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Safeguards in Studies: the Role of Data Monitoring Committees in Clinical Trials

机译:Safeguards in Studies: the Role of Data Monitoring Committees in Clinical Trials

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摘要

A randomi/ed clinical trial, il properly designed and carried out, provides the most rigorous assessment ol an intervention, whether a drug, vaccine, medical device, or behavior modilication. I he simplicity ol the randomi/ed trial is its strength. With randomization ol study participants to treatment and control groups, unknown lactors that might influence response to treatment are balanced on average. With a sufficiently large sample si/c, random errors for comparing treatments are reduced. With blinding of treatments and excellent lollowup. biases associated with outcome assessment are reduced.

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