Data Monitoring Committees in Practice

Kerr, David; McBride, Ruth; Shemanski, Lynn
March 2004
Applied Clinical Trials;Mar2004, Vol. 13 Issue 3, p42
Academic Journal
Provides information about data monitoring committees DMC) and clinical trials in the U.S. Role of DMC; Reference to the draft guidance published by the Food and Drug Administration for deciding the need of the DMC in clinical trials; Scenarios under which a DMC might recommend stopping a clinical trial.


Related Articles

  • Clinical drug trials and the role of the nurse. Rath, Louise; Hitchcock, Alison; Oakley, Marion; Graham, Janet // Australian Nursing Journal;May2003, Vol. 10 Issue 10, p1CU 

    Presents an overview of how clinical drug trials are conducted in Australia. Phases of drug trials; Ethical considerations; Role of the research and clinical nurse in the trials. INSET: Common words associated with clinical drug trials.

  • Positive Outcomes Influence the Rate and Time to Publication, but Not the Impact Factor of Publications of Clinical Trial Results Suñé, Pilar; Suñé, Josep Maria; Montoro, J. Bruno // PLoS Clinical Trials;Jan2013, Vol. 8 Issue 1, p1 

    Objectives: Publication bias may affect the validity of evidence based medical decisions. The aim of this study is to assess whether research outcomes affect the dissemination of clinical trial findings, in terms of rate, time to publication, and impact factor of journal publications. ...

  • Are randomized controlled trials controlled? Patient preferences and unblind trials. McPherson, Klim; Britton, Annie R.; Wennberg, John E. // Journal of the Royal Society of Medicine;Dec1997, Vol. 90 Issue 12, p652 

    The most reliable information about treatment effects comes from randomized controlled trials (RCTs). However, the possibility of subtle interactions—for example, between treatment preferences and treatment effects—is generally subordinated in the quest for evidence about main...

  • Precautionary Principles. Corneliussen, Filippa // European Pharmaceutical Executive;May/Jun2006, p58 

    The article focuses on need for the biopharmaceutical industry to examine the oversight framework to regulate biomedical research and development activities in the private sector and to address how these laws and regulations affecting individual companies differ depending on the specific...

  • Trials shock fuels public interest.  // European Pharmaceutical Executive;May/Jun2006, p16 

    The article reports on how the Parexel clinical trial elicited a surge of interested volunteers from the general public. Enter Trials is a web site through which patients can register to participate in clinical trials. It reported that after the Parexel incident, its server hits rose from...

  • Alexza completes enrollment for second Phase III acute agitation trial.  // PharmaWatch: CNS;Dec2008, Vol. 7 Issue 12, p14 

    The article reports that Alexza Pharmaceuticals Inc. has completed enrollment of its second Phase III clinical trial of AZ-004 for the treatment of acute agitation in patients with bipolar disorder. The second AZ-004 Phase III clinical trial was initiated in July 2008 with a target enrollment of...

  • MADNESS IN THEIR METHOD. Wade, Nicholas // New Republic;6/27/83, Vol. 188 Issue 25, p13 

    Focuses on issues concerning fraud in American scientific institutions. Fabrication of a data on new drugs by Joseph H. Cort, a researcher trained at Harvard and Yale Universities; Release of a report of an inquiry by the National Institutes of Health, into a major research fraud at the Harvard...

  • Experts emphasize need for speed in launch of Australian trials. Morgan, Branwen // Nature Medicine;May2011, Vol. 17 Issue 5, p521 

    The article reports on the need for a faster launch in conducting clinical trials of drugs in Australia. It mentions that the number of new trials recorded in the country has decreased to 574 due to higher operating costs and competition from the emerging countries. To address the issue, it...

  • Earlier drug tests on people could be unsafe, critics warn. Wadman, Meredith // Nature Medicine;Feb2006, Vol. 12 Issue 2, p153 

    The article reports that the U.S. Food and Drug Administration announced a significant loosening of the rules that govern experimental drugs to be tested in people. The new rules on drug development will allow scientist to test small doses of experimental drugs in people before full-scale...


Read the Article


Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics