Getting To Reimbursement Faster: Combining Randomised, Pragmatic, and Observational Clinical Trial Data.
نویسنده
چکیده
The current tendency is to provide post-approval evidence from separate, often larger and less well controlled trials. Typical examples of these are pragmatic trials (randomisation, little/no control), purely prospective observational trials (no randomisation, no control) and use of historic controls. #3 New study design: Mixed RCT (cont.) In a Mixed RCT patients would be selected and randomised to one of three trial ‘arms’: • Trial Arm #1: Randomised Controlled Trial (RCT) • Trial Arm #2: Pragmatic Trial (PT) • Trial Arm #3: Observational Trial (OT)
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ورودعنوان ژورنال:
- Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research
دوره 17 7 شماره
صفحات -
تاریخ انتشار 2014