Hear from Dr. Otis Johnson, Co-Founder of Trial Equity Group, as we explore the critical issue of patient diversity in clinical trials. Dr. Johnson discusses the alarming underrepresentation revealed in recent research, and shares how Trial Equity is addressing this gap. Join the conversation to uncover the impact of diverse recruitment on trial efficiency, the positive trends in technology, and the future of inclusive clinical research.
Hear from Dr. Otis Johnson, Co-Founder of Trial Equity Group, as we explore the critical issue of patient diversity in clinical trials. Dr. Johnson discusses the alarming underrepresentation revealed in recent research, and shares how Trial Equity is addressing this gap. Join the conversation to uncover the impact of diverse recruitment on trial efficiency, the positive trends in technology, and the future of inclusive clinical research.
Welcome and thank you for joining the Society for Clinical Research Sites for SCRS Talks. I'm Jimmy Bechtel, the Vice President of Site Engagement with the Society. SCRS Talks allows our partners and those that we work closely with to take a few minutes to address issues of industry concern, share exciting achievements, and to learn more about our extensive community. Today, we have Dr. Otis
Johnson, the Co-Founder and
Jimmy Bechtel:Principal Consultant at the Trial Equity Group here to share more with us about how his organization is paving the way for equitable access to clinical trials. Dr. Johnson, it's great to have you with us. Really excited to be talking with you about this critical. Really this critical information, this critical topic for our industry. If you wouldn't mind, I'd love to start things off and learn a little bit more about you and your background.
Otis Johnson:Yeah, thanks for the opportunity, Jimmy. And thanks for the nice introduction. Now, I have been working in clinical trials for two decades in various scientific technology and operational roles. Now, that's all of my working career. So I would like to know that those treatments that I helped develop will work for me and my close family and friends when we need them. But I know that quite often that will not be the case because of the lack of patient diversity in clinical trials. Just imagine your loved one taking an approved medication for a life threatening condition, but you're not sure if it's going to work because it wasn't tested in enough people like you. That is the reality for many. And Tufts Center for the Study of Drug Development describes it as a dangerous underrepresentation in clinical trials. Now, after spending 13 years at Merck in scientific and operational roles, I led feasibility and clinical informatics functions at Seniors Health, then at ICON, before moving on to Clario. In my role as Chief Diversity, Inclusion and Sustainability Officer at Clario, I focused on advancing DEI and sustainability practices, and this included commitments to pay equity, increasing representation of people of color, and pursuing gender balance in leadership position. I was recognized as a former voice 100 most inspiring industry leader and a top DEI leader by Mogul. And most recently, I was awarded the healthcare business women's associations 2024 honorable Mentor Award. Now, my involvement with the HBA as a Global Advisory Board member has been a significant part of my journey, emphasizing my dedication to promoting diversity in the healthcare sector, both in clinical trials and in the clinical trial workforce. Now, in my current role, As co founder and principal consultant at Trial Equity, I am passionately working to ensure more representative patient populations are enrolled in clinical trials. Now, this is vital to ensure that the medicines are safe and effective for all people. And by focusing, on equipping clinical research professionals with the necessary knowledge and skills to achieve this goal. We are essentially addressing a critical gap in the healthcare industry. So I have an e-learning course with tips on how to speak about clinical trials with people from various backgrounds in a way that they do not feel offended and will be more likely to consider clinical trials as an option.
Jimmy Bechtel:That's great, Dr. Johnson. It sounds like your career path has been very aligned with this topic, obviously, and really interesting. I know we're going to talk a little bit more about some specifics in the work that you do now, but I'd like to kind of take a step back and get a picture for our audience here. You know, everyone has an idea and some input, but I'd love to hear your perspective on what the current landscape of patient diversity is in our clinical trials and maybe a little bit about where the industry is succeeding and where it might be falling short, representing some of those diverse patient populations.
Otis Johnson:Yeah, excellent, excellent question. It's always good to set the stage. And to do that, I actually want to incorporate some recent research into the discussion about the current state of patient diversity and inclusion in clinical trials because it adds an important dimension. And this is research that I was personally involved in. So in this study that I co-authored with Tufts Center for the Study of Drug Development and Clario, we analyzed 1, 165 pivotal trials that supported FDA approved drugs from 2007 to 2021. Our findings received a stark underrepresentation. Blacks were underrepresented by 64 percent in those trials. Hispanics by 32 percent and Asians by 32%. Now, this data clearly indicates a significant gap in the inclusion of diverse populations in clinical trials. The under representation of these groups raises concerns about the effectiveness and applicability of medical treatments across diverse populations, and that is a key issue in the healthcare industry today. Now, one particularly striking finding from our research was that as black representation in trials increased, the duration of those trials decreased. This suggests that increased diversity in clinical trials does not only fulfill an ethical and social imperative, but can also lead to more efficient research processes. And this efficiency aspect challenges some common misconceptions about the feasibility on logistics of conducting more inclusive clinical trials. Some people actually believe that it delays the clinical trials. But this research is saying the opposite that that, in fact, is not the case. So while the industry is making progress in recognizing the need for diversity and representation, our research underscores the urgency and benefits of accelerating these efforts. It's clear that there's a long way to go in ensuring that clinical trials are truly representative of the populations they aim to serve. This isn't just a matter of equity, it's about enhancing the quality and effectiveness of healthcare for everyone.
Jimmy Bechtel:Dr. Johnson, whenever we hear statistics like that, it's, it is staggering to understand exactly what's going on in the industry when it comes to our work in DE& I. We still have so much work and progress to do. We'll, we'll talk a little bit more about the direction that we're heading, which I think is positive. And great to see that we are moving things in the right way, but it's always interesting to hear updated statistics on exactly where we stand with our ability to recruit underrepresented patient populations into our clinical trials.
Otis Johnson:Indeed, indeed. And and the story is more positive. I just chose to highlight a statistically significant finding. But in general, the more diverse the patient population that was recruited in that trial, the lower the recruitment duration tend to be. It just happens to be that that particular metric for black participants was statistically significant.
Jimmy Bechtel:That's excellent. Yeah, that's that's good, right? It's the silver lining there. Like I talked about with the the data and the direction we're heading, I think, is always important for us to highlights. But Dr Johnson, we talk a lot now, especially in recent years ever since truly ever since we've crawled out of the challenges. Most of them related to the pandemic around technology and how we can use technology to help us improve our diversity in clinical trials. So I'd love to get your perspective and thoughts on how technology can contribute to improving some of those diversity metrics as it relates to clinical trial engagement.
Otis Johnson:Absolutely. I've always said that technology has to has the potential to be the great equalizer and to create equity in clinical trial participation and subsequently for those who will benefit from the medications that result. I'd like to get a little bit more specific here because people tend to throw technology around a lot. And I would like to highlight a few components that can help enhance recruitment strategies, training and patient engagement. Now the two examples I want to highlight are innovative e-learning courses for clinical research professionals and advanced tools for patient pre screening and engagement. Now e-learning platforms like Trial Equity's clinical trial diversity course, plays a critical role. This type of training equips clinical research professionals with the knowledge and skills necessary to enroll more representative patient populations. By understanding the barriers to participation faced by diverse groups and learning strategies to overcome these challenges and address myths, professionals can conduct trials that are more inclusive. Now, these e-learning courses provide an accessible way for professionals to stay informed about best practices in patient recruitment and engagement. Now, the second technology I would like to highlight is technology like Binah.ai. They offer promising solutions for improving the processes of pre screening patients. Now, Binah.ai's facial scan technology significantly streamlines the prescreening process for clinical trial patients. It uses a non invasive, efficient approach by analyzing a patient's facial features through a simple video selfie, and provides real time health metrics like heart rate, blood pressure, and stress levels. This method enhances the accessibility and comfort for potential participants. Especially those from diverse backgrounds by enabling remote screening. Now, the technology's ability to accurately collect vital health data without physical clinic visits makes it a powerful tool in increasing participant diversity and improving the overall quality of clinical trial recruitment. So technology through specialized training platforms and advanced pre-screening tools offers a pathway to address some of the longstanding issues of lack of diversity in clinical trials. It hits on data collection, patient pre screening, and then just making sure that people understand how to talk to people from different backgrounds.
Jimmy Bechtel:Thanks, Dr. Johnson. I think the concept of artificial intelligence, AI, and its role that it will play in our ability to find and recruit diverse patient populations in, of course, safe and ethical privacy be considerable ways is really, really interesting. I think there's a lot of opportunity there, especially from a patient recruitment perspective. So thank you for sharing that example specifically Dr. Johnson, what practical advice can you offer to our clinical research sites that SCRS has such an extensive reach into and our industry partners on creating and implementing effective diversity plans really thinking about it from that initial planning stage all the way through execution. We want to be able to prioritize inclusivity. So maybe if you could provide some thoughts there from your very broad perspective, that would be great for our audience.
Otis Johnson:Yeah, absolutely. And I know there's a lot of focus on the need for these diversity plan now, which is a great step by the way. And I like the fact that you're focused on putting those plans into action. We cannot just keep talking at a high conceptual level. We have to focus on how we make those plans real and make them meaningful. And I would say the first place we have to start is that we have to do some introspection. We need to know and understand the state of diversity in our clinical trials. So we must conduct a thorough assessment of the current Diversity levels. And this will be the baseline because once you get to the point of implementation, you need to know if you're running more diverse and inclusive trials. So I would say the first advice to sponsors and the CROs is to really understand the state of diversity in the clinical trials that they're involved in. So that they will know when their actions are actually delivering results. And these goals that you set once you understand the state of affairs, they should not be abstract. There should be numbers associated with them. They should be tangible and treated just like any other scientific or operational goals with measurable metrics. And then training and education is key. So it's important to provide comprehensive training for staff. They need to understand the importance of diversity in clinical trials and the implications. In my introduction, I talked about an example where you may have a family member who needs to take a drug. If those trials that supported the approval of those drugs were not diverse, then you have to worry. So it's important for the clinical trial workforce to have that type of understanding so they understand why they're taking steps to make trials more diverse and inclusive. And that's why training is so important. And then the next step is around inclusive marketing approach. So whenever there's a need to conduct outreach to potential trial participants you must ensure that your marketing and outreach materials speak to diverse population. This step is about understanding and respecting cultural nuances and using multiple channels with culturally sensitive messaging to reach a broader audience. So it's not just about speaking. It's about being heard. So you have to make sure that your messaging resonates. And then the other thing I want to highlight is the importance of reporting and transparency. Because transparency is one of those things that breeds trust. Now, you need to regularly report on your diversity metrics to your key stakeholders. Maintain an open dialogue about the efforts and challenges in achieving diversity goals. Now, one thing I always say is that diversity is hard. So you can't be discouraged when you're not getting the results that you seek immediately. You have to keep at it. And it's not just about having reports. You need to engage in whether it's quarterly reviews or whatever frequently you choose. You need to engage frequently and recalibrate as necessary, and this step is about keeping diversity top of mind and fostering a competitive spirit among colleagues and service provider to exceed your own benchmarks. And then the last thing I'll say on this topic is around inclusive protocol design because you mentioned what can you do from the beginning to the end from the initial steps. So protocol design is really where it starts. Every aspect of your clinical trial protocol should be examined through the lens of inclusion. Ask yourself, does this design inadvertently exclude certain groups? I mean, I have examples of that during my protocol design days at Merck. And are we accommodating the diverse needs of potential participants? So creating a diversity plan is not just a procedural necessity. It's a commitment to excellence and equity in clinical research. It's about building bridges across cultural divides and ensuring that everyone has a voice. So by following these steps, you can ensure that inclusion is not just prioritized. But ingrained in every step of your journey.
Jimmy Bechtel:Wow, Dr. Johnson, it's really great to hear so many different aspects of really building, like you said, which I think is such an important concept, building this concept of diversity and inclusivity. into how we go about executing our clinical trials, both at the site level and at the industry level is so important. It's not just one particular aspect or one particular consideration or approach that we need to employ here. It's training, it's data, it's follow up, it's metrics, it's transparency. And I think that message is one that's really, really important. And I think it's great that you shared so many different things for us as an industry to kind of consider and almost start to build a checklist with as we're approaching our clinical trials going forward. Dr. Johnson, we're going to begin to wrap our conversation up here. I do have a final question for you. What do you foresee as the future of trends and development in ensuring diversity, equity, inclusion in our clinical trials? And part of that being then how the industry can continue to evolve to address those challenges and really truly make progress in this important and critical area of clinical trial execution.
Otis Johnson:Yeah, thank thank you for that question. That's important. I'm only going to highlight a few trends and developments that that I see for the future of diversity in clinical trials. I think 1 of the 1st things that you're going to see is that regulatory bodies like the FDA may implement stricter guidelines and requirements for diversity in clinical trials. A lot of companies are taking a wait and see approach. And they're waiting to see more coming from agencies like the FDA. And I, and I think it's coming. And this would compel pharmaceutical companies and research organizations to prioritize DEI in their study designs and recruitment strategies. Eventually, there will be incentives such as priority review and consequences such as post marketing commitments and delayed approvals. So to avoid these potential future consequences, I mean, I would advise the industry to start doing what you can now to make your trials more diverse and inclusive. And then I think the second thing you're going to see is the use of our artificial intelligence and advanced data analytics will become more prevalent in identifying and recruiting diverse trial participants. We've already seen a lot of that, and we're just going to see a lot more where technologies like machine-learning can analyze vast data sets to uncover insights about underrepresented groups and improve targeted outreach. But I always want to caution the use of AI in this way because care must be taking when using these types of techniques to support clinical trials, because if you use bias data to train the models, you will get bias results and perpetuate the clinical trial diversity problem. So we have to be careful with the explosion of AI to find patients for clinical trials.
Jimmy Bechtel:Well, Dr. Johnson, that's a really great message. And a great place for us to begin to conclude our conversation. At least I think it's a positive note and some really exciting advancements coming down the pipe for us to think about and pay attention to and consider. Any other thoughts or concluding positions that you'd like to offer our audience.
Otis Johnson:Yeah, just just very quickly. I mean, we've had a good discussion. And I would say to effectively address the trends and developments in clinical trial diversity that we've been discussing, the industry will need to be proactive, flexible and committed to embedding DEI principles at every level of clinical research. the spotlight on clinical trial diversity and supporting actions have put us on a path of no return. Regulatory agencies are getting more involved and more aggressive in helping to solve these problems. But we must keep the spotlight on the problem and continue to use strong language to articulate the extent of the issue and how dangerous it is. So I just want to thank you for the opportunity, Jimmy. It was a pleasure to talk with you.
Jimmy Bechtel:Thank you, Dr. Johnson. And for those that are listening, make sure that you register for upcoming summits like the Include Site Solutions Summit being held throughout the year by visiting the summit page on our website, myscrs.org. While you're on our website, be sure to also check out the other SCRS publications and resources built for our community in the publication section of that same website. We appreciate your participation and listening to today's program and look forward to having you join us for more great content coming out soon. Thanks again for listening.