# Overcoming Challenges Posed by Biomarker-Selective Clinical Trials: The Role of a Research Specialist

> **NIH NIH R50** · JOHNS HOPKINS UNIVERSITY · 2024 · $105,619

## Abstract

Project Summary/Abstract
Molecular testing and targeted therapies have revolutionized cancer care resulting in better outcomes for
patients. The number of biomarker-selective clinical trials continues to increase presenting challenges for
cancer centers to adapt processes for efficient identification and enrollment of patients to these clinical trials.
Furthermore, there is a gap in uptake of molecular testing and clinical trial enrollment for minority and
underserved populations. Addressing these challenges plays an important role in ensuring equitable and
effective care for all patients. The Johns Hopkins Sidney Kimmel Comprehensive Cancer Center is an NCI-
designated Comprehensive Cancer Center and one of eight with lead roles in both the NCI Experimental
Therapeutics Clinical Trials Network (ETCTN) and NCI National Clinical Trials Network (NCTN). Biomarker-
selective studies are a major focus of these two networks. In this R50 Project, Dr. Gaillard will focus on
addressing challenges in patient enrollment to biomarker-selective trials. The work will focus on three
approaches: (i) development of a molecular registry to improve process of patient identification and
determination of patient eligibility at the Center level, (ii) facilitate timely referrals to biomarker-selective trials
using an electronic medical record clinical trials alert for eligible patients at the Physician level, and (iii) provide
study-eligible patients with timely education on the role of biomarkers in treatment decision making (Patient
level). The long term goal of this program is to develop a streamlined conduit for identifying, referring and
enrolling patients for personalized medicine trials. Successful development will enhance accrual to NCI-
sponsored clinical trials and be translatable to other cancer centers.

## Key facts

- **NIH application ID:** 10769817
- **Project number:** 5R50CA275932-02
- **Recipient organization:** JOHNS HOPKINS UNIVERSITY
- **Principal Investigator:** Stephanie Gaillard
- **Activity code:** R50 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $105,619
- **Award type:** 5
- **Project period:** 2023-03-01 → 2028-02-29

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10769817

## Citation

> US National Institutes of Health, RePORTER application 10769817, Overcoming Challenges Posed by Biomarker-Selective Clinical Trials: The Role of a Research Specialist (5R50CA275932-02). Retrieved via AI Analytics 2026-06-12 from https://api.ai-analytics.org/grant/nih/10769817. Licensed CC0.

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