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Review
. 2021 Aug;133(15-16):840-846.
doi: 10.1007/s00508-021-01851-w. Epub 2021 Apr 9.

Real-world evidence and product development: Opportunities, challenges and risk mitigation

Poobalan Naidoo  1 , Célia Bouharati  2 , Virendra Rambiritch  3 , Nadina Jose  4 , Sumanth Karamchand  5 , Robert Chilton  6 , Rory Leisegang  7   8
Affiliations
Review

Real-world evidence and product development: Opportunities, challenges and risk mitigation

Poobalan Naidoo et al. Wien Klin Wochenschr. 2021 Aug.

Abstract

Real-world evidence (RWE) is derived from real-world data (RWD) sources including electronic health records, claims data, registries (disease, product) and pragmatic clinical trials. The importance of RWE derived from RWD has been once again demonstrated during the coronavirus disease 2019 (COVID-19) pandemic, as it can improve patient care by complementing information obtained from traditional clinical trial programs. Additionally, RWE can generate insights into disease mechanisms, epidemiology, patient flows in and out of healthcare systems, and drivers and barriers to optimal clinical care in real-world settings. Identifying unmet medical needs is crucial as it often can inform which investigational new drugs enter clinical trial testing, and RWE studies from hospital settings have contributed substantial progress here. RWE can also optimize the design of clinical studies, inform benefit risk assessments and use networks of pragmatic studies to help with clinical trial feasibilities and eventual trial initiation. The challenges of RWD include data quality, reproducibility and accuracy which may affect validity. RWD and RWE must be fit for purpose and one must be cognizant of inherent biases.

Keywords: Cost Reduction; Product lifecycle; Real-world data; Routine clinical practice; Systematic error.

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Conflict of interest statement

P. Naidoo, C. Bouharati, V. Rambiritch, N. Jose, S. Karamchand, R. Chilton, and R. Leisegang declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
The value of real-world evidence for product life cycle management
See this image and copyright information in PMC

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