Trial Enrollment Diversity Dashboard for Leukemia

(TEDD Trial)

Overseen By Erin Gallagher

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Other diagnoses, Not at study sites

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

12 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What safety data exists for the treatment evaluated in the Trial Enrollment Diversity Dashboard for Leukemia?

The research articles do not provide specific safety data for the treatment evaluated in the Trial Enrollment Diversity Dashboard for Leukemia. ^{1 2 3 4 5}

What is the purpose of this trial?

The goal of this study is to test the feasibility of a data visualization tool called the Trial Enrollment Diversity Dashboard (TEDD) to ensure participant diversity in acute leukemia trial enrollment.

Research Team

Andrew Hantel, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

This trial is for individuals involved in enrolling participants for acute leukemia trials, specifically aiming to improve diversity among those enrolled. The exact eligibility criteria are not provided.

Inclusion Criteria

* Physician, nurse practitioner, or physician assistant

-≥10% clinical effort (or one ½ day of clinic per week for those working \<1 FTE)

* Treats adult patients with leukemia or related diseases at the study sites

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

TEDD Intervention

Medical professionals use the TEDD tool and provide feedback on its usability and effectiveness

12 months

Continuous access and quarterly feedback

Follow-up

Participants are monitored for feedback and effectiveness of the TEDD tool after the intervention period

2-4 weeks

Treatment Details

Interventions

• Trial Enrollment Diversity Dashboard

Trial Overview The study is testing a data visualization tool called the Trial Enrollment Diversity Dashboard (TEDD) designed to help achieve diverse participant enrollment in acute leukemia clinical trials.

Participant Groups

Group I: TEDD Intervention Experimental Treatment 1 Intervention

12 medical professional participants will complete the following: * Baseline survey. * Usage and access of the TEDD intervention over a 12-month period. * Follow up surveys at the end of each quarter.

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

American Society of Clinical Oncology

Collaborator

Trials

40

Recruited

148,000+

Findings from Research

Adverse event (AE) reporting in pediatric acute myeloid leukemia trials often underestimates the actual rates, with sensitivity for many AEs being less than 50%, indicating a need for improved reporting methods.

Using external electronic data sources, like Pediatric Health Information System (PHIS) billing and microbiology data, significantly enhances the accuracy of AE detection, particularly for specific toxicities such as viridans group streptococcal bacteremia, which showed high sensitivity and positive predictive value.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy of Adverse Event Ascertainment in Clinical Trials for Pediatric Acute Myeloid Leukemia. Miller, TP., Li, Y., Kavcic, M., et al.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Data visualization explorer: A tool for participant representation in pivotal trials of FDA-approved medicinal products. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Racial and ethnic enrollment disparities and demographic reporting requirements in acute leukemia clinical trials. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Accuracy of Adverse Event Ascertainment in Clinical Trials for Pediatric Acute Myeloid Leukemia. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

A Review of the Evolving Landscape of Inclusive Research and Improved Clinical Trial Access. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

FDA Analysis of Ineligibility for Acute Myeloid Leukemia Clinical Trials by Race and Ethnicity. [2023]