In line with Our Credo values, our commitment to health equity, and the ORTHE mission, Johnson & Johnson has made DEI in clinical trials a priority. Our ultimate goal is to create transformational therapies that work for all patients, which requires that everyone has the opportunity to participate in clinical research, if it is right for their treatment journey. This is an important step on our journey to achieving global health equity.

In 2022, our Janssen DEI in Clinical Trials (DEICT) team created a clinical trial diversity plan template to embed into the clinical trial process. In addition to working cross-functionally to ensure the plan is inclusive of all Janssen therapeutic areas, the template strives to include diversity factors like gender, sexual orientation and socio-economic factors, in addition to race and ethnicity. Janssen is proud to have been one of the first organizations to proactively submit a diversity plan to the FDA for an oncology trial, well ahead of the regulatory body’s new guidance on initiatives to expand action and disclosure on clinical trial diversity. To turn plans into action, the plan template also includes strategies and tactics for improving equitable representation in clinical trials.

Did you know?

More than 40% of 230 U.S.-based clinical trials did not report the race of participants, and almost 65% did not report ethnicity. Of those that did report race, 78% of participants were white, while just 11% were Black, 6% were Asian and less than 1% were Native American. In studies reporting ethnicity, only 11% of participants were reported as Hispanic or Latin.2

Improving representation requires removing the core barriers to inclusion for traditionally underserved and underrepresented communities, which is the primary focus of Janssen’s Research Includes Me initiative. This initiative aims to meet communities where they are with educational materials, connect patients to current trials, and partner with advocacy groups to understand traditionally underrepresented and underserved communities’ needs. Additionally, the initiative aims to build trust in the safety of clinical trials and the healthcare system overall. For example, to coincide with Hispanic Heritage Month, DEICT brought attention to health disparities facing the Hispanic/Latino community in the U.S. with a robust, dual-language campaign to communicate the importance of participating in clinical trials and boosting awareness of resources available through Research Includes Me.

Janssen is also breaking down barriers to equity and inclusion by leveraging digital-health technology to bring trials to patients like never before. Decentralized clinical trials use communications and digital-health technologies to better connect to trial participants, avoiding the need for them to visit a clinic. This opens up opportunities to reach patients in remote or underserved areas for inclusive representation at unprecedented levels. We are actively pursuing decentralized trial options across our entire development pipeline.

Additionally, Janssen is investing in the current and next generation of healthcare professionals, with the understanding that communities want healthcare professionals who look like them, speak the same language and understand the cultural nuances required for holistic medical care. For example, Janssen joined forces with the Children’s Mercy Research Institute to create a six-week, hands-on, high-quality summer research experience called the Children’s Mercy STAR (Summer Training in Academic Research) Highschool Program for high school students and teachers from underserved communities who identify as belonging to a racial/ethnic background, underrepresented in science and medicine. Similarly, the Oncology High School Outreach program introduces young talent from underrepresented groups to drug discovery and development fields by providing mentorship and exposure for high school students to research, drug development and healthcare careers.

To advance health equity for all patients, it’s critical that we act with urgency to continue to embed DEI best practices in our study designs. To support and guide the organization, the DEICT team has launched four workstreams addressing diversity planning, training in clinical trials processes, metrics tracking and informed strategies for a customized approach to embedding DEI in clinical trials outside the U.S.

Staci Hargraves

Vice President, Patient and Portfolio Solutions and Head of DEICT, Janssen

In 2022, we enhanced clinical trial diversity via:

  • Improving representation in cancer clinical trials in Africa through collaboration with the African Access Initiative (AAI) supporting access to cancer care in 10 hospitals in five African countries, patient education programs and training for more than 2,000 healthcare professionals on cancer diagnosis and treatment.
  • Sponsoring Color of Crohn’s and Chronic Illness (COCCI) to help raise awareness of inflammatory bowel disease (IBD) among BIPOC communities and advancing inclusive clinical research.
  • Launching a trial to study plaque psoriasis in BIPOC in a first-of-its-kind clinical study, VISIBLE, which is 100% dedicated to Black, Hispanic, Asian, Indigenous and other people of color living with plaque psoriasis.
  • Understanding how lupus affects Women of Color through our collaboration with the Latin American Group for the Study of Lupus in Latin American populations.
  • Increasing inclusion in multiple myeloma studies through our initiative with Mount Sinai Medical Center in New York City to support a multiple myeloma clinical research network.

Changing the Dynamics of Inclusion in Digital Health Trials

Biosense Webster, a J&J MedTech company, and Johnson & Johnson Clinical Operations partnered with Acclinate—a digital health company integrating culture and technology to source diverse participants for clinical trials—to change the dynamics of inclusion in clinical trials. Using Acclinate’s app, NowIncluded, stories of people with medical conditions are used to encourage people in communities of color to participate in clinical trials.

Advancing DEI in MedTech R&D


J&J MedTech is also taking steps to enhance racial and ethnic diversity among clinical trial participants; reduce barriers to clinical trial participation; enhance community engagement; and build capacity for change among community leaders, providers, and trial sponsors with the goal of improving meaningful representation in clinical studies leading to better products and better outcomes. In 2022, J&J MedTech drove internal awareness and capabilities across the business through reviews of diversity in past and current clinical trials to provide insights for improvement, hosting internal workshops for relevant staff to build capabilities and leveraging new real-world evidence in clinical study design.

Additionally, in 2022, the team co-created policy positioning on diversity in research and clinical trials in the U.S. to inform advocacy for policy priorities that reduce barriers to participation and enhance equity. J&J MedTech continued to support the Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trial Act and brought together experts at the AdvaMed MedTech Conference for a review of the challenges in underrepresentation and inclusion in clinical research and define actions to ensure all patients benefit from safe, effective, and innovative medical technologies and that the broader clinical ecosystem is further diversified with more diverse clinical trial investigators and site staff. As part of the AdvaMed Advancing Health Equity Through MedTech workstream, the teams collaborated on a white paper on approaches to increasing diversity in clinical research and led a Congressional roundtable on the industry’s role in responding to health disparities.