# Prospective evaluation of barriers to patient referral and enrollment in emerging cellular therapy trials: determining methods and structure to improve equity in future trial design

> **NIH NIH U01** · SEATTLE CHILDREN'S HOSPITAL · 2020 · $159,801

## Abstract

Project Summary & Abstract
The Patient Advocacy Committee of the Consortium for Pediatric Cellular Immunotherapy supported by
the NCATS U01 to “Accelerate cellular immunotherapy for treatment of life-threatening disorders” has
been focused on retrospectively examining whether or not there is equitable enrollment by underrepresented
populations such as lower socioeconomic and minority populations in cellular therapy trials across the member
institutions. Concern exists that unique, identifiable patient cohorts may face barriers to recruitment and/or
enrollment on these trials. For instance, referring clinicians may be limiting patients’ access to the consortium
institution trials due to inadequate insurance status, English language proficiency, geography, family
characteristics or other factors. Thus, it is important to understand the referring clinician perspective to
determine how these clinicians decide whom to refer and therefore whether there are limitations
impacting referral and study enrollment patterns. Furthermore, to date, the Committee has focused on patients
and families that have enrolled on cellular therapy trials. We understand, however, that it is vital to
prospectively analyze the perspectives and experiences of those families unable to enroll and those
who encounter barriers to participation. Further elucidating clinician- and family-level factors that may
influence referral patterns can help with future approaches to clinical trials for emerging therapies to improve
equity to study participation. Therefore, through this supplemental bioethics application, we aim to: 1)
understand how clinicians make patient referral decisions for specialized pediatric immunotherapy trials and
determine how these decisions might contribute to inequitable access; and 2) identify the key barriers to
recruitment and enrollment in cellular therapy trials, as identified by families. These data will inform policies to
ensure that resources and systems are in place to optimize equitable participation through robust trial design
and that recruitment and enrollment for novel emerging therapies for pediatric diseases are equitably
accessible. Finally, this work will generate pilot data for a subsequent R01 application that proposes to
longitudinally examine the family experience and clinician referral patterns across novel pediatric emerging
therapies, including cellular and gene therapies, across multiple consortia.

## Key facts

- **NIH application ID:** 10130404
- **Project number:** 3U01TR002487-03S1
- **Recipient organization:** SEATTLE CHILDREN'S HOSPITAL
- **Principal Investigator:** Anurag Agrawal
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $159,801
- **Award type:** 3
- **Project period:** 2018-08-01 → 2023-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10130404

## Citation

> US National Institutes of Health, RePORTER application 10130404, Prospective evaluation of barriers to patient referral and enrollment in emerging cellular therapy trials: determining methods and structure to improve equity in future trial design (3U01TR002487-03S1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10130404. Licensed CC0.

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