Diversity, Inclusion, and Equity in Clinical Research: Guidance Toolkit & User Guide: Study Design, Conduct and Implementation

Toolkit & Users Guide

Developed on: August 2020

Developed by: MRCT Center Diversity Workgroup

Study Design Logic Model (PDF)
Study Design Logic Model (Editable PDF)
Study Design Key Performance Indicators (PDF)
Screen Failure Tracking Log (PDF)
Screen Failure Tracking Log (Word Doc)
Eligibility and Enrollment Log (PDF)
Eligibility and Enrollment Log (Word Doc)
Site Selection Logic Model (PDF)
Site Selection Logic Model (Editable PDF)
Site Selection Key Performance Indicators (PDF)
Feasibility Decision Tree (PDF)
Feasibility Questionnaire Modification Checklist (PDF)
Recruitment Strategy Document Template (PDF)
Recruitment Strategy Document Template (Word Doc)
Recruitment Strategy Logic Model (PDF)
Recruitment Strategy Logic Model (Editable PDF)
Recruitment Strategy Key Performance Indicators (PDF)
Recruitment Contingency Action Plan (PDF)
Participant Time Commitment Model (PDF)
Recruitment, Conduct, and Retention Logic Model (PDF)
Recruitment, Conduct, and Retention Logic Model (Editable PDF)
Recruitment, Conduct, and Retention Key Performance Indicators (PDF)

Related Resources

See related Resources, maintained on our project specific website:
Diversity, Inclusion, and Equity in Clinical Research

Introduction 

Participant and Community Engagement 

Participant Awareness, Knowledge, and Access

Workforce and Diversity: Training and Development 

Data Variables and Collection 

Stakeholder Commitments and the Future 

Institutions as an ethical locus of research prioritization

Publication

Released on: April 6, 2017

Published in: Journal of Medical Ethics

Ensuring that clinical trials, once launched, successfully complete and generate useful knowledge is an important and indeed ethically imperative goal, given the risks and burdens borne by research participants. Since there are insufficient willing research participants to power all the trials that are currently undertaken,1 addressing underenrolment will require prioritisation decisions that reduce the number of trials competing for participants. While there are multiple levels at which research priority-setting can and does take place, competition between trials often plays out in real time at the institutional or site level, where complex decisions must be made about how to manage overlapping trials in ways that balance different considerations, including the risk of non-completion. We sought to explore what research institutions in particular might ethically do to mitigate the risk that competition between trials will contribute to recruitment shortfalls.

Diversity and Inclusion in Clinical Trials: Concrete Strategies for Enhancing Health Equity

Presentation

Released on: June 14, 2022

Published in: BIO International Convention, San Diego CA

Dr. Willyanne DeCormier Plosky, Program Manager at the MRCT Center, presented on this panel, which explored emerging principles and concrete strategies for addressing demographic disparities and achieving representativeness in clinical trials. The panel was organized and moderated by Lindsay Cobbs (BeiGene USA Inc.), and also included Melika Davis (BeiGene USA Inc.), Jacqueline Corrigan-Curay (FDA); Meg Alexander (Ovid Therapeutics Inc.), and Tesheia Johnson (Yale University) as speakers. See the recording here.

Equity by Design: Utility of a Metrics Framework and Metrics To Evaluate Progress on Diversity, Equity, and Inclusion in Clinical Research

Presentation

Released on: June 14, 2022

Published in: BIO International Convention, San Diego CA

Dr. Willyanne DeCormier Plosky, Program Manager at the MRCT Center, presented on this panel, which was organized by the MRCT Center to discuss the origins, development, structure, and lessons learned from pilot testing of the Equity by Design (EbD) in Clinical Research Metrics Framework. The panel was moderated by Camelia Thompson (BIO), and also included Neha Londono (Seagen Inc.); and Inez Ruiz-White (Otsuka Pharmaceuticals) as speakers. See the recording here.

MRCT Center Annual Meeting

December 6, 2017 @ 8:00 am 1:00 pm

Loeb House at Harvard University, Cambridge, MA

MRCT Center 2017 Annual Meeting Agenda

MRCT Center 2017 Annual Meeting Proceedings

MRCT Center 2017 Annual Meeting Slides

MRCT Center 2017 Annual Meeting Keynote Slides

Key themes of the meeting included MRCT Center projects:

  • Introducing a new project: Real World Evidence
  • Core Competencies for Clinical Research Professionals
  • Return of Individual Results: Genomics and Axes of Communication
  • Preview: Global Clinical Trial Data Sharing Platform

The MRCT Center Annual Meeting is open to all MRCT Center stakeholders and the public.

1:00 PM- 4:30 PM, the MRCT Center Executive and Steering Committee met in closed session.

Deliverables

Projects