To achieve tangible outcomes, health care organizations and the biopharma industry needs to implement internal processes for identifying and eliminating the causes of health disparities. Patient advocates and HCPs of color can play a particularly important role in removing barriers to care.
- Examine social determinants of health for patients across different chronic diseases
- Discuss strategies that have been implemented to accelerate these efforts
- Understand how social determinants impact health inequities
- Set targets and build an organization focused on health equity
- Best practices to address unconscious bias
Healthcare and medical inequities impacting underrepresented demographics add up to a staggering $1-2 trillion in economic losses. From both a moral and financial perspective, designing more diverse and inclusive clinical trials is an increasingly prominent goal for the biopharma industry – but how can your team turn that vision into a reality?
- Discuss effective strategies to engage and communicate with the patient community to achieve results
- Examine why the patient’s perspective should be integrated into clinical study development
- Address working with trial sites to ensure diverse and inclusive enrollment
- Meet the patients where they are by moving beyond patient databases
- Identify and engage diverse sites or locations in underserved communities
- Examine the role regulatory agencies play in advancing diversity
- Pamela HaworthDirector of Clinical Research, Program ManagementMedtronic Diabetes
- Stacey BledsoeSenior Director, Clinical Trial Diversity-External EngagementEli Lilly
- Veronica SandovalPh.D., J.D., Principal, Patient Inclusion & Health Equity, Chief Diversity OfficeGenentech
- Jennifer Jones-McMeans Ph.DDivisional Vice President of Global Clinical AffairsAbbott
There are barriers to diversity in clinical trials that you may not see. Trial criteria themselves can limit eligibility; in Black patients, comorbidities such as hypertension, diabetes and chronic kidney disease are common, yet are the top exclusionary comorbidities included in trial protocols in many therapeutic areas. To enable a more diverse and inclusive outcome it is necessary to build the necessary infrastructure at the design of the trial.
- Examine the barriers to access based on eligibility criteria
- Hear suggestions to clearly define relevant study objectives and endpoints
- Identify discrepancies in eligibility criteria that impacts different groups
- Avoid writing protocols that impact eligibility
- Evolve inclusion and exclusion criteria to increase chances for diverse patients to pass screening
Investigator Sponsored Research is an area that may not be considered in most Clinical Trial Diversity initiatives, but it can present a unique opportunity because inclusion lessons from ISR programs can yield benefits for clinical trial design. It can also provide opportunities to investigators studying health inequities, help fill data gaps in underrepresented populations, and enhance community representation in patient recruitment.
- Understand the reasons to incorporate diversity in ISR programs
- Examine realistic options and common challenges when adding diversity in an ISR program
- Strategize the best metrics and next steps
The industry is requesting, and regulators are demanding more diversity in clinical trials. It’s estimated that nearly three out of every four clinical trials today are conducted by contract research organizations (CROs).
- Review what CROs can do to be effective in supporting diversity in clinical trials and champion this work in a unique way sponsors and sites cannot do on their own
- Hear how CROs are uniquely positioned to bridge and support sponsor and site patient diversity efforts
Racial and ethnic minorities represent a disproportionately high fraction (55-62%) of Medicaid beneficiaries, and nearly two-thirds are living with one or more chronic conditions. The Clinical Treatment Act has not only removed a financial barrier for Medicaid beneficiaries to participate in clinical research, it has also created an urgent imperative for all stakeholders in clinical research to learn how to engage the Medicaid population and drive their inclusion in clinical research.
- Discuss strategies to engage the Medicaid population and facilitate clinical trial participation
- Advocate internally for collaborative, community-based strategies to reach the Medicaid population where they live
- Explain why the Clinical Treatment Act matters for increasing representation in clinical trials
What should planning and executing a real health equity strategy look like? This session examines the distinct role and value of patient advocacy, patient engagement, and patient recruitment working together to enable health equity.
- Examine the different roles based on organization size and structure
- Discuss where health equity sits in the organization
- Examine functional consideration based on organizational size and product life cycle
- Maribel BakerDirector, Health Equity & Community ProgramsMedtronic
- Theodora WeiszHead, Patient Advocacy and Public Affairs EMEANovartis Gene Therapies
- Ebony ScottDirector of Health Equity, Lupus Research AllianceLupus Therapeutics
- Lisa LewisMPH, Director Diversity, Equity & Inclusion in Clinical Trials-OncologyJanssen R&D
People of different race, ethnicity, gender, and age do not respond to medication in the same way, yet less than 20% of participants in the key clinical trials that lead to the approval of new medicines are minorities. Partnering with a diverse pool of patients early in the design and development process will build trust, enhance their experience, increase engagement and trial retention rates—and ensure that the drugs being developed are safe and effective across sub-groups.
- Demonstrate the clinical and scientific importance of diversity in early clinical development
- Examine how a patient-centric approach must highlight diversity
- Unveil ways in which patient groups can support drug development through diverse patient recruitment
- Map out wider eligibility criteria earlier in the drug development process
The summer of 2020 sparked conversation and commitments by pharma companies large and small to racial justice and improved equity. During this session, we will examine:
- Review state of the industry, where commitments turned into action – and where they didn’t
- Analyze why a change is needed Examine commitments made in 2020 and beyond
COVID placed greater industry emphasis on remote and decentralized clinical trials, which can be particularly helpful for late-stage studies. DCTs represent a paradigm shift that can yield a greater level of diversity in trials than previously seen.
- Build off guidances from FDA Office of Minority Health and Health Equity to engage diverse populations
- Recognize additional costs outside of the traditional model
- Ensure that your organization can utilize the new structure
A community-centric approach is critical for building trust – and this means identifying the ideal partners and planning out how to get the most from your relationships. Leveraging partnerships between academia, community, government, and industry presents a tremendous opportunity to cultivate and sustain diversity in clinical research.
- Examine meaningful partnerships to foster trust, build scalable and sustainable relationships and solutions
- Examine how patient groups, hospitals, medical education systems, patient advocacy groups can serve as a direct plug into your patient population
- Discuss tactic to build community engagement and partnership to increase study enrollment
- Loredana RegepVP, Medical & Regulatory AffairsRoche
- Maimah KarmoPatient Advocate, CEOTigerlily Foundation
- Safwan KezborM.D., Medical DirectorShiogoni
- Racquel RacadioMPH Director, Representation in Clinical Research (RISE) | Research and DevelopmentAMGEN
- Ramona BuressAssociate Director Diversity, Equity & Inclusion in Clinical Trials Project Management OrganizationJanssen R&D
Clinical studies have continued to struggle to meet enrollment targets especially with diverse patients. Strategic, combined initiatives with advocacy groups is a way to not only get trials in front of these patients, but also to overcome major hurdles of corporate mistrust and benefit company goals of enhancing D&I in clinical research.
- Maximize approach to patient, industry and community alliances
- Ensure alignment with business and commercial strategy
- Recognize patient perspective from advocacy feedback
- Set realistic expectations to build trust and a long term relationship
- Hear best practices to work with patient advocacy groups to increase awareness
Over 75% of clinical studies do not meet their intended patient enrollment goals and health literacy is a significant cause. With lower health literacy more common in underserved racial and ethnic minority groups it is imperative that trial material is understandable, linguistically and culturally appropriate to aid in more diverse recruitment and long term engagement and adherence to medication or use of a device.
- Explore incorporating health literacy practices into clinical trials
- Examine health literacy as a change agent to improve enrollment
- Understand the importance of linguistically and culturally appropriate materials in all research communication
Real-World Evidence can enhance diversity and equity in clinical research, and Real World Data can improve overall data quality. By planning the proper use of both tools, you can pinpoint trial site locations where diversity is higher and results will be more clinically meaningful.
- Examine how RWD/RWE can dramatically improve the representation of patient populations
- Gauge the impact of RWE on decreasing racial disparities in clinical trials
- Utilize RWE to better inform clinical trial design and execution plans to further improve research and development Identify diseases with the greatest diversity unmet need
- Use real-world data to enhance information on diverse populations beyond product approval
Accessible technologies can make or break your inclusive clinical trial network. However, many in underserved communities still face barriers to trial participation as they do have access to technology and broadband.
- Examine how the industry can work with sponsors, CROs, vendors, sites, and networks to increase access to technology and facilitate participation
- Discuss technology and software to bridge physical distance barriers
- Understand if there are prohibitions to providing devices
- Create user ability efficiencies to avoid the exclusion of patients who are not tech savvy or who may not possess the needed devices