.E. Lancet (2006) [Pubmed]
  9. Efficacy and safety of emtricitabine vs stavudine in combination therapy in antiretroviral-naive patients: a randomized trial. Saag, M.S., Cahn, P., Raffi, F., Wolff, M., Pearce, D., Molina, J.M., Powderly, W., Shaw, A.L., Mondou, E., Hinkle, J., Borroto-Esoda, K., Quinn, J.B., Barry, D.W., Rousseau, F. JAMA (2004) [Pubmed]
  10. Amodiaquine alone, amodiaquine+sulfadoxine-pyrimethamine, amodiaquine+artesunate, and artemether-lumefantrine for outpatient treatment of malaria in Tanzanian children: a four-arm randomised effectiveness trial. Mutabingwa, T.K., Anthony, D., Heller, A., Hallett, R., Ahmed, J., Drakeley, C., Greenwood, B.M., Whitty, C.J. Lancet (2005) [Pubmed]
  11. Triple-nucleoside regimens versus efavirenz-containing regimens for the initial treatment of HIV-1 infection. Gulick, R.M., Ribaudo, H.J., Shikuma, C.M., Lustgarten, S., Squires, K.E., Meyer, W.A., Acosta, E.P., Schackman, B.R., Pilcher, C.D., Murphy, R.L., Maher, W.E., Witt, M.D., Reichman, R.C., Snyder, S., Klingman, K.L., Kuritzkes, D.R. N. Engl. J. Med. (2004) [Pubmed]
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