Harnessing the Power of Real-World Evidence (RWE): A Checklist to Ensure Regulatory-Grade Data Quality

Clin Pharmacol Ther. 2018 Feb;103(2):202-205. doi: 10.1002/cpt.946. Epub 2017 Dec 6.

Abstract

The role of real-world evidence (RWE) in regulatory, drug development, and healthcare decision-making is rapidly expanding. Recent advances have increased the complexity of cancer care and widened the gap between randomized clinical trial (RCT) results and the evidence needed for real-world clinical decisions. Instead of remaining invisible, data from the >95% of cancer patients treated outside of clinical trials can help fill this void.

MeSH terms

  • Antineoplastic Agents / adverse effects
  • Antineoplastic Agents / therapeutic use*
  • Checklist*
  • Data Accuracy*
  • Data Mining / methods*
  • Databases, Factual
  • Drug Development / methods*
  • Drug Discovery / methods*
  • Evidence-Based Medicine / methods*
  • Humans
  • Learning
  • Models, Theoretical
  • Patient Safety
  • Risk Assessment
  • Translational Research, Biomedical / methods*

Substances

  • Antineoplastic Agents