The Critical Role of Diversity, Equity, and Inclusion in Clinical Trials
Clinical research has impacted your life, even if you haven’t been aware of it. For anything from life-saving medical technologies to products like sunscreen, you have clinical trials to thank. Trials help to ensure the safety and efficacy profiles of the FDA-approved products and treatments we use, offer hope for cures to debilitating diseases, and are an essential component of healthcare. The reality is this—for patients worldwide, clinical trials aren’t just a nice-to-have, they’re a need-to-have. And clinical trials need people.
While certain aspects of health are advancing, some people continue to be left behind. There is an abundance of evidence showing that factors like gender, race, ethnicity, age, or co-morbidities can cause disease to strike groups differently. These factors can also determine if a medicine or therapy is safe and effective for a particular group. For this reason, all groups must be represented in clinical research so that investigational medicines can be studied across different patient populations. Yet, major gaps still exist. In fact, a recent study of trials involving 150,000 patients in 29 countries over the past 21 years showed that the ethnic makeup of the trials was about 86% White.1
The reasons for these disparities are varied and complex. Underrepresented groups may feel a lack of trust in the clinical research process, may not be aware of the participation options available, and may experience logistical challenges. These barriers may include transportation costs and financial implications from taking time off work to participate.
The good news is that these disparities have come to the forefront, and rectifying them and promoting better diversity, equity and inclusion (DE&I) in clinical research has become a major focus for the healthcare industry. The Janssen Pharmaceutical Companies of Johnson & Johnson has been prioritizing DE&I in clinical trials for some time, with the goal to build a future of equity in healthcare.
Janssen’s DE&I in Clinical Trials team began operating in 2018 as a strategic initiative to shape the future of clinical research across all of the therapeutic areas where Janssen focuses. Team members believe that clinical trials are ultimately about relationships—and that strategic collaborations with investigators, physicians, and key stakeholders can help them effectively communicate the value of clinical research to potential trial participants. Their work centers around meeting the needs of their partners, easing barriers to access to clinical trials and streamlining the experience for all involved parties.
When asked about how Janssen can make an impact in this area, Associate Director of Diversity & Inclusion in Clinical Trials, Ramona Burress, shared, “We need to transparently communicate to patients and communities what to expect and what not to expect when participating in clinical research, how they are protected and why their participation is so crucial in the development of treatments. We hope to continue to build meaningful trust with patient communities and create diverse clinical trials for investigational drugs that may serve the needs of all patients who may need them.”
Having open and honest conversations about health equity is an integral part of understanding and removing the barriers to participation so that actionable, tangible solutions can be created. Janssen continues to work to better acknowledge, recognize and address the barriers preventing clinical trial participation for underserved and underrepresented populations who may face fear, mistrust, lack of awareness of the options available, and logistical challenges.
Among other areas across its portfolio, Janssen is leading the charge in research in immune-mediated diseases, which are so often distressing and debilitating for the patients who face them, and which traditionally have presented patients with limited treatment options. Patients living with an immunological condition such as ulcerative colitis, hidradenitis suppurativa and rheumatoid arthritis, among others, who would like to contribute to more equitable and inclusive research, can visit the Janssen Global Trial Finder and learn more about the Company’s commitment to diversity on their Research Includes Me website.
By putting a focus on relationships first in clinical research, Janssen is working to reduce barriers and increase participation for historically underrepresented and underserved groups, including in disease areas like immunology where there historically have been unmet patient needs and few or no advanced treatment options for a number of chronic autoimmune conditions, such as lupus, Sjögren’s syndrome, and hidradenitis suppurativa. People need all kinds of clinical research. Clinical research needs all kinds of people. With a focus on diversity, equity and inclusion driving its approach to clinical research, Janssen is creating an industry-leading impact for all the patients and sites they serve.
1Editors T. Clinical trials have far too little racial and ethnic diversity. Scientific American. https://www.scientificamerican.com/article/clinical-trials-have-far-too-little-racial-and-ethnic-diversity/. Published September 1, 2018. Accessed October 2021.