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NIH Collaboratory
Living Textbook of
Pragmatic Clinical Trials

COVID-19 Resources

Access the latest information on COVID-19 for clinical researchers
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Rethinking Clinical Trials

A Living Textbook of Pragmatic Clinical Trials

  • Design
    • What is a Pragmatic Clinical Trial?
    • Decentralized Pragmatic Clinical Trials
    • Developing a Compelling Grant Application
    • Experimental Designs and Randomization Schemes
    • Endpoints and Outcomes
    • Analysis Plan
    • Using Electronic Health Record Data
    • Building Partnerships and Teams to Ensure a Successful Trial
    • Intervention Delivery and Complexity
    • Patient Engagement
  • Data, Tools & Conduct
    • Assessing Feasibility
    • Acquiring Real-World Data
    • Assessing Fitness-for-Use of Real-World Data
    • Study Startup
    • Participant Recruitment
    • Monitoring Intervention Fidelity and Adaptations
    • Patient-Reported Outcomes
    • Clinical Decision Support
    • Mobile Health
    • Electronic Health Records–Based Phenotyping
    • Navigating the Unknown
  • Dissemination & Implementation
    • Data Sharing and Embedded Research
    • Dissemination Approaches for Different Audiences
    • Implementation
    • End-of-Trial Decision-Making
  • Ethics & Regulatory
    • Privacy Considerations
    • Identifying Those Engaged in Research
    • Collateral Findings
    • Consent, Disclosure, and Non-Disclosure
    • Data and Safety Monitoring
    • Ethical Considerations of Data Sharing in Pragmatic Clinical Trials
    • Ethics for AI and ML
    • IRB Responsibilities and Procedures

Introduction

CHAPTER SECTIONS

Assessing Fitness for Use of Real-World Data Sources


Section 1

Introduction

Expand Contributors

Keith A. Marsolo, PhD
Rachel Richesson, MS, PhD, MPH
Bradley G Hammill, DrPH, MA
Emily O’Brien, PhD
Michelle Smerek, BS
Lesley Curtis, PhD

Contributing Editor
Karen Staman, MS

Many of the real-world data sources used in clinical research are considered "secondary" sources, because the data were collected for a purpose other than the research project for which they are being used (eg, billing or clinical care). This contrasts with primary data sources, where the data are captured specifically for clinical care, billing, or a specific prospective study. (See the Acquiring Real-World Data chapter of the Living Textbook for more information about the different types of real-world data.) Consequently, before a real-world data source can be used in an analysis, one must understand its characteristics and limitations to determine whether it can be appropriately used to answer the question at hand. A given dataset may be well suited to answer a research question for a specific patient population over a certain time period, but not suitable for a different population or time frame. For this reason, data must be assessed to determine whether they are fit for their intended use or purpose prior to their use in research settings. This chapter describes several approaches that can be used to facilitate such assessments.

SECTIONS

CHAPTER SECTIONS

sections

  1. Introduction
  2. Defining Fitness for Use
  3. Evaluating Fitness for Use
  4. Data Quality Measures
  5. Use of Medicare Data in PCTs
  6. Data Source Accuracy: Case Study from TRANSLATE-ACS
  7. Data Provenance
  8. Operationalizing Fitness-for-Use Assessments

Resources

Grand Rounds

Advances at the Intersection of Digital Health, Electronic Health Records, and Pragmatic Clinical Trials: Keys to Success in the Evolving EHR Environment; NIH Collaboratory Grand Rounds; June 26, 2020

Real-World Evidence for Drug Effectiveness Evaluation: Addressing the Credibility Gap; NIH Collaboratory Grand Rounds; October 25, 2019

Research at Scale – Exploring What is Possible with High-Quality Real-World Data. Examples from Flatiron Health; NIH Collaboratory Grand Rounds; June 15, 2018

Podcasts

Advances at the Intersection of Digital Health, Electronic Health Records, and Pragmatic Clinical Trials: Real World Evidence: Contemporary Experience and Future Directions; NIH Collaboratory Grand Rounds Podcast; May 8, 2020

Research at Scale – Exploring What is Possible with High-Quality Real-World Data. Examples from Flatiron Health; NIH Collaboratory Grand Rounds Podcast; June 22, 2018


Version History

August 26, 2022: Minor revisions as part of annual update (changes made by K. Staman).

Published August 25, 2020

current section :

Introduction

  1. Introduction
  2. Defining Fitness for Use
  3. Evaluating Fitness for Use
  4. Data Quality Measures
  5. Use of Medicare Data in PCTs
  6. Data Source Accuracy: Case Study from TRANSLATE-ACS
  7. Data Provenance
  8. Operationalizing Fitness-for-Use Assessments

Citation:

Marsolo KA, Richesson RL, Hammill BG, et al. Assessing Fitness for Use of Real-World Data Sources: Introduction. In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Bethesda, MD: NIH Pragmatic Trials Collaboratory. Available at: https://rethinkingclinicaltrials.org/chapters/conduct/assessing-fitness-for-use-of-real-world-data-sources/introduction/. Updated December 3, 2025. DOI: 10.28929/183.

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