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June 30, 2022

Broadening the Lens of Diversity for More Inclusion in Clinical Research

A recent LGBTQ+ focus group reinforces the need to amplify alternative voices to eradicate barriers to participation

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      Malia Lewin

      Malia Lewin

      Life Sciences Strategy Leader

      Guest

    Although there is still a “guinea pig” stigma associated with clinical research participation, for many, clinical trials offer free or low-cost access to testing, care, and cutting-edge treatments that are simply not accessible or available. Years ago, my own mother’s participation in an Alzheimer’s Disease study uncovered a life-threatening condition that she wouldn’t have known about, had she not been a participant. Thankfully, after a required surgery, she is still alive and well. Many other friends, family, and colleagues have shared stories with me about their chronically and terminally ill loved ones who extended their lives and improved their quality of life thanks to clinical trial participation. However inspiring, the commonality across these success stories is that the patients belong to an essentially homogenous population of white, insured patients living in or near urban areas.

    As I have been attending industry events and watching the topic of diversity trend in our sector of the world, I see the emerging initiatives to impact racial and ethnic diversity in clinical research and ask myself whether the pharmaceutical and biotechnology sector can and should do more to leapfrog historic approaches to diversity. That is, instead of simply forcing statistical study populations to reflect traditional demographic categories, can we make trials truly inclusive and inviting to all people so that the resulting participant population is reflective of all facets of culture? If we do this one group at a time – race, ethnicity, religion, biological sex, socio-economic class, etc. – we risk leaving people without access to a valuable health care resource and our industry without access to important information.

    Beyond the Binary

    An important group for our industry to consider are those who identify as being part of the LGBTQ+ community. How one identifies is an integral part of traditional inclusion/exclusion from clinical research trials and limits access for people who do not self-identify in traditional categories.

    A recent survey conducted on Ipsos’ Global Advisor online platform among more than 19,000 individuals aged 16 (or 18, depending on the country), illustrated that on average, 80% of people identify as heterosexual, 3% as gay, lesbian or homosexual, 4% as bisexual, 1% as pansexual or omnisexual, 1% as asexual, 1% as “other,” and 11% don’t know or won’t say. On average, 1% of adults identify as transgender, nonbinary/nonconforming/gender in another way - rather than as male or female.

    Sexual Orientation by Country

    A graph showing identification based on country

    Ipsos LGBT+ Pride 2021 Global Survey

    Question: Which, if any, of the following would you identify as?

    Base:
    19,069 online adults aged 16-74 across 27 countries *Online samples in Brazil, Chile, Mainland China, Colombia, India, Malaysia, Mexico, Peru, Russia, South Africa, and Turkey tend to be more urban, educated and/or affluent than the general population.
    The "Global Country Average" reflects the average result for all the countries where the survey was conducted. It has not been adjusted to the population size of each country and is not intended to suggest a total result.

    As the population of earth approaches eight billion people, we must consider how to engage this important community in healthcare generally and clinical research specifically. Diversity is inherent, inclusion is a choice. This data underscores the need to put aside binary categories and move to criteria that include all eligible patients regardless of how they identify against the traditional paradigm of gender and sexuality.

    Recently, our team partnered with the non-profit organization CISCRP to convene a group of patients who identified as being part of the LGBTQ+ community and explore their experience with the healthcare system generally and clinical research specifically. I had the privilege of participating in the conversation and was stunned by the feedback from the group.

    Key Takeaways

    Over the course of two, two-hour virtual sessions, there was a lot of really interesting discussion. For me, some of the key takeaways were:

    • The LGBTQ+ community is a broad category of communities so there is no one-size-fits-all approach
    • Trust is a key barrier to care for the LGBTQ+ community
    • Patients actively seek LGBTQ+ providers and those trained on LGBTQ+ issues
    • Representing the LGBTQ+ community in research as a driver for participation but diversity quotas are not enough to drive engagement

    There are also considerations of what inclusivity of the full range of LGBTQ+ identities in all aspects of care mean, including:

    • Removing unnecessarily gendered language, imagery, and décor from forms, patient materials and clinical areas
    • Creating inclusive options on multiple-choice forms to account for all LGBTQ+ identities
    • Refining approaches to clinical lines of questioning to ensure sensitivity to LGBTQ+ identities and focus on questions required for care and research
    • Including trusted LGBTQ+ advocacy organizations and local community centers in health and research initiatives

    Diversity is Inherent, Inclusion is a Choice

    Including the LGBTQ+ community in diversity, equity, and inclusion initiatives is not only good for patients, but also valuable, important, and essential for the pharmaceutical and biotechnology industry. When discussing the value of clinical trial participation to the industry, the ratio we all talk about is 1 in 200 – meaning that one in 200 people, regardless of health status, need to participate in clinical research to enroll all the studies in clinical trials.gov at any given time. Allowing barriers to access for any population is not just unethical and bad for science, it's also bad for business. Ensuring diversity, equity and inclusion means more study participants, thorough science, and predictable outcomes for all potential patients.

     

    The path to inclusivity for the LGBTQ+ community is no different from those proposed for the inclusion of other populations underrepresented in clinical research. As Van Johnson suggested in a recent episode of the Totally Clinical podcast and echoed by our LGBTQ+ patient panel, the key to diversity, equity and inclusion is a holistic approach. The way to create a clinical trial environment that is inclusive is to ensure that community members have a seat at the table – LGBTQ+ patients, physicians, advocates, and others. In addition to promoting the diversity in today’s research community, this work will likely involve an expansion to include new investigators, sites and site networks that serve the LGBTQ+ community and enablement of those sites with tools, training, and technologies that can bring them onboard quickly and guide them with consistent, responsive and proactive content and communication.

    As the daughter of a clinical trial participant, it is my intention to play an active role in supporting diversity, equity, and inclusion efforts so that clinical research is a care option available to all patients. If you are a sponsor, investigator, patient, or other stakeholder in clinical research and are advancing a DEI or CRAACO initiative, I invite you to join the conversation on our Totally Clinical industry podcast.

    Malia Lewin

    Life Sciences Strategy Leader

    Guest

    Malia is a senior business strategist with a passion for accelerating new ideas, technologies and innovations within the biopharma industry. In a career spanning over 20 years, Malia has led organizations and spearheaded successful projects from R&D, launch planning and market access through post-market growth strategy, execution and analysis.

    More on LGBTQ+ inclusion in health care

    Industry perspectives
      Industry Report

    Considerations for LGBTQ+ Inclusion in Clinical Research

    Read the findings from an advisory board of LGBTQ+ patients.

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