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Clinical research using real-world data: A narrative review.

Yuya Kimura1, Taisuke Jo2, Hiroki Matsui3

  • 1Department of Clinical Epidemiology and Health Economics, School of Public Health, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan; Clinical Research Center, NHO Tokyo National Hospital, 3-1-1 Takeoka, Kiyose-shi, Tokyo, 204-8585, Japan.

Respiratory Investigation
|August 25, 2024
PubMed
Summary

Real-world data (RWD) studies, particularly those using administrative claims databases, offer valuable alternatives when randomized controlled trials (RCTs) are not feasible. Understanding the characteristics of different RWD sources is crucial for accurate research interpretation.

Keywords:
Claims databaseDiagnosis procedure combination databaseNational database of health insurance claims and specific health checkups of JapanRandomized controlled trialReal-world data

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Area of Science:

  • Health Services Research
  • Biostatistics
  • Epidemiology

Background:

  • Randomized controlled trials (RCTs) and real-world data (RWD) studies have complementary strengths and weaknesses.
  • RWD studies serve as a crucial alternative when RCTs are not feasible.
  • Administrative claims databases are a significant source of RWD.

Purpose of the Study:

  • To review various types of RWD studies, with a focus on administrative claims databases.
  • To highlight the importance of selecting appropriate RWD sources for specific research questions.
  • To emphasize the need for readers to understand the characteristics of RWD databases for proper interpretation of findings.

Main Methods:

  • Narrative review of studies utilizing real-world data.
  • Examination of specific types of administrative claims databases in Japan, including Diagnosis Procedure Combination (DPC) databases, commercial databases (JDMC, DeSC), and the National Database of Health Insurance Claims and Specific Health Checkups (NDB).

Main Results:

  • Different administrative claims databases possess unique characteristics regarding populations, patient settings, variables, and accessibility.
  • The selection of the most suitable database is critical for addressing specific research questions effectively.
  • Awareness of database characteristics is essential for understanding the context and limitations of research findings.

Conclusions:

  • RWD studies, especially those using administrative claims data, are valuable complements to RCTs.
  • Researchers must carefully choose RWD sources based on their research objectives.
  • A thorough understanding of RWD database properties enhances the validity and interpretability of study results.