Independent data-monitoring committee clinical trials

Fundamental healthcare issues may also be involved in the situation of policy-driven therapeutic research. The future investment of society in health may require a large-scale national clinical trial to answer questions relating to the prevention of disease or premature death. This type of clinical trial will not simply relate to one manufacturer s product. As such, it is preferable that the trial is organised on a national level, not necessarily with the exclusion of the company(s) involved. An independent data-monitoring committee (IDMC) should oversee the clinical trial with as much support from the pharmaceutical company(s) as possible. The clinical data collected belongs to the state and should be treated with the same quality standards as any pharmaceutical company sponsored study. 

Weinstein RS, Lopez AM, Joseph BA et al (2014) Telemedicine, telehealth, and mobile health applications that work opportunities and barriers. Am J Med 127 183-187 Wittes J, Schactman M (2014) On independent data monitoring committees in oncology clinical trials. Chin Clin Oncol 3 40... 

Database Manager The database manager functions under the guidance of, but independently from, the Principle Investigator. One model for this function is the data safety and monitoring committees appointed to oversee the progress of clinical trials (6). 

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