Office of Minority Health Progress Update

Jonca Bull, MD

February 29, 2016

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2016- The Year of Clinical Trial Diversity
Priority One: 

Improve the Completeness and Quality of 

Demographic Subgroup Data (Quality)

1.1 Reviewing and developing a work-plan for updating 

and/or finalizing, relevant guidance on demographic 

subgroup data

– Update of 2005 Industry Guidance on the Collection of Race 

and Ethnicity Data 

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Priority One: 

Improve the Completeness and Quality of 

Demographic Subgroup Data (Quality)- cont 

1.3 Strengthen FDA Reviewer training by adding education/training 

around demographic inclusion and health disparities (prevalence, 

severity, disease course)

– December, 2015 FDA-Johns Hopkins/CERSI Workshop: “Clinical 

Trials: Assessing Safety and Efficacy for a Diverse Population” 

1.4 Enhancing FDA’s systems for collecting, analyzing and 

communicating diverse clinical information to optimize safe and 

effective use of medical products in diverse populations over the 

total product life cycle

– Medwatch forms have been revised to include data fields to 

collect race and ethnicity data 
Priority One: 

Improve the Completeness and Quality of 

Demographic Subgroup Data (Quality)- cont 

1.5. Conducting research on specific areas of public health concern 

related to demographic subgroups 

– OMH plans to develop research projects leading to better 

understanding of medical product clinical outcomes in 

racial/ethnic demographic subgroups 

1. “Racial And Sex Difference In Prosthetic Aortic Valve Selection And Risk 

Factors For Patient Outcome—An Observational Study Of Medicare 

Beneficiaries”

2. “An Epigenome-Wide Association Study (EWAS) of Peripheral Blood 

Mononuclear Cells from African American and European American Women 

With and Without Lupus”

3. “Molecular Characterization of Racial Disparities and Outcome in Multiple 

Myeloma”

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Race Differences Reported for PK, Safety, and 

Efficacy for Approved NMEs

6 Ramamoorthy A, et al., CPT, 2015
Labeling Recommendations 

 

Ramamoorthy A, et al., CPT, 2015 7 
Priority Two: Participation- identifying barriers to 

subgroup enrollment in clinical trials and employing 

strategies to encourage greater participation

2.1 Seeking further clarity about barriers to subgroup participation rates

• April, 2015 Institute of Medicine Roundtable : “Strategies for Ensuring 

Diversity, Inclusion, and Meaningful Participation in Clinical Trials”

• University of Maryland project with School of Public Health/Center for Health 

Equity 

2.2 Implementing Efforts to Enhance Appropriate Use of Enrollment Criteria in 

Clinical Trial Protocols

• September, 2015 OHOP-OMH Mini Symposium: “Racial/Ethnic Representation 

in Oncology Clinical Trials In the Era of Precision Medicine”

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Priority Two: Participation- identifying barriers to 

subgroup enrollment in clinical trials and employing 

strategies to encourage greater participation

2.3 Collaborating with NIH, Industry and other interested 

stakeholders to broaden diverse participation in clinical research

– NIH Inclusion Governance Group 

– September, 2015 OMH-NLM webinar: “Get to Know Clinical 

Trials.gov!”

– Work with community groups- sit on planning/steering 

committees for meetings and conferences (ex: AWARE for Alleducating patients about clinical research) 

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Priority Two: Participation- identifying barriers to 

subgroup enrollment in clinical trials and employing 

strategies to encourage greater participation

2.4: Using FDA’s communication channels to encourage clinical 

trial participation by demographic subgroups

— Developing 6 PSA’s to raise awareness about clinical trial 

diversity, with plans to translate into other languages 

— Written (or contributed) articles for FDA Voice Blog, Patient and 

Provider Network newsletter, external blogs (ex: APHA), and 

consumer updates 

— Clinical trials and minorities webpage, brochure/infographic 

translated in Spanish 

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Concluding thoughts

• Inclusion of US racial/ethnic demographic subgroups in clinical 

trials in adequate numbers are important to look for differences 

that impact the safety and efficacy profile of the medical 

products in US demographic subgroups

• Medical product development is increasingly carried out EX US 

– Study populations less representative of the US demographic subgroups

– Limitations in characterizing drug safety and efficacy in US populations

– Limit access to clinical trials in the US

• Big data may play a role in helping to close the gap

• Continued initiatives are needed to increase the 

enrollment of underrepresented demographic 

subgroups in FDA clinical trials

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Acknowledgments 

Katty Augustin

Katherine Bravo

Shakia Baskerville

Naureen Islam

Sydnee Logan

Martin Mendoza

Christine Merenda

Cariny Nunez

Jovonni Spinner

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Questions?