Dr. Chitra Lele, Chief Scientific Officer, Sciformix

Real World Evidence: An Emerging Phenomenon

Dr. Chitra Lele

[This is the first in a three part series that discusses and to a certain extent demystifies the phenomenon that is Real World Evidence (RWE). This post focuses on Real World Data (RWD) and how it can effectively supplement clinical trial evidence when the latter is available from limited data.]

The past few years have seen increasing focus on data obtained from the real world as an effective and important supplement to clinical trial data. The need to confirm the effectiveness of products after they are on the market has become more evident, particularly with respect to the influence of effectiveness on practice, prescription and reimbursement. Real World Evidence (RWE) is based on patient treatment data from approved medical interventions, including clinical, humanistic and economic data, and is used to make decisions about treatment options, healthcare provider acceptance and as a guide for future research and development.

The US FDA has defined RWD and RWE. RWD is the data collected from sources such as pragmatic and observational studies, retrospective database searches, case report form reviews, patient or disease registries, electronic health records and payers’ databases. These data are being increasingly obtained from electronic tracking systems used in healthcare to capture patient experiences during care. RWE is the evidence derived from the aggregation and analysis of RWD.

RWD enables judgements to be made on the product’s long term safety and effectiveness. Product differentiation can be established through real world studies that provide a greater understanding of clinical practice patterns and epidemiology of the disease. The information obtained from RWD is then useful to a multitude of stakeholders that include innovators, manufacturers, practitioners, healthcare providers and most importantly patients. This gives practitioners and healthcare providers more tools to improve the quality of patient care and identify patient sub-groups that may benefit from specific treatments, whereas manufacturers and innovators are able to strategize marketing plans, identify target audiences and build relationship strategies for the target audiences.

Real World Data is a powerful tool that can assist the healthcare industry in patient-centric care by increasing the speed at which drugs and devices come to market whilst also improving patient outcomes.
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