Real-world evidence to guide healthcare policies in oncology
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Marco Donia1, Steen Werner Hansen2 and Inge Marie Svane1
1 National Center for Cancer Immune Therapy (CCIT-DK), Department of Oncology, Herlev, Denmark
2 Head Office, Herlev and Gentofte Hospital, Herlev, Denmark
|Marco Donia,||email:||[email protected]|
|Inge Marie Svane,||email:||[email protected]|
Keywords: real-world evidence; real-world data; clinical trial eligibility
Received: June 02, 2019 Accepted: June 19, 2018 Published: July 16, 2019
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.
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