Now showing items 1-3 of 3

    • Data monitoring and interim analyses in the pharmaceutical industry: ethical and logistical considerations. 

      Rockhold, FW; Enas, GG (Stat Med, 1993-03)
      The characteristics of data monitoring and the need for the use of data monitoring committees in clinical trials sponsored by the pharmaceutical industry differ from those of trials sponsored by government. Data monitoring ...
    • Issues in regulatory guidelines for data monitoring committees. 

      DeMets, David; Califf, Robert; Dixon, Dennis; Ellenberg, Susan; Fleming, Thomas; Held, Peter; Julian, Desmond; ... (19 authors) (Clin Trials, 2004)
      As clinical trials have emerged as the major research method for evaluating new interventions, the process for monitoring intervention safety and benefit has also evolved. The Data Monitoring Committee (DMC) has become the ...
    • Liability issues for data monitoring committee members. 

      DeMets, David L; Fleming, Thomas R; Rockhold, Frank; Massie, Barry; Merchant, Thomas; Meisel, Alan; Mishkin, Barbara; ... (10 authors) (Clin Trials, 2004)
      In randomized clinical trials, a data monitoring committee (DMC) is often appointed to review interim data to determine whether there is early convincing evidence of intervention benefit, lack of benefit or harm to study ...