Services Clinical Development Late Stage

Real World Data and Real World Evidence

There is still growing excitement among the medical community representatives, regulatory bodies, industry and insurance companies over the increasing availability of Real World Data (RWD) and derived Real World Evidence

There are excellent reasons for this. With the completion of Phase III randomized controlled trials (RCT), evidence of safety, effectiveness, and often the treatment value is only sometimes fully addressed. The strict eligibility criteria used in RCTs narrow the diversity of patients with limited concomitant diseases and medications who are likely to comply with the study requirements. The widely implemented measures, like randomization and stratification, blinding, and intention to treat approaches, necessarily minimizes confounding factors and sources of bias, making differences, if any, easily distinguishable between two interventions. As a consequence of the above facts, the strictly selected subject populations included in RCTs are often not representative of the general population in real-world clinical practice; such ‘real-world’ patients may have poorer performance status and compliance and may include higher proportions of specific age groups.

Real World Evidence

Accelsiors team of experts will help you in selecting the most optimal approach among different types of real-world, observational studies, point out benefits but also limitations of RWE as a complement to clinical trial data, and explain how such evidence can be used to help inform treatment decisions, using examples from recent observational studies.

Real-world evidence is the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of RWD. RWE can be generated by different study designs or analyses, including but not limited to randomized trials, large simple trials, pragmatic trials, and observational studies (prospective and retrospective).

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