By Lisa Lewis, MPH, director, diversity, equity, & inclusion in clinical trials – oncology, Janssen Research & Development
The pharmaceutical industry continuously works to address the unmet needs of patients, including the need for therapies that work for as many people as possible. Yet, we continue to see a lack of diversity in clinical trials. In 2019, among clinical trials for 11 new drugs, 73% of participants were white, 4% were Black or African American, and 5% were Hispanic.1 Today, each pharmaceutical and biotech company, academic institution, healthcare professional, and community group has a different approach to tackling this issue. But the reality is, it will require all of us, working together, to help reduce the growing mistrust of the healthcare industry and dismantle the systemic barriers that limit underrepresented, underserved, and marginalized communities’ participation in clinical trials.
Who Should Be Included in Clinical Trials?
Representation in clinical trials helps ensure research results are representative of the patients who may be administered the medicines being studied, if approved. As we seek a world in which health equity is the norm, inclusive clinical trials are one critical step in the journey.
It is important to note demographics go beyond just race and ethnicity. As we think about engaging underrepresented communities, we must also consider other factors such as sex, gender, sexual orientation, age, geographic location, language, and socioeconomic status, among others.2 For example, research conducted by the NIH to determine barriers to cancer clinical trial enrollment included focus groups in which patients identified distance to trial sites and language as significant barriers to their participation and trust in clinical trials.1 Including patients in clinical trials that mirror the population that needs them is crucial. This is an ongoing effort with incremental lessons learned along the way, and we must apply our learnings as we go to continuously broaden our focus and improve our approach.
When it comes to race, trial enrollment goals were historically set using U.S. census data. Setting aside known limitations in how U.S. census data has historically been captured, particularly among communities of color, this data does not tell the full story. We must go beyond traditional goal-setting methods and use novel interdisciplinary analytical approaches, such as epidemiologic data, real-world evidence, and data science tools to understand how certain populations are impacted by a disease and establish enrollment goals that align with real-world needs across disease areas.
While actively and sustainably embedding diversity, equity, and inclusion in clinical trials is important across disease states, there are some diseases that disproportionately impact populations that were historically and are currently underrepresented in clinical trials. It is with these communities and in these disease areas that we must double down on our efforts to increase awareness about the importance of diversity in clinical trials. Oncology is one such area. Among U.S.-based patients that received a cancer diagnosis between 2001 and 2018, those who identified as either Black or American Indian/Alaska Native had the highest overall death rates (221.4 and 193.2 per 100,000 males, and 152.1 and 138.1 per 100,000 females, respectively)3. To combat this disparity, Janssen works closely with key groups, such as the American Cancer Society and Stand Up to Cancer, to promote and increase awareness of participation barriers often faced by underrepresented groups. We work together to break down such barriers to advance diversity in clinical research and positively impact various communities.
The American Society of Clinical Oncology and the Association of Community Cancer Centers recently released a joint statement that presents specific strategies for the research community to improve diversity, equity, and inclusion in oncology trials. These recommendations acknowledge that the availability of clinical trials is an integral component of high-quality cancer care. Every person with cancer should be aware of available clinical trials opportunities, and all patients should have the opportunity to participate should they meet the required criteria. Clinical trial sponsors and investigators should have inclusion in mind from study development to implementation to increase participation of underrepresented groups.4
What’s Stopping Us? Understanding The Barriers For Underrepresented Groups
Many factors play a role in the consistent lack of diversity in clinical trials, including lack of awareness, inadequate educational resources for patients and physicians, logistical concerns, and financial barriers.5 Another important barrier for underrepresented, underserved, and marginalized communities is trust.
Patients from these communities often have a lack of trust in healthcare systems in which they are not adequately and consistently considered; couple that with a lack of awareness of clinical trials, prevalent misinformation about clinical research, and disparities in access to trials, and the current lack of trust is easily understood.
Many patients and those in their care communities are not made aware of existing clinical trials, let alone how to access them.6 Even when patients do have clinical trial information, and they meet the qualifications, they may be reluctant to participate because of a lack of sufficient information to adequately assess the potential benefits and risks of trial participation.6 Additionally, infrequent visits, language barriers, and misunderstood cultural nuances between patients and providers are significant contributors, as is the fact that clinical trial materials are often provided in English and not translated into the languages spoken by patients in these communities.7 Of the more than 14,000 clinical trials registered on ClinicalTrials.gov between 2019 and 2020, just 2.7% specifically mentioned translation of materials into a language other than English.7
Beyond the barriers prior to clinical trial enrollment, those who do choose to participate in trials often face additional barriers, including transportation, lodging, scheduling, family-care logistics, and the general burden it may place on the patient and their support system.2
How Can We Do Better? Steps For Improving Inclusion
Doing better requires a two-pronged approach. First, the industry must do more to operationalize and standardize its approach to embedding diversity in clinical trials, from protocol development and site selection to plans and strategies for recruitment, enrollment, retention, and reporting. Second, as pharmaceutical and biotech industry leaders, we must actively engage groups that are historically and currently underrepresented in clinical research through purposeful, intentional, and sustainable approaches in order to build trust. This can be achieved through robust collaboration with organizations that already have the trust of the communities we want to reach (like advocacy groups and community organizations), increased clinical trial awareness and education efforts, collaborating with investigators and healthcare professionals who have diverse cultural understandings, and investing in digital health solutions to improve trial accessibility. The DEICT Oncology team had the opportunity to build visibility and trust with underrepresented communities through our partnership with Black Health Matters on an educational session during their Spring Health Summit, where we provided information about multiple myeloma (MM) and the importance of community-based clinical trials. The team also recently launched a colorectal cancer disease and clinical trial awareness campaign for the ORIGAMI-1 Study (Amivantamab) with Black Health Matters.
The FDA has recently acknowledged the need for increased progress in this area. The recent Food and Drug Omnibus Reform Act (FDORA) outlines the need for greater diversity in clinical trials and requires “diversity action plans.” Applicable to the most pivotal trials, the requirement takes effect after the FDA issues final guidance on the format and content of the plans. At Janssen, we take great pride in being one of the first pharmaceutical companies to proactively submit diversity plans to the FDA for oncology trials conducted in the U.S. The FDA has previously issued several sets of recommendations to improve clinical trial diversity, including collecting demographic data and broadening eligibility criteria when scientifically appropriate. FDA guidance also acknowledges that other stakeholders have recommended operational plans to increase diversity, which might include offering financial reimbursement for participation, providing translations, and supporting language-inclusive environments, and partnering with advocacy groups and community organizations to support trial participants.2
Ensuring diversity and inclusion in clinical trials requires a focus on participant enrollment but also includes having healthcare professionals who are equipped to conduct clinical trials and who understand the specific cultures, needs, and concerns of diverse populations. This includes equipping healthcare professionals to discuss key elements of trial participation and ensuring patients can receive communications in their preferred language. Janssen is investing in the next generation of future clinicians and researchers from racially and ethnically diverse backgrounds to help build a diverse healthcare workforce that is representative of the patients they treat. One example is Janssen’s Scholars of Oncology Diversity Engagement Program (SODEP) program, which aims to build relationships with Ph.D., PharmD and medical students, as well as post-doctoral researchers, by providing visibility to our job opportunities by providing industry exposure and mentorship from our senior R&D leaders at Janssen.
Similarly, we must find new ways to make clinical trials more accessible to people who may not be able to regularly travel to a trial site. Conducting clinical trials not only at large academic medical centers but also at community-based hospitals and care centers, as well as utilizing decentralized trial modalities and digital health technology, will enable more geographic diversity in clinical trials. This is particularly important in the oncology space, where patients often travel to large academic medical centers and need extensive and frequent care beyond what is required as part of trials. Janssen recognizes this barrier and has funded an initiative with Mount Sinai Medical Center in New York to support a multiple myeloma clinical research network, which served to support the medical center’s efforts to increase accessibility to multiple myeloma clinical trials at multiple locations.
The key message is this: We must put the patient at the center of everything we do. We must respect and understand the needs of patients from a variety of backgrounds and build a clinical trial ecosystem that not only supports but promotes diversity, equity, and inclusion, from physician visits to pre-trial planning and site selection to results reporting. The decision to enroll in a clinical trial is significant, and we must do all we can to remove barriers and ensure that all patients are aware of and have access to clinical trials.
As an industry, if we are truly committed to health equity, it is our responsibility to conduct research that is diverse, equitable, and inclusive of all patients, with the ultimate goal of providing treatments and therapies that have the potential to work for everyone. The only way to achieve this is by ensuring that clinical trials are truly representative of the populations that will ultimately use these medications, with a sustained effort and investment to make clinical trials available to all.
- Barriers for Cancer Clinical Trial Enrollment. NIH. Published May 2022.
- Food and Drug Administration (FDA). Diversity plans to improve enrollment of participants from underrepresented racial and ethnic populations in clinical trials; draft guidance for industry; Availability. Draft Guidance for Industry. Published April 2022
- Cronin KA, Scott S, Firth AU, et al. Annual report to the nation on the status of cancer, part 1: National cancer statistics. Cancer. 2022;128(24):4251-4284. doi:10.1002/cncr.34479
- Oyer RA, Hurley P, Boehmer L, et al. Increasing racial and ethnic diversity in cancer clinical trials: an American Society of Clinical Oncology and Association of Community Cancer Centers joint research statement. J Clin Oncol. 2022;40(19):2163-2171. doi:10.1200/JCO.22.00754
- Nipp RD, Hong K, Paskett ED. Overcoming barriers to clinical trial enrollment. Am Soc Clin Oncol Educ Book. 2019;39:105-114. doi:10.1200/EDBK_243729
- Wong AR, Sun V, George K, et al. Barriers to Participation in Therapeutic Clinical Trials as Perceived by Community Oncologists. JCO Oncol Pract. 2020;16(9):e849-e858. doi: 10.1200/JOP.19.00662.
- Muthukumar AV, Morrell W, Bierer BE. Evaluating the frequency of English language requirements in clinical trial eligibility criteria: A systematic analysis using ClinicalTrials.gov PLoS Med. 2021 Sep 14;18(9):e1003758. doi: 10.1371/journal.pmed.1003758.
About The Author:
Lisa Lewis, MPH, is the director of diversity, equity, and inclusion in clinical trials – onocology at Janssen Research & Development. As a member of the Janssen Diversity, Equity and Inclusion in Clinical Trials (DEICT) team, Lisa has the primary responsibility of collaborating with leaders and managing the Janssen Oncology D&I in Clinical Trials internal steering committee and cross-functional working groups. She works closely with the DEICT Oncology team and key stakeholders in the oncology therapeutic area to develop and implement diversity and inclusion strategies and diversity plans for Janssen company-sponsored studies, ensuring participants included in Janssen Oncology trials more closely represent the real-world patient population.
Lisa has represented Janssen at key conferences and symposiums and has been featured in top pharmaceutical industry publications. With nearly 25 years of experience in oncology, Lisa received her Bachelor of Science in biology (pre-medicine) from Stony Brook University, Master of Public Health with a concentration in health informatics from New York Medical College, and will begin her Master of Science in bioethics at The Harvard Medical School Center for Bioethics in fall 2023.