White Paper – The Real-World Evidence Equation: Finding the Right Late-Stage Study Design
Florian Eichmann, PhD, Principal, Scientific Affairs & Real World Evidence, Late Stage, inVentiv Health Clinical
Stuart McCully, PhD, Vice President, Regulatory Consulting, Late Stage, inVentiv Health Clinical
Although real-world evidence (RWE) has become increasingly popular for its insight into the use and performance of marketed products (i.e., in the real world rather than in controlled clinical trials), many pharmaceutical companies struggle with the basic decision of which study design should be used to address a given research question. The lack of certainty is understandable; the “toolbox” of study types available to researchers is actually quite extensive,
and there are pros and cons to each. In this paper, we present general guidelines to help companies choose a study design that will ensure their Real-World Data (RWD) collection will be fit for their specific purpose.
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