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. 2019 Jul 16;10(44):4513-4515.
doi: 10.18632/oncotarget.27077.

Real-world evidence to guide healthcare policies in oncology

Marco Donia  1 , Steen Werner Hansen  2 , Inge Marie Svane  1
Affiliations

Real-world evidence to guide healthcare policies in oncology

Marco Donia et al. Oncotarget. .

Abstract

Randomized controlled clinical trials (RCTs) in oncology enroll patients who meet strict protocol-specified criteria. Many of these criteria overlap across multiple RCTs. A vast proportion of patients with metastatic cancer do not meet such criteria. Hence, patient populations encountered in clinical practice are essentially different from RCT-populations, questioning the representativeness of these trials. A real-world evidence approach, using data from clinical practice, is increasingly employed to complement the information on drug safety and efficacy obtained from traditional clinical trials.

Keywords: clinical trial eligibility; real-world data; real-world evidence.

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Conflict of interest statement

CONFLICTS OF INTEREST MD received honoraria for lectures from Bristol-Myers Squibb, MSD, Roche, Novartis, Sanofi Genzyme, and Astra Zeneca. IMS received honoraria for consultancies and lectures from Novartis, Roche, Merck, Bristol-Myers Squibb, and Incyte.

Figures

Figure 1
Figure 1. Survival of patients diagnosed with metastatic melanoma in the pre-modern era (2012), early-modern era (2014) and modern era (2016).
Kaplan–Meier plot showing the survival of all patients diagnosed with melanoma, not amenable to surgery or other local treatment, in the whole population of Denmark in the calendar years 2012, 2014 and 2016. mo: months.
See this image and copyright information in PMC

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