NIH-funded research U01 cooperative agreement

Improving clinical trials by using real-world data to reduce hidden biases

Official title: Methods to improve efficiency and robustness of clinical trials using information from real-world data with hidden bias

Funded at Duke University · NIH-10913527 · Data updated 2026-11-12

This study is looking to make clinical trials better by using real-world data to help ensure that new treatments are safe and effective for all kinds of patients, so everyone can benefit from the results.

Quick facts

Grant typeU01 cooperative agreement
Study typeNIH-funded research
Funding institutionDuke University
NIH-funded
Lab location1 site (Durham, United States)
Project startSeptember 1, 2023
Project endAugust 31, 2026
Funding year2024
Award (this year)$821,870
NIH project number5U01FD007934-02
Project IDNIH-10913527 on NIH RePORTER

Who could benefit from this research

Could help

Ideal candidates for this research are patients who are eligible for clinical trials but may have been previously excluded due to the limitations of traditional trial designs.

Less likely to help

Patients with conditions that are not typically included in clinical trials or those who do not meet the eligibility criteria for participation may not benefit from this research.

What this research studies

This research aims to enhance the efficiency and reliability of clinical trials by integrating real-world data (RWD) while addressing hidden biases that may affect trial outcomes. It focuses on developing new analytical methods to assess the validity of RWD when used alongside traditional randomized controlled trials (RCTs). By creating a framework to evaluate the robustness of results, the project seeks to ensure that treatments evaluated in trials are both safe and effective for diverse patient populations. This approach could lead to more inclusive and representative clinical trials, ultimately benefiting patients with various conditions.

Why it matters

Potential benefit: If successful, this research could lead to faster and more accurate evaluations of new treatments, benefiting patients by making effective therapies available sooner.

How similar studies have gone: Other research has shown promise in using real-world data to enhance clinical trial designs, indicating that this approach could lead to significant advancements in the field.

Where this research is happening

  • Duke University
    Durham, United States
    Active

Researchers

  • Principal investigator: Wang, Xiaofei — Duke University
  • Study coordinator: Wang, Xiaofei

Related research

Other NIH-funded projects on the same topics.

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page.
Browse more
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.