Diversity

Grand Rounds January 17, 2025: Design for Diversity: Designing Studies for Representativeness and Generalizability (Christopher J. Lindsell, PhD)

Posted on by Sophia Ramirez

Speaker

Christopher J. Lindsell, PhD
Professor and co-Chief, Biostatistics, Duke University
Director, Data Science and Biostatistics, DCRI
Director, Biostatistics and Bioinformatics, CTSI
Editor in Chief, Journal of Clinical and Translational Science

Keywords

Study Design; Diversity; Health Disparities; Evidence Generation

Key Points

  • Health disparities are factors that contribute to preventable differences in health status and outcomes. They can be environmental, sociocultural, behavioral, and biological. These are preventable differences with adverse effects for populations.
  • When research teams don’t consider factors that change outcomes for certain populations but not others, research can contribute to a difference in health status and outcomes. A flawed evidence generation system compounds the problem.
  • One popular solution is to measure and adjust for diversity variables; however, research teams often get the variable wrong or use it incorrectly.
  • By designing for diversity, research teams can begin to address the generalizability of evidence; develop an understanding of factors that contribute to success or failure of interventions among diverse populations; and remove the evidence generation system as a contributor to health disparities.
  • Designing for diversity is an optimization problem. Historically, study designs have been optimized for the researcher; Dr. Lindsell proposed that researchers optimize for the participant.
  • Research that is optimized for the participant is rigorous and flexible; safe and practical; and complete and simple. Participants should be embedded in every part of the research process. This can be difficult – there are tradeoffs involved – but it is effective.
  • The interface between data generation and data use is crucial. Making systems that work to bring in the right information and systems that use that information appropriately are two pieces of the same puzzle.
  • Dr. Lindsell included a call to ditch the ordinary subgroup analysis, noting that groups are not binary and not all groups have meaning. He suggested a focus on interaction terms.

Discussion Themes

Institutions should be supporting research teams in their ability to achieve diversity; this should be a matter of course, rather than something to be achieved without support and then celebrated as a remarkable accomplishment.

Looking forward, as data infrastructure becomes increasingly robust, research teams and communities may be able to collaborate to build a more complete understanding of individuals’ health states and who may be in need of an intervention.

Grand Rounds August 19, 2022: Inclusion and Diversity in Clinical Trials: Actionable Steps to Drive Lasting Change (Gerald Bloomfield, MD, MPH; Michelle Kelsey, MD)

Posted on by Elizabeth Mccamic

Speakers

Gerald Bloomfield, MD, MPH
Associate Professor with Tenure, Medicine
Associate Professor, Global Health
Duke University School of Medicine

Michelle Kelsey, MD
Assistant Professor of Medicine
Duke University School of Medicine

 

 

Keywords

Diversity, Inclusion

 

Key Points

  • There is a national priority to increase diversity in clinical trials, from regulatory, funding agencies, industry, and others, so that the participant population reflects the U.S. population at large, which is steadily becoming more diverse.
  • The Duke Clinical Research Institute (DCRI) organized and sponsored a Think Tank to address diversity in clinical trial research. It was held virtually on April 28-29, 2021. Participating organizations included FDA, NIH, academic institutions, pharmaceutical and device companies, patient advocacy groups, community groups, and data groups, and representatives from each organization had opportunity to extend invitation to others.
  • Three key themes emerged from the Think Tank discussion: build partnerships with participants and communities; improve accessibility of clinical trials; improve representation among clinical investigators.
  • For the theme of building partnerships, community engagement was identified as particularly effective for recruitment of racial and ethnic minority groups. In systematic reviews, community involvement and partnership with community-based organizations are universally cited as key to success. Communities should be involved from the very beginning where both the community and investigators take ownership of the research and are equally involved and interested.
  • For the theme of improving the accessibility of clinical trials, the Think Tank identified steps such as decentralizing clinical trials to reduce geographic barriers, using digital tools, and leveraging community infrastructure already in place to improve accessibility to clinical trials.
  • For the theme of improving representation and diversity among clinical investigators, having a more representative clinical trial workforce might translate to more diverse participants. We have seen that having a higher proportion of women authors resulted in a higher proportion of women enrolled per trial. To prioritize diversity in the clinical research workforce, institutions should hire individuals from under-represented groups and offer support and mentorship of their research endeavors.

Discussion Themes

-Is there low hanging fruit we should encourage people to focus on? Where to start? This is an issue that a number of institutions have been thinking about for some time. We have made tremendous progress with some of the programs that Michelle alluded to, programs that are developing a pipeline of researchers. In terms of untapped potential, the engagement with the community, taking the time to identify who folks are and speak face to face. Ask questions like here’s what we think are priorities; are we right? Ask and engage community partners.

–How do investigators target rural areas to increase diversity? This is one of the biggest gaps that we do not have a solution for yet in the clinical trial space. NIH has done a lot with epidemiological research to reach, engage, understand rural populations. The face-to-face component, the time in front of individuals is a critical step to being welcomed and to engaging people in rural settings.

Learn more
Read about the DCRI Think Tank results: Inclusion and diversity in clinical trials: Actionable steps to drive lasting change.

Tags

#pctGR, @Collaboratory1

Grand Rounds August 12: Equitably Including Diverse Participants in Pragmatic Clinical Trials (Consuelo H. Wilkins, MD, MSCI)

Speaker:

Consuelo H. Wilkins, MD, MSCI
Senior Vice President and Senior Associate Dean
for Health Equity and Inclusive Excellence
Professor of Medicine
Vanderbilt University Medical Center

 

Topic: Equitably Including Diverse Participants in Pragmatic Clinical Trials
Date: Friday, August 12, 2022, 1:00-2:00 p.m. ET

 

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June 14, 2022: Including Diverse Participants in Pragmatic Clinical Trials

Posted on by Elizabeth Mccamic

In an interview at the NIH Pragmatic Trials Collaboratory Steering Committee meeting in April, Drs. Rosa Gonzalez-Guarda, Rachel Gold, and Karen A. Kehl discussed the importance of including diverse participants in pragmatic clinical trials and the challenges investigators and community health centers face engaging underrepresented populations in research.

During the discussion, Gonzalez-Guarda, Gold, and Kehl identified some of the challenges investigators must address in order to include diverse populations in pragmatic trials, such as inequalities in access to healthcare, under-resourced community health centers and funding mechanisms that do not accommodate research in community settings, and lack of infrastructure for research in settings outside of academic health centers.

“I think the biggest challenge that we have is that we know there are inequities in access to healthcare to begin with so if we are not thoughtful about the integration of pragmatic clinical trials within a system that already lacks accessibility to many populations, I think that is a huge challenge that we need to overcome,” said Gonzalez-Guarda of Duke University.

Changes to the way research is funded is one step that could better support research that includes diverse populations.

“Through the Collaboratory, we have used a lot of collaborative mechanisms that allow some of that building of community-based resources in the planning phases,” said Kehl of the National Institute of Nursing Research. “The Collaboratory and HEAL Initiative have had some particular supplements that are looking just at engaging diverse populations and adding to the diversity and inclusion of a study.”

Other areas to focus on include building relationships within the community, developing partnerships and infrastructure for research at community health centers, and ensuring the study content is of interest to the clinic and patients.

“My experience of 15 years of doing pragmatic trials with community health centers has focused on outcomes that are of most interest to the primary care providers, which is a lot of times going to be around maternal-child health, opioid pain management, hypertension, and diabetes—what the patients are coming in for the most and in a lot of cases [what] the clinics have a quality metric that they have to report on,” said Gold of Kaiser Permanente Center for Health Research.

Gonzalez-Guarda hopes the NIH Pragmatic Trials Collaboratory will help lead the way in putting change into action.

“There’s a lot of expertise already in the Collaboratory and success on engaging diverse populations, not only as participations of those studies [but also] as partners, and those are things that I would love to elevate and integrate into our Living Textbook as well as creating some trainings,” Gonzalez-Guarda said. “Another strategy that we need to think about is diversifying the workforce of individuals and investigators that have the expertise in this area because we do know that makes an impact in terms of encouraging diverse participation and engagement in clinical trials.”.

View the full interview.

See the complete materials from the 2022 Steering Committee meeting.

May 4, 2022: Ethics Core Members Pen Guest Editorial for AJOB Focus on Machine Learning in Healthcare

Posted on by Damon Seils
In a guest editorial in the American Journal of Bioethics, members of the NIH Pragmatic Trials Collaboratory’s Ethics and Regulatory Core introduced the issue’s target article and peer commentaries on artificial intelligence and machine learning in healthcare. Prof. Kayte Spector-Bagdady and Drs. Vasiliki Rahimzadeh and Kaitlyn Jaffe, who are Core members, were joined by coauthor Dr. Jonathan Moreno in writing the editorial.

The target article of the themed collection proposes a research ethics framework for the clinical translation of healthcare machine learning. In several peer commentaries accompanying the article, experts offer their perspectives on the proposed framework, including critiques of “the insufficiency of current ethics and regulatory solutions to adequately protect communities at higher risk for [machine learning] bias.”

Read the full editorial, “Promoting Ethical Deployment of Artificial Intelligence and Machine Learning in Healthcare.” Learn more about our Ethics and Regulatory Core.

April 14, 2022: FDA Announces New Draft Guidance for Increasing Enrollment of Diverse Populations in Clinical Trials

Posted on by terren.green@duke.edu

FDA logoThe US Food and Drug Administration (FDA) issued draft guidance yesterday recommending clinical trial sponsors develop a “Race and Ethnicity Diversity Plan” to ensure representative enrollment of racially and ethnically diverse participants in clinical trials developing medical products.

The draft guidance, Diversity Plans to Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials Guidance for Industry, updates previous FDA guidance issued in October 2016. The “Race and Ethnicity Diversity Plan” is recommended for studies submitting IDE or IND applications to the FDA for approval of an investigational drug or device. The updated guidance provides information about 5 elements that should be included in the plan:

  • Overview of the disease/condition
  • Scope of medical product development program
  • Goals for enrollment of underrepresented racial and ethnic participants
  • Specific plan of action to enroll and retain diverse participants
  • Status of meeting enrollment goals

Achieving heath equity for underrepresented racial and ethnic populations starts with appropriate representation in clinical trials. Disease burden is often higher for underrepresented populations, yet barriers to participation in clinical trials may prevent adequate enrollment. Improving racial and ethnic diversity in clinical trials ensures that results are generalizable and medical discoveries are safe and effective for all patients.

The draft guidance was a collaborative effort between the Oncology Center of Excellence’s Project Equity, the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health.

Read the FDA news release.

March 17, 2022: NIH Will Fund New NIH Collaboratory Trials That Address Health Disparities

Posted on by Damon Seils

Promotional banner for funding opportunity announcementThe NIH released a request for applications (RFA) for new NIH Pragmatic Trials Collaboratory Trial grants that address health disparities. NIH program and review staff will discuss the funding opportunity in an upcoming webinar. Registration for the webinar is required.

The RFA for this funding opportunity encourages applications that focus on improving health outcomes in populations that experience health disparities, such as higher rates of disease or mortality compared with the general population. Applications are due June 17, 2022. Letters of intent are due 30 days prior (May 17, 2022).

For the purposes of this funding opportunity, the NIH-designated U.S. health disparity populations definition includes: Blacks/African Americans, Hispanics/ Latinos, American Indians/Alaska Natives, Asian Americans, Native Hawaiians and other Pacific Islanders, socioeconomically disadvantaged populations, underserved rural populations, and sexual and gender minorities. 

Similar to the NIH Pragmatic Trials Collaboratory’s other NIH Collaboratory Trials, the new projects will have a planning and implementation phase and will be large-scale pragmatic or implementation trials that are embedded in healthcare delivery systems. The overarching goal of the projects is to improve care delivery and health outcomes across the lifespan.

Read our Living Textbook chapter about how to develop a compelling grant application for a pragmatic clinical trial.

October 26,2021: New Article Examines Justice and Equity in Pragmatic Clinical Trials

Posted on by Karen Staman

Learning Health Systems

In a new article published recently in Learning Health Systems, colleagues from the Pain Management Collaboratory examined challenges related to justice and equity in pragmatic clinical trials (PCTs) on pain management.

Based on our experience with PCTs in health systems that serve military and veteran populations,  we suggest it is particularly important to recognize that: (a) some individuals with chronic pain are vulnerable to injustice, (b) structural and sociocultural challenges that exist within health systems can complicate chronic pain research, and (c) PCTs involving NPTs [nonpharmalogical treatments] provide one lens through which injustices may be identified and addressed with the proactive input of a broad range of stakeholders.

Broadly engaging diverse stakeholders throughout the lifecycle of a PCT will take creativity, and the authors suggest specific strategies to enhance justice and equity for different phases of a PCT, including conduct and design, recruitment, selection and implementation of interventions, and stakeholder engagement .

Within learning health systems, principles of continuous learning and feedback to improve care can potentially be put to use not only to secure value in healthcare, but also to support evidence development to guide equitable practice.

Read the full article.

October 25, 2021: NIH HEAL Initiative Issues RFA for Projects that Advance Health Equity in Pain Management

Posted on by terren.green@duke.edu

The Helping to End Addiction Long-termSM Initiative, or NIH HEAL InitiativeSM recently announced a funding opportunity for new studies that aim to develop, test, and implement interventions that mitigate bias, discrimination, socioeconomic, or environmental barriers to quality pain assessment, treatment, and management for populations that experience health disparities (HDPs) in the United States.

For the purposes of this funding opportunity, the NIH-designated U.S. health disparity populations definition includes: Blacks/African Americans, Hispanics/ Latinos, American Indians/Alaska Natives, Asian Americans, Native Hawaiians and other Pacific Islanders, socioeconomically disadvantaged populations, underserved rural populations, and sexual and gender minorities.

The NIH HEAL Initiative supports research to improve treatment for opioid misuse and addiction and enhance pain management. This RFA calls for applications that “demonstrate an existing health disparity or health disparities in acute and/or chronic pain in the population of interest and outline a detailed plan for an evidence-based intervention to mitigate or eliminate the disparity(disparities) to improve pain and pain-related outcomes.”

Applications are due by 5pm on December 9, 2021.  Letters of intent are due 30 days prior (November 9, 2021).

This award will support a 1 to 2-year, milestone-driven planning phase (R61) with the possibility of an additional 4-year implementation phase (R33).

Read the full request for applications.

The Helping to End Addiction Long-termSM Initiative, or NIH HEAL InitiativeSM, is an aggressive, trans-NIH effort to speed scientific solutions to stem the national opioid public health crisis. Launched in April 2018, the initiative is focused on improving prevention and treatment strategies for opioid misuse and addiction, and enhancing pain management. For more information, visit: https://heal.nih.gov.

October 19, 2021: NIH Issues RFA for New NIH Collaboratory Trials That Address Health Disparities

Posted on by Karen Staman

NIH logoThe NIH recently released a request for applications (RFA) for new NIH Collaboratory Trial grants. The RFA encourages applications that focus on improving health outcomes in populations that experience health disparities, such as higher rates of disease or mortality compared with the general population. These populations may be defined by race, ethnicity, geography, or socioeconomic status.

Applications are due December 15, 2021. Letters of intent are due 30 days prior (November 15, 2021).

For the purposes of this funding opportunity, the NIH-designated U.S. health disparity populations definition includes: Blacks/African Americans, Hispanics/ Latinos, American Indians/Alaska Natives, Asian Americans, Native Hawaiians and other Pacific Islanders, socioeconomically disadvantaged populations, underserved rural populations, and sexual and gender minorities. 

Similar to the NIH Collaboratory’s other NIH Collaboratory Trials, the new projects will have a planning and implementation phase and will be large-scale pragmatic or implementation trials that are embedded in healthcare delivery systems. The overarching goal of the projects is to improve care delivery and health outcomes in Americans across the lifespan.

Read the full request for applications.

Read our Living Textbook chapter about how to develop a compelling grant application for a pragmatic clinical trial.