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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the Trial Enrollment Diversity Dashboard (TEDD) to determine its effectiveness in increasing diversity in leukemia trials. Medical professionals use this tool to track and enhance participant variety in these studies. Adults diagnosed with leukemia, lymphoma, myeloma, or related diseases and receiving treatment at specific study sites may qualify for this trial. As an unphased trial, it offers a unique opportunity to contribute to improving diversity in clinical research, potentially enhancing treatment outcomes for a broader range of patients.

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 prior data suggests that the Trial Enrollment Diversity Dashboard is safe for use in ensuring participant diversity?

In a previous study, researchers created the Trial Enrollment Diversity Dashboard (TEDD) to increase diversity in leukemia trial participation. TEDD is a software tool that visually displays data and involves no medications or medical procedures, eliminating direct safety concerns for users. TEDD assists researchers and medical professionals in ensuring diverse participation in clinical trials. As a tool rather than a treatment, TEDD lacks the usual risks associated with medical procedures, assuring participants that using TEDD poses no health risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Trial Enrollment Diversity Dashboard (TEDD) intervention because it aims to revolutionize how we approach clinical trial diversity, particularly for leukemia. Unlike traditional methods that often struggle to ensure diverse participation, TEDD offers a structured approach with access and usage monitoring over a 12-month period. This could lead to more inclusive and representative trial results, ultimately improving treatment options for everyone. By providing consistent follow-up and feedback, TEDD has the potential to identify and address barriers to participation, paving the way for more equitable healthcare advancements.

What evidence suggests that the Trial Enrollment Diversity Dashboard is effective for ensuring participant diversity in leukemia trials?

The Trial Enrollment Diversity Dashboard (TEDD) is a tool designed to increase diversity in cancer trials, including those for acute leukemia. Research has shown that TEDD links trial sign-up information with electronic health records, ensuring a wider variety of participants. Tested at the Dana-Farber Cancer Institute, this tool showed promise in accurately including a diverse group of patients. Although TEDD does not treat leukemia, it aims to make trials more inclusive, potentially improving the effectiveness of future treatments by considering a broader range of patients. Initial findings suggest it could play a key role in ensuring fair trial access and representation. ^{1 2 3 4 5}

Who Is on the Research Team?

Andrew Hantel, MD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06795139

Pilot of a Trial Enrollment Diversity Dashboard (TEDD) This study is about testing a tool called the Trial Enrollment Diversity Dashboard (TEDD) to see if it can help increase diversity in cancer clinical trials, ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39353157/

The Trial Enrollment Diversity Dashboard for Acute Leukemia ... We created a visual dashboard linking leukemia clinical trial registration and EHR data at the Dana-Farber Cancer Institute.

3. ascopubs.org ascopubs.org/doi/pdf/10.1200/OP.24.00319

The Trial Enrollment Diversity Dashboard for Acute Leukemia ... The objective of this portion of the intervention was to construct and refine the Trial Enrollment Diversity Dash- board (TEDD), a visual data interface for ...

4. ovid.com ovid.com/journals/jcopr/fulltext/10.1200/op.24.00319~the-trial-enrollment-diversity-dashboard-for-acute-leukemia

The Trial Enrollment Diversity Dashboard for Acute Leukemia ... We created a visual dashboard linking leukemia clinical trial registration and EHR data at the Dana-Farber Cancer Institute. Accuracy of a patient inclusion and ...

5. trial.medpath.com trial.medpath.com/clinical-trial/0435fd4fced2f3bb/nct06795139-trial-enrollment-diversity-dashboard

Pilot of a Trial Enrollment Diversity Dashboard | MedPath This study is about testing a tool called the Trial Enrollment Diversity Dashboard (TEDD) to see if it can help increase diversity in cancer clinical trials ...