MRCT Center Leaning In Webinar Series

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We are happy to announce a new series of MRCT Center Leaning In Webinars: Driving Inclusion in Clinical Research.  This series will focus on how to approach and plan for inclusion, implement recommendations, and sustain progress. The sessions will introduce tools, resources, and will feature speakers who will share their experiences and recommendations for how to improve diversity and inclusion in clinical research.  

Please note, the MRCT Center Leaning In Webinar Series: Practical Approaches to Improving Diversity in Clinical Trials was held October 2020 through February 2021 and focused on topics and recommendations addressed in the MRCT Center’s “Achieving Diversity, Inclusion, and Equity in Clinical Research” Guidance Document and Toolkit.  Check out webinar recordings and slides available from this series below.

MRCT Center Driving Inclusion in Clinical Research webinars

We are pleased to invite you to join the next round of the MRCT Center Leaning In Webinar series: Driving Inclusion in Clinical Research. The first session of the series, titled How to Begin, will be Wednesday, April 14, 2021 from 11am – 12pm EDT.

Our moderator will be MRCT Center Faculty Director, Barbara Bierer, MD. Our guest speakers will be Anya Harry, MD, PhD, Head, Global Demographics & Diversity at GlaxoSmithKline and Christopher Romero, MD, PhD, FACP, Medical Director, USA, at PanAmerican Clinical Research.

The inclusion of diverse populations in clinical research requires steady commitment and focus and is necessary to reduce disparities and inequity in health care. Further, inclusion in clinical research requires an integrated approach across the different stakeholders. It is often difficult to determine where and how to begin this process.

In this session of the MRCT Center’s ‘Leaning-in’ Webinar Series, speakers will discuss:

  • How to plan, resource, and develop a program to address diversity and inclusion in clinical research
  • Strategies of and with leadership to commit to and set expectations for diversity initiatives
  • Examples and experiences of organizations that are building and maintaining momentum toward inclusion in clinical research

🎥  Watch webinar recording    ⬇️ Download slides

Please join us for the MRCT Center Driving Inclusion in Clinical Research webinar: Inducement or Fair Compensation? Impact on Diverse Participation on Wednesday, May 12, 2021 from 11am – 12pm EDT.

Our moderator will be MRCT Center Faculty Director, Barbara Bierer, MD. Our guest speakers will be:

  • Luke Gelinas, PhD, Senior Advisor at the MRCT Center and Chairperson at Advarra IRB
  • Melissa Gonzales, PhD, Inclusion Principal, External Partnering in the Chief Diversity Office at Genentech
  • J. Leonard Lichtenfeld, MD, MACP, Medical Oncologist and former Deputy Chief Medical Officer for the American Cancer Society
  • Joseph Liss, JD, Associate at Ropes & Gray, LLP

Participation in clinical trials from diverse and underrepresented populations is influenced by various patient-specific, provider-specific, and policy-related factors. While recent efforts are underway to evaluate, address, and remedy underrepresentation, the ethical debate around payment for research participation persists. While payment of research participants is common practice in research, stakeholders are often concerned that payment may bias potential participants’ decision-making, resulting in undue inducement. Thoughtful attention to participant’s autonomy interests — protecting participants from undue influence by the offer of payment — and to the broader aims of access to clinical trials, diversity, and fairness is important must be balanced.

In this session of the MRCT Center’s ‘Leaning-in’ Webinar Series, panelists will discuss:

  • Ethical payment principles that help to ensure participants’ autonomy
  • Understanding the three categories of research payment: 1) reimbursement, 2) compensation, and 3) incentive payments
  • Approaches to fair payment that do not risk undue inducement

🎥  Watch webinar recording    ⬇️ Download slides

Clinical research studies often fail to provide access to trials for individuals with disabilities—when the research focuses on topics unrelated to the disability itself. While some scientific, safety, or ethical reasons to exclude individuals with disabilities in research may exist, often exclusion is based, at least in part, in the perceived inability to provide appropriate accommodations.  The foundational ethical principles of human research – respect, beneficence, and justice – provide the rationale for offering the equal opportunity to pursue and participate in clinical research to those with disabilities. Planning for research inclusion and correcting inadvertent or unintentional exclusion of persons with disabilities requires planning and forethought. Here, in the first session of improving inclusion of persons with disabilities, we will address the inclusion of persons with physical, auditory, speech, and vision disability. Considerations for inclusion of persons with cognitive and developmental disabilities in research will be addressed at a later time.

In this session of the MRCT Center’s ‘Leaning-in’ Webinar Series, guest speakers will discuss:

  • The legal and ethical justifications for the inclusion of people with disabilities in clinical research
  • Strategies for addressing barriers to inclusion of persons with certain disabilities
  • Universal Design of Research for persons with certain disabilities
  • Accommodations and considerations to advance inclusion of persons with certain disabilities

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The requirement to translate clinical research related documents varies from country to country and site to site. Appropriate translation of clinical research documents and materials, however, is important for ensuring a safe and equitable clinical trial, whether the research be global or local in nature. Accurate and appropriate translation of study materials impacts participant representation, and downstream of that the applicability and generalizability of the research findings. In the United States, study documentation for participants and investigators is generally available in English; translation is highly variable.  For those lacking English proficiency, language barriers present a disadvantage both in comprehension and in research participation.  Simply put, individuals should not be at a disadvantage or excluded from studies simply due to lack of translated materials or English proficiency, but any commitment to translation must address cost, efficiency, and resource needs.

In this session of the MRCT Center’s ‘Leaning-in’ Webinar Series, panelists will discuss:

  • Ethical and legal mandates for language rights in healthcare including clinical research
  • Barriers around translation of clinical research materials
  • Potential solutions to reduce the burden of translating study materials

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MRCT Center Leaning In Webinar Series October 2020 - February 2021

Participants in clinical research should reflect the population affected by the disease, or those intended to utilize the intervention. Early and active engagement from participants, patients, caregivers, and communities can influence and improve the design and execution of clinical research, including efforts to enhance diversity and inclusion. Further, appropriate and meaningful engagement offers opportunities for outreach to individuals and communities including those underrepresented or underserved in research, addresses priorities that are important for patients and potential participants, and to draws upon the perspectives of the very individuals for whom the research is intended.

In the first of seven of the MRCT Center’s ‘Leaning-In’ Webinar Series, speakers will discuss:

  • The importance of community engagement in improving diverse representation in clinical research and research outcomes.
  • Strategies to effectively and mindfully engage with the community and how to introduce clinical research in a respectful and culturally sensitive way.
  • How clinical trialists can utilize and adapt the MRCT Center’s Guidance Document and Toolkit to plan for community engagement.
  • Success and failure stories from the experts in the field
🎥  Watch webinar recording           ⬇️   Download slides

We are pleased to invite you to our webinar on Workforce Development as part of the MRCT Leaning In: A Webinar Series – Practical Approaches to Improving Diversity in Clinical Trials. Moderated by Luther Clark, MD Deputy Chief Patient Officer at Merck, we will be joined by MRCT Center’s Sarah White, MPH to review recommendations made in the Achieving Diversity, Inclusion and Equity in Clinical Research Guidance Document. Guest speakers include Racquel W. Bruton, Senior Clinical Operations Lead at Biogen, and Karen M. Winkfield, MD, PhD, Executive Director at Meharry-Vanderbilt Alliance.

WORKFORCE DEVELOPMENT: A clinical research workforce, including clinicians, investigators, research team members, referring physicians, sponsors, CROs and patient recruitment vendors, should be trained in the skills necessary to support, understand, and communicate with a culturally diverse participant population. A clinical research workforce that is diverse in itself is also better able to prioritize, connect, care for, and successfully recruit a diverse participant population in research.

In the second session of the MRCT Center’s ‘Leaning-In’ Webinar Series speakers will discuss:

  • The opportunities to enhance and train clinicians and healthcare providers on cultural competence, humility and implicit bias
  • The importance of a diverse participant pool in clinical research
  • Strategies companies can utilize to improve their own workforce diversity
  • How clinical trialists can utilize and adapt the MRCT Center’s Guidance Document and Toolkit to evaluate and enhance their Workforce Development
  • Success and failure stories from experts in the field
🎥  Watch webinar recording           ⬇️   Download slides

Join us for the MRCT Leaning In webinar: Study Design, Eligibility, Site Selection & Feasibility on 11/18 at 11am – 12noon ET. Our moderators will include MRCT Faculty Director Barbara Bierer and MRCT Program Manager Laura Meloney, MSc, MPH with guest speakers Rachael T. Fones, Director, Government & Public Affairs, IQVIA and Theresa Devins, DrPH, Associate Director, Global Trial Optimization, Global Clinical Operations at REGENERON.

In clinical research, the study question and study design should consider how diversity and inclusion of underrepresented, understudied, and underserved populations are being addressed. A number of remediable barriers and obstacles exist due to study design, eligibility criteria, and/or site selection that prevent adequate representation from all subgroups – whether that be by race/ethnicity, age, sex, or other demographic data, such as employment status or income level. Proactive planning, coupled with early and continuous engagement with patients and potential participants, is essential to ensure that the clinical research trial is designed to answer appropriate and relevant questions and conducted to accommodate participation from a diverse population.

In the third session of the MRCT Center’s ‘Leaning-In’ Webinar Series, speakers will discuss:

  • How the study question will inform appropriate representation in the clinical research trial and the impact that study design can have on answering the study question
  • The opportunities to involve, engage, and incorporate patients, participants, communities, and advocates to inform study design
  • The importance of broadening eligibility criteria to support inclusion of diverse populations
  • Strategies for successful site selection and accurate feasibility assessments
  • Success and failure stories from experts in the field
🎥  Watch webinar recording     ⬇️   Download slides

Join us for the MRCT Center’s Leaning In webinar: Study Conduct (Recruitment, Retention) on 12/9 at 11am – 12noon ET. Our moderators include ­­­RADM Richardae Araojo, Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity at the U.S. Food and Drug Administration (FDA) and MRCT Center Program Manager Laura Meloney, MSc, MPH. Guest speakers are Quita Beeler Highsmith, MBA, Vice President and Chief Diversity Officer at Genentech, and Anne Marie Inglis, PhD, Senior Director, Global Development Operations at Mallinckrodt.

An individual’s willingness to enroll and participate in clinical research will depend not only on the study objectives, risks, and benefits of the trial, but also upon how the study is conducted.  Study conduct – including the ways in which participants are recruited and retained – pertains to behavioral and logistical practices in clinical research.   Underrepresented populations in research often face barriers to participation that must be understood and addressed in study planning as well as throughout study implementation.  Strategies to engage the desired study population, and later the individual participant, should emphasize the methods that increase the convenience, accessibility, and comfort to participate.

In the fourth session of the MRCT Center’s ‘Leaning-In’ Webinar Series, speakers will discuss:

  • Barriers often faced by clinical research participants, especially those related to underrepresented and underserved populations
  • Overall strategies that trialists should consider to improve study conduct for general and specific subpopulations
  • Recruitment and retention tools available to be adapted to a clinical research trial
  • Success and failure stories from experts in the field
🎥  Watch webinar recording     ⬇️   Download slides

Join us for the MRCT Center Leaning In webinar: Data Standards and Analysis on 1/13 from 11am – 12noon ET. Our moderator will be MRCT Executive Director Sarah White, MPH with guest speakers Roberto Lewis-Fernández , MD, Professor of Clinical Psychiatry, Columbia University; Director, NYS Center of Excellence for Cultural Competence, NYS Psychiatric Institute; Co-Director, Anxiety Disorders Clinic, NYSPI, and Steve Snapinn, PhD, Statistical Consultant, Seattle-Quilcene Biostatistics LLC.

Enrollment of a diverse population in clinical research provides the best opportunity for informed analysis of important subgroups, an important consideration since the benefits and risks of drugs and biologics can vary depending on demographics, comorbidities, genetic differences, and other intrinsic and extrinsic factors. How do clinical trials decide what data to collect and how to collect them?

Currently, the lack of uniformity in collection and reporting of common demographic and non-demographic variables, including age, race, ethnicity, sex, gender, and social determinants of health, both within and across different therapeutic areas in clinical research, limits utility and progress in understanding and the assessment of heterogeneity of treatment effect across different subgroups. Ideally, the collection of demographic and non-demographic data variables should follow a standardized format that enables not only valid statistical analyses, but data aggregation and interoperability over time and across different trials.

In the fifth session of the MRCT Center’s ‘Leaning-In’ Webinar Series, speakers will discuss:

  • Recommendations for establishing common data collection and reporting methods
  • Approaches to and issues of data analysis
  • Lessons from experts in the field

🎥  Watch webinar recording    ⬇️ Download slides

Join us for the MRCT Center Leaning In webinar: Stakeholder Roles and Responsibilities on 1/27 from 11am – 12noon ET. Our moderators will be RADM Richardae Araojo, Associate Commissioner for Minority Health, Director of the Office of Minority Health and Health Equity, U.S. Food and Drug Administration (FDA) and David H. Strauss, MD, Special Lecturer, Columbia University Vagelos College of Physicians and Surgeons and Senior Advisor, MRCT Center. Our guest speakers are Fabian Sandoval, MD, CEO & Research Director, Emerson Clinical Research Institute, Inc., and Leadership Council Member Society for Clinical Research Sites and Emmy Winning Host “Tu Salud Tu Familia” and Medical Contributor Telemundo Washington D.C., and Chris Reddick, MD, Vice President, Head of R&D Health Equity, Center for Health Equity & Patient Affairs at Takeda Pharmaceuticals.

Stakeholders – funders, sponsors, CROs, research institutions and sites, investigators and their study teams, patient and patient advocacy groups and others – are responsible for ensuring that the participant populations in clinical trials are appropriately representative of the anticipated treatment population. No single entity can achieve diversity alone; if it is not an affirmative commitment of all, our individual efforts will fail.

In the sixth session of the MRCT Center’s ‘Leaning-In’ Webinar Series, speakers will discuss:

  • Cross-cutting responsibilities for stakeholders to achieve increased diversity in clinical research
  • The value of organizational commitment to diversity
  • Examples of organization wide initiatives to promote diversity
  • Measuring progress toward diversity’s goals
  • Perspectives from the field

🎥  Watch webinar recording    ⬇️ Download slides

Join us for the MRCT Center Leaning In webinar: Role of Data in Diversity: Genetics and Real World Data on February 10, 2021 from 11am – 12noon ET. Our moderators will be MRCT Center Faculty Director, Barbara Bierer, MD and Luther Clark, MD, FACC, FACP, Deputy Chief Patient Officer at Merck.  Our guest speakers will be Nicole Richie, PhD, Global Head, Health Equity and Population Science at Genentech Roche and Latha Palaniappan, MD, MS, Professor of Medicine at Stanford University School of Medicine.

Recent advances in genetics, genomic technology, and low-cost sequencing have heralded an era of great promise for precision medicine and population health; the possibility that disease prevention and treatment can be individually tailored is the foundational concept of “personalized medicine.”

Genetics and genomics provide important, scientifically objective tools that may help define populations at risk and predict responses to specific treatments. Increasing diversity and inclusion of research participants in genomic and genetic databases and research will increase our knowledge of genomic variants in subgroups and may improve our understanding of disease processes, social determinants of health, individual susceptibility, and response to interventions.

In the seventh session of the MRCT Center’s ‘Leaning-In’ Webinar Series, speakers will discuss:

  • Geographic and genetic ancestry, and the role that genomics plays in health equity
  • How analysis of genomics medicine may enrich or, eventually, replace the use of race, ethnicity, and other surrogate biological markers, and lead to improved application of personalized medicine
  • Approaches for, and the importance of, inclusion and representation in genomic databases
  • Lessons from experts in the field