Clinical Trials & Research Archives

Response To FDA’s Request For Comments On Strategic Priorities For The Office Of Minority Health And Health Equity (OMHHE)

Public Comments

Comments provided on: June 29, 2020

Comments provided to: Food and Drug Administration (FDA)

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Biopharmas Must Address The Reality Of Racial Disparities In Health Outcomes Exposed By Covid-19

Publication

Presented on: September 8, 2020

Published in: BioCentury

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Heterogeneity of Treatment Effects in Clinical Trials: Methods and Innovations

Goals:

Gain a common understanding on the desired goals of subgroup analyses
Establish standards for assessing effects within subgroups and for defining meaningful differences in effect between subgroups
Review the characteristics, assumptions, advantages and limitations of traditional and innovative models for subgroup analyses
Review contribution of data visualization techniques to complement and enhance statistical modeling approaches and interpretation
Develop and communicate recommendations

🎥 Watch the webinar recording:

Day 1
Day 2

2020 BIO BOOKLET

Day 1: Monday, November 30, 2020

TIME	PROPOSED AGENDA	PROPOSED SPEAKERS
8:30-8:45	Welcome Opening remarks (MRCT Center)	Richardae Araojo Sylva Collins Barbara Bierer
8:45-9:10	Keynote speaker: A clinical trialist’s perspective “System Redesign needed to make sense of findings that suggest heterogeneity of treatment effect”	Robert Califf
9:10-10:15	Challenges for the Regulator, Clinician, and Patient: Population safety and efficacy but individual treatment Moderator: David Strauss	Christopher Granger Ellis Unger Janet Wittes Donna Cryer Danielle Campbell Aloka Chakravarty
10:15-10:30	Break
10:30-11:00	Goals of subgroup analyses, assessing standards for analysis of differences, and limits of interpretation	Steven Snapinn
11:00-11:30	Subgroup identification: Utility, impact, and methods	Scott Evans
11:30-12:45	Statistical Methods I Moderator: Li Chen	Stuart Pocock Stephen Ruberg Lisa Lavange Mark Rothmann Kathleen Fritsch Ravi Varadhan
12:45-12:50	Closing remarks	Richardae Araojo and Barbara Bierer

Day 2: Tuesday, December 1, 2020

Time	Proposed Agenda	Proposed Speakers
8:30-9:30	Statistical Methods II Moderator : Steve Snapinn	Donald Berry Thomas Louis Gene Pennello Frank Bretz
9:30- 10:00	Summary Discussion of Statistical Methods I and II
10:00-10:15	Break
10:15-11:15	Data Visualization and the role of graphical representation Moderator: Marcia Levenstein	Frank Harrell Ilya Lipkovich Michael Griswold
11:15-12:15	Panel: Statistical methodologies, pros and cons Moderator: Thomas Gwise	Frank Rockhold Qi Jiang Thomas Gwise John Scott
12:15-12:45	Open discussion and Conclusions	FDA and MRCT Center
12:45- 1:00	Core team to discuss Day 1 & Day 2 wrap up	Planning committee

GLOBAL CLINICAL RESEARCH SUMMIT 2018

September 7, 2018 @ 11:00 am – 12:00 pm

Seoul

Dr. Barbara Bierer, MRCT Center Faculty Director, will be speaking on “Improving the Performance of Clinical Trial for Global Directives” at the Global Clinical Research Summit in Seoul on September 7th. Learn more

A Global Standard In Plain Language For Clinical Research: A Joint Webinar By The MRCT Center And CDISC

April 5, 2023 @ 11:00 am – 12:00 pm EDT

Virtual Event

Description: We are delighted to announce a collaboration with Clinical Data Interchange Standards Consortium (CDISC) on the MRCT Center Clinical Research Glossary. This marks an important first step in making plain language a global clinical research standard. The MRCT Center Clinical Research Glossary was piloted in 2020 to test the process of creating a plain language glossary of commonly used clinical research terms that is freely available to everyone.

Please join us on April 5 from 11 AM – 12 PM ET for a joint webinar with the MRCT Center and CDISC. Learn about MRCT Center’s robust process of developing the plain language glossary, the CDISC public review, and how this collaboration will empower patients and participants with the necessary tools and information to make informed research decisions.

Click here to register.

Deliverables

Projects

Publications

April 5, 2023: A Global Standard For Plain Language In Clinical Research: MRCT Center And CDISC Collaboration

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

Publication

Published on: April 18, 2023

Published in: CellPress 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.

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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.

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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.

View Webinar

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.