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Connecting Clinical Research to Communities for Better Health Outcomes

Connecting Clinical Research to Communities for Better Health Outcomes

 

 

In this article, senior Janssen leaders discuss strategies for shaping more diverse, inclusive, and equitable clinical trials.

How many ways might Janssen—and the industry at large—help move the needle for patients through diversity and inclusion in clinical trials? My colleagues and I recently explored possible answers to that question in a panel session, 'The Role of Workforce Leadership and Representation in Inclusive Clinical Trials' at the Women of Color in Pharma's (WOCIP) annual conference, which was held virtually this year.

WOCIP's vision is to enable the transformation of the pharmaceutical industry’s professional landscape for women of color, opening avenues for thought leadership, innovation and connection. I welcomed the opportunity to share insights from my work as both an R&D leader for Janssen and the executive sponsor for our Diversity & Inclusion in Clinical Trials efforts, and was delighted to be joined by senior leaders from across the Janssen family.

Each day in my dual role, I see how shaping our trials to be more diverse, inclusive and equitable can not only strengthen our scientific research and data we collect from each of our trials; ultimately, it has the potential to change the trajectory of disease in all communities we serve.

I'm excited to share here some of the unique insights and solutions that emerged in discussions with my Janssen colleagues. With our collective experience in our respective areas of expertise, we recognize that a collaborative effort is needed to improve diversity and inclusion in clinical trials—and that the urgency of that work is more important than ever, especially for underserved and underrepresented populations. What follows are a few of the needle-moving ways we believe could work best:

Create Partnerships with New and More Diverse Institutions and Physicians

As someone who has championed equitable and inclusive trials for over 25 years, Vanessa Broadhurst believes they are paramount to meeting our promise as an industry to truly serve all populations and all patients. She shared her insights as a strategic leader for Johnson & Johnson’s commercial group and echoed sentiments of our entire panel when she said that as diverse group of people, we desire to be represented in clinical trials—and we recognize it’s going to take change:

“There is a lot of mistrust in the system, for reasons we are very familiar with, but society is changing, medicine has changed, and clinical trials have evolved significantly from 25, 50 years ago,” Vanessa said. “And in a broader sense, it is important that we have the data sets that support the science of ourselves.”

To get there, she emphasized that we must behave differently—at both a community level and as an industry. As a community, we must be willing to participate in clinical trials. And as an industry, we must be willing to conduct clinical trials differently. Vanessa cited Janssen’s GRACE (Gender, Race, And Clinical Experience) study of HIV+ women as an example, and suggested we can think differently about our patient enrollment methods by applying what we did then to what we can do now, including:

  • Looking at different institutions to conduct research
  • Engaging different physicians to conduct research
  • Creating relationships with institutions with diverse populations to develop partnerships that go beyond research

Implementing these changes can help us go beyond one type of study with one type of patient; it can help us study multiple populations and place many different pipeline products at institutions that draw a diverse range of populations that need to be represented.

Start with Internal Teams to Go From Conversation to Concrete Action

Vaccines are one of the most effective tools in preventing infectious diseases, and for vaccines development, diversity is critical: We’re all susceptible, so vaccine trials must be inclusive and diverse. As a physician and head of Janssen’s vaccine development efforts, Macaya Douoguih views diversity and inclusivity in trials through a clinician’s lens.

Macaya shared how critical the concept of representation is to the success of our trials, explaining, “To ensure our product is suitable for everyone, we need safety and efficacy that is both representative and generalizable. There is a history and reasons for mistrust in the clinical trial system, but it is much more regulated now. From my perspective as a person of color, I see good reason to participate in trials as a means of ensuring we are a part of our own solutions.”

Macaya noted that internally, we can start with tough conversations about diversity and inclusion. These discussions were rare in the past, and while we are encouraged that these important conversations are happening today, we cannot stop there. We need to also look at every program we are developing and ask how we are including populations to ensure the indications we have set forth will benefit all.

Macaya discussed Janssen’s important work in Africa, where a key to our success has been to raise up and collaborate with the people who have the cultural competency to help shape our objectives and strategies, understand what can work in a particular setting, and explain how we can be successful.

In the U.S., these same lessons can apply with a two-fold approach: First, we cannot have the same people engaging every community. We must build confidence in diverse communities where we wish to engage by working with people who are trusted by those communities and who are relatable to them.

Second, we must build cultural competency and diversity in our own teams, to strengthen our perspectives as an industry and to successfully meet our own objectives. There is a lot of work to be done, Macaya reiterated, but we can start with making sure our own departments are diverse and have the strongest team possible.

Deliver Patient Education That is Self-Aware and Digestible

Our industry needs to demystify clinical trials, show the public how we have evolved, and explain what protections are now in place for patients. Robin Kumoluyi, who oversees Janssen's quality and safety, has been passionate about the safety and effectiveness of clinical trials for over 30 years.

She shared with us how, as an industry, we can find a way to share that information with patients in manner that is easy to understand: “We can start by cutting down on some of the technical jargon and find simple ways to express to patients what we do, why we do it, how it protects them, and how we ensure they are advocated for during the entire process of a clinical trial.”
 
To help us earn more trust in the clinical trial process, it is incumbent upon us to work with centers and doctors to make it truly transparent why clinical trials are safer than often believed. It is also important that we provide information to diverse communities in a way that answers any questions they may have, addresses any reservations they may have, and is easy to understand.

For example, we can share a simple explanation of the purpose behind clinical trials: to ensure medicines on the market are safe and effective for populations who will use these medicines once they are approved. By including people of color in clinical trials, we assure the variations in response due to genetic factors are detected.

The Way Forward

Our panelists recognized the pharmaceutical industry is not always the most trusted voice in the room. However, transparency can go a very long way in engendering trust. It is important we continue to be transparent and responsible with our data, strive to create platforms strategies and partnerships for the long-term with all of the populations that we serve, and do this together, as a team, at all levels.

To learn more about Janssen, our team and the latest technologies and innovations we are championing, visit the Janssen Clinical Innovation section of our website.