Blausen Medical
Blausen Medical

Blausen Medical

Medically accurate and informative 3D animations


Real World Evidence

"Randomized controlled clinical trials (or RCTs) are considered the gold standard for assessing the efficacy of a therapy (or intervention). The patients entering these trials have a set of clinical characteristics that are relatively homogeneous and therefore avoid factors that may influence the outcome of a trial. This is also one of the limitations of RCTs – the results would not necessarily be generalizable to a broader population with other characteristics, such as their age, race, co-morbidities or disease stage. RCTs are also short in duration. In the real world, “efficacy” is referred to as “effectiveness.” This means that the therapy works in the controlled setting of an RCT and in the real world where many factors may influence the effect of the therapy on patients’ outcomes and for a longer period of time. Approval of a therapy by regulatory authorities is contingent on RCT data. Payers and reimbursement authorities may include real world findings in addition to those from RCTs when deciding on treatments to reimburse. ¬Real-world evidence is complementary to and not intended to replace RCTs. It has multiple sources: • Prospective sources, such as registries. Although there is no placebo or comparator arm, registries accumulate valuable information. • Other sources of are retrospective in nature, such as insurance databases. Some of these real-world data sources are observational data sources as we are observing the effects of therapies outside an RCT. They can be forward-looking (cohort studies) or backward-looking (case-control studies) or at a static point in time (cross-sectional studies), like a survey. RWE data sources do have limitations and biases given that patients are not randomized. Complex statistical analyses are required to minimize these biases and confounding factors and thus strengthen the validity and utility of RWE. Here are few examples of real-world data sources in MS. These sources have helped to advance our understanding of the natural history of MS, factors that influence the course of the disease and the long-term effectiveness and safety of therapies."

Duration: 02:41
Licence: CC - Attribution
Original Language: English
Published: 8/9/2019
Diseases and Conditions: Multiple Sclerosis
Format: 3D Animation

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