How To Limit Uninformative Trials: Results From A Delphi Working Group

Publication

Published on: April 18, 2023

Published inCellPress Med

Free access until June 7, 2023

Description: Drs. Barbara Bierer, Luke Gelinas, Nora Hutchinson, and Deborah Zarin deployed a modified Delphi process to establish consensus on 35 recommendations across five domains related to the role of scientific review and landscape analysis in preventing uninformative trials. Their article, “How to limit uninformative trials: Results from a Delphi working group,” was recently published in Med.

Permanent Link

IRR: Returning Non-validated Test Results

Case Study

Presented on: March 27, 2023

Description: This case study describes how an IRB navigated returning results of a new COVID-19 assay from a non-CLIA-certified lab during a public health emergency.

Related Resources:
Link to IRR Roadmap by Role.

A Global Standard For Plain Language In Clinical Research: MRCT Center And CDISC Collaboration

Webinar

Date: April 5, 2023

A discussion about the MRCT Center’s collaboration with CDISC to promote the MRCT Center’s Clinical Research Glossary, a freely available plain language glossary of commonly used clinical research terms developed with and for patients and their caregivers, as a global research standard.

Learn about the MRCT Center’s robust process of developing the plain language glossary, the CDISC public review process, and how this collaboration will empower patients and participants with the necessary tools and information to make informed research decisions.

Related Resources:

Presentation Slides
Audience Q&A
Speaker Bios

Link to Public Review Website
Helpful Video Tutorial about how to submit a Public Comment
Link to a Public Review Outreach Template

Accessibility by Design (AbD) Toolkit Release

Webinar

Date: May 4th, 2023

Description: Learn about the Accessibility by Design (AbD) in Clinical Research Toolkit, developed by the MRCT Center in collaboration with people with disabilities, caregivers, allies, disability rights advocates, and stakeholders working in clinical research.

We present the background, structure, and key themes of the AbD Toolkit. Invited speakers then discuss their experiences as participants, caregivers, and leaders in clinical research and how the AbD Toolkit may be utilized to facilitate change.

Webinar

Related Resources:
Accessibility by Design (AbD) Toolkit

Webinar Slides

Excluding People with Disabilities from Clinical Research: Eligibility Criteria Lack Clarity and Justification (Publication)

Supported decision-making can advance clinical research participation for people with disabilities (Publication)

Integrating Supported Decision-Making into the Clinical Research Process (Publication)

MRCT Center Leaning In Webinar Series: Driving Inclusion in Clinical Research – June 9, 2021: Improving Inclusion of Persons with Disabilities in Clinical Research (WEBINAR)

MRCT Center Diversity, Inclusion, and Equity in Clinical Research Guidance Document and Toolkit

Equity by Design in Clinical Research: The EbD Metrics Framework (FRAMEWORK)

DEI in Clinical Research: Tools & Resources for Incorporating DEI in IRB/HRPP Processes (AAHRPP poster)

Poster

Presented on: May 2023

Presented at: 2023 Annual AAHRPP Conference

The MRCT Center has developed a set of practical diversity, equity, and inclusion (DEI) tools for IRBs and HRPPs, designed to improve the involvement of underrepresented populations in clinical research. In 2021, a task force of 28 IRB and HRPP professionals, convened by the MRCT Center, created 15 DEI tools. The tools underwent rigorous review and revision during nine months of monthly meetings and additional correspondence. 

Three highlighted tools in the poster include:

  • Checklist of Logistical and Procedural Considerations: Assists in lowering barriers to inclusion, covering Pre-Study, On-Study, and Post-Study Considerations.
  • HRPP Planning Strategy to Address DEI: Offers a plan involving support, key stakeholders, guidance utilization, and process evaluation.
  • Incorporation of Diversity and Inclusion into Clinical Research Protocol Templates: Provides DEI recommendations within protocols, along with annotated examples.

Hayat Ahmed, MS, Program Manager at the MRCT, showcased this poster at the Annual AAHRPP conference in May 2023. Conference participants awarded Ms. Ahmed the distinguished poster prize.