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From May 2022 through December 2023 I worked with a pharma sponsor helping to enhance diversity in their clinical trials. Due to the contractual arrangement I was unable to post or blog or otherwise discuss the work I was doing. As a result, I have not posted here for quite a while. As we were making progress and making change I thought, for sure, that progress was also being made industry-wide. I thought I missed the boat to continue to support the industry. I was sooooo wrong! Over those 18 months I got to know one sponsor pretty well. Since leaving that sponsor I have had several opportunities to see behind the curtain of several other sponsors. Every company is struggling with direction, the strategy to take. In the Drug Information Association DEI in Life Sciences Community we have come to this conclusion – companies need more direction. We are not going to get blanket direction from the FDA, we need to collaborate to continue to evolve in this space. We need to share the lessons learned, mistakes made.  The DIA DEI in Life Sciences Community wants to be that safe space to collaborate. Follow this link to the event page on this site and download the meeting to your calendar – There is much work to do. We need to be sure everyone understands what community engagement means. We need to be sure everyone understands the resources and suppliers with whom we can work to get this done. We need to promote the change in thinking that will make room for real diversity in clinical trials. We can collaborate without sharing proprietary information from each of our companies. I look forward to working with you to continue the evolution of change in this space. My Inspired Thoughts, Dyan Bryson

This is the first of a series of posts planned over the next few weeks. At the end of April, I finally attended my first in-person industry meeting in two years. I had the honor of presenting at the DTC National meeting during the Multicultural Health track, held in Boston. The next week I went to Philly to attend the Patients as Partners meeting. At each meeting almost every speaker, including me, opened with being grateful for being in person, seeing a live audience.  The message thread through both meetings was the incredible evolution that is finally taking place in the life sciences industry. What I had been sensing in my gut was proven to be true – the life sciences industry - provoked by COVID and the death of George Floyd - is finally embracing: what it will take to improve how it engages with patients/people,  that it is willing to do the work it takes to ensure that clinical trials are diverse,  technology will help propel the industry on, at least, these fronts I am part of ongoing efforts to address these issues with the Digital Medicine Society (DiME), the Drug Information Association (DIA) and Patient Centered Outcomes Research Institute (PCORI). All of this activity is due to the momentum in the industry. All of these efforts are supported by people, like me, who have been pushing the industry for, at least, the last 15 years.  While it is great to report on these activities in real-time as I did via Twitter (@InspiredHealth_) these last 2 weeks, these efforts still require a bit of reflection and deeper reporting. Hey, the movement on these issues deserves attention to be paid to keep the momentum going, to reinforce and recognize those who have mostly volunteered to take on these efforts. Now, as companies are finally investing money, the people who made these efforts continue to develop deserve recognition beyond a Tweet.   The first bit of recognition goes to the speakers and attendees of the Multicultural Health track at the DTC National meeting. As we moved through the day there were two themes – we all talked about the value of diversity in both the commercial and clinical trials spaces, and we all understood and utilized the value of community. The room was filled with all of us who “drink the Kool-Aid” on these issues. The challenge is to get out beyond those of us who already believe. Many of us are working together to build a coalition of organizations that represent diverse populations. We will help pharma get over the hurdle of accessing the very populations they need to reach to ensure clinical trials are diverse. Pharma knows it has to build sustained relationships to build trust and earn the right to ask people to participate in clinical trials – but how does this get done. We will help get that done. As this coalition is more formalized, in the next few weeks, watch this space for details. This theme continued at the Patients As Partners meeting in Philadelphia, April 28, 29, 2022. I am hopeful that industry is finally doing the work to be patient-centered – or as one speaker put it – patient inclusive.

By Sara Heath February 16, 2021 – When it comes to public health or medical research, there shouldn’t be any study about minority communities that doesn’t include minority communities. In failing to engage with stakeholders from racial, gender, or other underrepresented groups, researchers run the risk of perpetuating health equity barriers that result in health disparities. But in research, that overlooking of underrepresented groups is all too common. “Without research, we really are left with just a bunch of questions,” said Sheldon Fields, PhD, RN, CRNP, FNP-BC, AACRN, FAANP, FNAP, FAAN, 1st vice president at the National Black Nurses Association. “The problem becomes, research has not always historically included the most diverse populations,” Fields, who is also the associate dean for Equity and Inclusion at the Pennsylvania State University College of Nursing, told PatientEngagementHIT . “Or to state it another way, research has oftentimes left out a large number of people and focused a lot on the dominant White population living in the United States.” According to a 2019 study published in JAMA Oncology , the typical cancer clinical trial was about 76 percent White, while Asian patients usually represented about 18 percent of the trial population, Hispanic patients' 6 percent, and Black patients' 3 percent. READ MORE: Understanding Health Equity in Value-Based Patient Care This comes even as Black and Hispanic patients comprise 22 percent and 44 percent of the cancer incidence in the US, the study authors said. And it’s not just cancer clinical trials that are falling short. A perspective piece in the New England Journal of Medicine described racial disparities in COVID-19 research, and in 2019, Clinical Psychology Review published a study describing diversity issues in clinical trials for depression. These kinds of diversity issues can be really dangerous, considering the impact that clinical research can have on the medical field. According to Fields, not including certain populations in the clinical trial process can overlook an entire understanding of disease. For example, some of the oldest research about heart disease only looked at men, something that ultimately disadvantaged women experiencing heart disease because the illness manifested differently in them. Including women in the first studies about heart disease would have circumvented that issue. That perspective in NEJM , too, outlined a problem. Without enough information about how COVID-19 impacts communities of color, medical professionals cannot completely understand the disease that is so ravaging Black and Hispanic people. READ MORE: What Does Cultural Competence Mean for Healthcare Providers? But as they stand now, a history of distrust and poor community health engagement will hamper any efforts to diversify medical research. According to Fields, medical researchers cannot simply add more Black or Hispanic patients to their studies; they need to truly collaborate with these communities and include them in the study design in order to foster collaboration. Currently, that level of understanding and community engagement isn’t there, Fields stated. “There is a long-term dearth of cultural competence among the researchers who do not have the background or the appreciation of working with very diverse populations,” he said. “So, researchers have not really been exposed. They bring their own bias, whether conscious or unconscious, and they do not understand how they put people in boxes or all the way that they put up value to including the most diverse populations that they possibly can.” “Part of the other problem is the depth to which researchers understand the historical trauma that has been inflicted upon a lot of Black and Brown communities that really have been harmed by research done in the past,” he added. Take, for example, the Tuskegee syphilis experiment. That study, which conducted medical experimentation on Black bodies, resulted in disastrous public health effects and the death and illness of Black participants and their families. That is not easily forgotten, Fields said. READ MORE: Outreach, Cultural Competency Key to Clinical Trial Diversity “There have been undisputed historical atrocities,” he noted. “There is a level of mistrust that does exist.” Medical researchers without an understanding of that mistrust and the history behind it will likely not get very far in recruiting diverse patient populations for their studies, Fields said. “It is probably not going to be very well accepted, especially if you have not done your due diligence and did an honest partnership with a community that you are trying to include in your research,” he explained. “Basically, there should be no research done on us that does not include us,” Fields emphasized. “What that essentially means is if you are going to design any type of research study or clinical research outreach, clinical trial, whatever it is, it really should be planned in partnership with the community that you are trying to include.” This issue comes from the top, Fields suggested. In addition to a study participant diversity issue, the medical research industry faces a researcher diversity issue. Most of the medical researchers getting funding out of the NIH are White, Fields noted, which doesn’t help much to diversify the participant pool. “So NIH, even in its voter analysis, has admitted that there is a dearth of funding that has been done for principal investigators that are people of color,” Fields said. “The research that is still being funded is mainly White researchers. They are mostly the ones mainly being funded. Then, that sort of gets trickled down into the project—how what gets published and when it gets published, the dissemination of it, how it gets presented back.” In 2020, the NIH offered up some data a bout the race of researchers receiving certain types of grants in 2018. The data showed a 10 percent funding gap between Black and White researchers when controlling for factors like proportion of grant applications. When controlling for relevant factors, Black researchers received 2 percent of RO1 grants. As NIH continues its work to fund more Black researchers, Fields said it should also create requirements for more diversity within a trial participant pool. “If you really want to change it from the very top from the funding agencies, they need to start putting in the RFP requirements that your participants in your research must reflect the diversity of the population living in the United States,” he recommended. “You make it a criterion in order for you to get your funding. So, you say to those researchers, you must now include women, you must have diversity of races and ethnicities.” Fields said the NIH All of Us campaign has been a great proving ground for this, demonstrating the best way to create a field of diverse patient data used for medical research. “The participants are coming from all backgrounds, one million of them that will truly reflect the whole diversity of our country, and the research is going to use that database and really learn how biology, our lifestyle, the environment really affects our health,” he concluded. “It is going to provide a public resource because all types of researchers will have access to this database, particularly they are working within the requirements. The participants must reflect this type of diversity in a true partnership.”

Originally published in Clinical Leader From The Editor | January 19, 2021 Ed Miseta By Ed Miseta, Chief Editor, Clinical Leader Follow Me On Twitter @EdClinical In 2019 Amir Kalali celebrated the 10 th  anniversary of the CNS Summit. Kalali, biopharma executive, and the chairman and chief curator of the Summit, notes decentralized trials have been a hot session at the conference for the last few years. The individuals speaking on the topic have long felt the need for a space to gather the leaders in this area to work together. “We would get together once a year and discuss decentralized trials, but I always felt we could do better,” he says. “To really galvanize the community, I felt we needed a nonprofit group. I have founded nonprofits in the past, and felt it was the best way to bring everyone together, including industry, regulators, and patient groups. This was an idea we were discussing even prior to the pandemic.” The pandemic has certainly increased the urgency to create a group to promote decentralized trials. Amir Kalali and Craig Lipset, advisor and founder of Clinical Innovation Partners, spent a good portion of 2020 reaching out to pioneers in the clinical space who were working on decentralized trials. Conversations centered on the decentralized tools being used in trials and what more could be done to scale their use. They took what they learned and worked together to create the Decentralized Trials & Research Alliance (DTRA) to accelerate the adoption of decentralized methodologies in research. Lipset certainly understands the extent of the challenge. He has been involved with decentralized clinical trials for more than 10 years and has interacted with sponsors, sites, and tech companies. He notes this is one of the most active areas where he is seeing requests for help. “As the pandemic hit, those calls only escalated,” he states. “So many of the questions and needs that were raised were not unique to one individual company. I have had the pleasure of working with TransCelerate and CTTI, and I was able to see the power of multi-stakeholder initiatives and the potential for change they can bring. Unfortunately, there wasn’t any multi-stakeholder initiative exclusively focused on this challenge. That is the space we are going after with this initiative. "Now Is the Time Both Kalali and Lipset agree that when it comes to decentralized trials, now is the time for the entire industry to get behind the methodology. Initially the motivation behind decentralized trials revolved around improving patient access to trials, the patient experience, and diversity. Some companies may have been looking for cost savings which could result from better recruitment and retention. However, in 2020, the adoption of decentralized trials was driven by the pandemic and the desire to reduce risk and maintain continuity. Although risk mitigation drove the adoption, Lipset believes the desire to do right by patients is what will continue adoption in 2021 and beyond. “There is a long history of technology adoption happening slowly in the life sciences,” states Lipset. “We have quickly moved from testing the technology in pilots to rolling it out in active trials. The FDA did a great job of issuing specific guidance to industry around how to maintain trials during the pandemic. One of the things the pandemic did was cause companies to put aside the excuses they had for not implementing technologies within their portfolio. In 2020 companies no longer had a choice. New technologies had to be implemented to take care of trial participants.” DTRA is working with sponsors, patient groups, and sites, but it is also working with the service companies enabling decentralized trials. For Lipset, that was an important piece of the puzzle. Those companies have been attending conferences like the CNS Summit for years. The industry would gather at these events, everyone would share their stories and disperse. The goal with DTRA is to maintain that momentum with ongoing initiatives. “The membership of DTRA is diverse,” says Lipset. “That is what will make this group truly unique. We have top pharma companies, biotech firms, leading technology companies, and niche providers. We have CROs, patient advocacy groups, and the voice of the FDA. Every stakeholder involved in the conduct of clinical trials is represented in this group.” When it comes to decentralized methodologies as with any new approaches, not all companies are in the same place on that journey,” adds Kalali. “We hope one of the benefits of DTRA will be the ability of companies to learn from each other. The question is, how do we help them to do that? Sponsors can easily de-risk their own programs by finding someone else who is already doing it and learning from them. With DTRA, we hope they can meet, engage, and learn from each other.” Collaborate And Avoid Overlap Other groups, such as DiME, CTTI, and TransCelerate, to name a few, are also involved with promoting digital tools and decentralized trials. Lipset notes there is a complex web of organizations that have a hand in decentralized trial adoption. DTRA has been proactively reaching out to those organizations to ensure transparency around the scope of each organization. “We all benefit from some level of coordination between the groups and are actively launching collaborations,” says Lipset. “Some of the initiatives from different organizations may be solving a discreet challenge in the decentralized trial space. We have no interest in reinventing what has already been done. Still, we do hope to make connections that will help leaders simplify adoption. So far, there has been a lot of interest in partnering, and we hope to share more information on that in the coming weeks. ” Kalali adds that both he and Lipset have contacts within those groups, and one goal of DTRA is amplifying the good work those groups are doing and coordinate where possible. For those groups, decentralized trials are just part of what they do. DTRA hopes to be a clearing house and trusted voice in the industry for all things having to do with decentralized trials. Many of the same executives serve on many of these initiatives, which should foster greater collaboration. Give Patients Options Where does the effort go from here? Kalali notes DTRA had its first leadership council meeting in December 2020 and the future initiatives of the group will be based on the council’s vision. Some of the themes that were raised at that meeting include streamlined adoption of decentralized trial technologies and making the trials more mainstream. "Looking ahead we do not want to be discussing decentralized trials,” says Lipset. “We want to talk about clinical trials and know these technologies will be part of that. Decentralized technologies can no longer be an additional burden for overworked study teams. It needs to be the accepted way of conducting a trial in the future.” “The future is here,” adds Kalali. “Patients want options, and decentralized methodologies present them with those options. In the future, the average patient will be someone who grew up around technology and is familiar with using it. If pharma wants to have patients participate in trials, it needs to go where patients want them to be. The younger generation has gotten used to having these technologies in other sectors, and it is how patients will want to interact with trials. The risk for our studies going forward will no longer be whether we can introduce these technologies in our trials. The new risk will be not giving patients new opportunities to engage with trials. This is a real opportunity to create sustained momentum.” #NoGoingBack Supports Keeping Patients First

This is the first of a series of posts planned over the next few weeks. At the end of April, I finally attended my first in-person industry meeting in two years. I had the honor of presenting at the DTC National meeting during the Multicultural Health track, held in Boston. The next week I went to Philly to attend the Patients as Partners meeting. At each meeting almost every speaker, including me, opened with being grateful for being in person, seeing a live audience. The message thread through both meetings was the incredible evolution that is finally taking place in the life sciences industry. What I had been sensing in my gut was proven to be true – the life sciences industry – provoked by COVID and the death of George Floyd – is finally embracing: what it will take to improve how it engages with patients/people, that it is willing to do the work it takes to ensure that clinical trials are diverse, technology will help propel the industry on, at least, these fronts I am part of ongoing efforts to address these issues with the Digital Medicine Society (DiME), the Drug Information Association (DIA) and Patient Centered Outcomes Research Institute (PCORI). All of this activity is due to the momentum in the industry. All of these efforts are supported by people, like me, who have been pushing the industry for, at least, the last 15 years. While it is great to report on these activities in real-time as I did via Twitter (@InspiredHealth_) these last 2 weeks, these efforts still require a bit of reflection and deeper reporting. Hey, the movement on these issues deserves attention to be paid to keep the momentum going, to reinforce and recognize those who have mostly volunteered to take on these efforts. Now, as companies are finally investing money, the people who made these efforts continue to develop deserve recognition beyond a Tweet. The first bit of recognition goes to the speakers and attendees of the Multicultural Health track at the DTC National meeting. As we moved through the day there were two themes – we all talked about the value of diversity in both the commercial and clinical trials spaces, and we all understood and utilized the value of community. The room was filled with all of us who “drink the Kool-Aid” on these issues. The challenge is to get out beyond those of us who already believe. Many of us are working together to build a coalition of organizations that represent diverse populations. We will help pharma get over the hurdle of accessing the very populations they need to reach to ensure clinical trials are diverse. Pharma knows it has to build sustained relationships to build trust and earn the right to ask people to participate in clinical trials – but how does this get done. We will help get that done. As this coalition is more formalized, in the next few weeks, watch this space for details. This theme continued at the Patients as Partners meeting in Philadelphia, April 28-29, 2022. I am hopeful that industry is finally doing the work to be patient-centered – or as one speaker put it – patient inclusivity. Just my thoughts, Dyan Bryson

So, has the FDA finally decided to use its power to ensure diversity in clinical trials? I say a resounding “YES!!!!”. FINALLY. The guidance issued April 14, 2022, has the teeth needed to push the industry to finally DO something. This guidance draws heavily from the last guidance issued October 2016 . In that guidance the regulatory body suggested a the sponsor have a plan for diversity, if needed, by the end of the Phase II meeting. In this guidance there is a requirement for the plan before even filing for the IND. YEA!!! The document offers up the reasoning for this change: The purpose of this guidance is to provide recommendations to sponsors developing medical products2 on the approach for developing a Race and Ethnicity Diversity Plan (henceforth referred to as the “Plan”) to enroll representative numbers of participants from underrepresented racial and ethnic populations in the United States, such as Black or African American, Hispanic/Latino, Indigenous and Native American, Asian, Native Hawaiian and Other Pacific Islanders, and other persons of color, in clinical trials. Individuals from these populations are frequently underrepresented in biomedical research despite having a disproportionate disease burden for certain diseases relative to their proportional representation in the general population. Adequate representation of these populations in clinical trials and studies supporting regulatory submissions helps ensure that the data generated in the development program reflect the racial and ethnic diversity of the population expected to use the medical product if approved and may potentially identify effects on safety or efficacy outcomes that may be associated with or occur more frequently within these populations. Later in the relatively short, 12-page document, the FDA lays out a historical perspective on the need for this guidance: Some individuals from these groups have often been underrepresented in medical product development and FDA considers their representation in clinical trials and studies to be a priority. FDA has, for some of these populations, already published specific guidance (e.g., enrollment of women, including pregnant and lactating women, and older adults).14,15 However, FDA is focusing this guidance on diversity plans to improve enrollment of participants from underrepresented racial and ethnic populations because the lack of representation of these populations in clinical research reflects, in part, a broader issue regarding differential access to health care16, including access to centers that conduct clinical research programs for new therapies and awareness of clinical trials conducted there. In addition, mistrust of the clinical research system may stem from historical events that adversely impacted racial and ethnic minorities, such as the unethical Tuskegee experiments. Since the October 2016 guidance was issued the challenge to sponsors had been what to include in the plan, what was adequate. In this new document the FDA lays out what to include in the plan, how to assess the needs for the plan, how to identify the appropriate populations. As significant as all this is, I have to say, having been brought up in this industry on the commercial side of the business, this is not hard to do. On the commercial side this is simply an understanding of the epidemiology of the therapeutic area. As much as the FDA is leading industry by the hand on this plan, I would add that R&D should be meeting with their commercial colleagues to simply get an understanding of the potential market. This is NOT hard to do! Here are the FDA’s recommended Race and Ethnicity Diversity Plan elements: View a larger version of the Plan here   Here is a link to the April 14, 2022, guidance Life sciences industry – the FDA has been trying to encourage you to be more inclusive in clinical trials for decades. Finally, here is your roadmap to get it done. There are SO many of us who have been working in this space and can help you get this done. The elements of the plan are no strangers to us. The next posting will outline the resources that can help you get this done. No more excuses! Just my thoughts, Dyan Bryson

This is definitely a personal plug – a plug that can also help the pharma industry find a path to working in the diverse communities they are currently trying to sort through. I am excited to be a speaker at the upcoming DTC National Multicultural Health National meeting on April 20, 2022 . I will be talking about my concrete experience in helping pharma build sustained relationships in communities of color. Over the years I have built on the lessons from my first commercial initiative working with communities. This is the initiative I will present. Over time I have done this work pre-IND through commercialization. After all, it is only the situation that changes – R&D or commercial – not the people or their values and behaviors. This focus on the community will help improve diversity in clinical trials as well as have a positive impact on health equity. If you are truly interested in reaching diverse communities with your marketing efforts, you simply must engage the communities where your patients are. Where Pharma Needs to Put Their Money I have been at this patient-focused thing for more than 15 years. I was ready to give up on it, again, when the COVID pandemic hit. With COVID the industry started learning and actually addressing health equity issues. A few companies issued declarations and commitments to spend on diversity, equity, and inclusion (DEI) efforts. It has taken a while to really see these efforts come to fruition.  The $100MM and $300MM announcements are nice drops in a bucket of efforts that will really cost billions. Invest these dollars in community-based efforts and the companies will see a return – I have seen it; I have done it. Additional Perspectives of the Value of Community Engagement After presenting this community-based approach to one company, the team I presented to said to me that this is such a simple approach and asked me why aren’t other companies doing it? Great observation and question. I told them that this was a decision grounded in a company’s culture – simply a choice. This sentiment is echoed in the March 18, 2022, comments of Edward Mills PhD, FRCP, Professor, McMaster University during a webinar sponsored by the NIH Collaboratory at Duke University. Dr. Mills was part of a team presenting results of a clinical trial” Better Data on Ivermectin Is Finally Here: Results from the TOGETHER Trial “. Dr. Mills commented about how successful they were in recruiting for the trial at their site in Brazil, at the height of the pandemic. Dr. Mills attributed the success to the engagement the team had with the community. When asked to elaborate on this he was also asked why this engagement isn’t done more frequently he attributed this simply to the ego of the leadership. I concur. Working with the community seems like such an altruistic approach that there is little faith in the effort by the uninitiated. For more proof points please get to know C. Daniel Mullins PhD at the University of Maryland, Baltimore campus (UMBC), School of Pharmacy. For more than 20 years Dr. Mullins has been advocating for more community engagement and has established the PATIENTS Program at UMBC.  On the program’s website the PATIENTs Program is described as “The PATIENTS Program is an interdisciplinary research team of community partners and researchers housed at the University of Maryland School of Pharmacy that works to change the way we think about research by creating a path for health equity in West Baltimore.”. The principles may be taught to support West Baltimore – I am here to tell you the principles apply everywhere. People just need to put their scholarly egos on the back burner and go into the community to learn and apply. More Focused Than Ever So, as I was ready to quit, this community-based approach is continuing to be reinforced as the right approach. Being chosen to speak at DTC National will be great exposure for this thinking. Come support me, follow me, register for the event, keep your eye out for others as I pick myself up to continue the charge. Just my thoughts, Dyan Bryson

This is a commentary on “Why Poor Diversity in Medical Research Threatens Health Equity” first published on the Patient Engagement HIT website here . The article clearly recognizes the value of working with the community, however, there is more to say on this. Until I developed a project , sponsored by a biopharma company, I did not realize the impact of working with the community. What I see now, as the industry makes attempts at increasing diversity in clinical trials is that it, too, doubts the real value of working with the community. I want to be clear about what it means to work with the community. First of all, every community is different – there is no formula except figure what it is going to take to build long term sustainable relationships. This usually means identifying community leadership and community-based organizations with whom to work. These community-based organizations include non-profits, faith-based organizations, community health organizations, etc. This is an effort that requires you to talk to people, understand their perspective, understand their needs. You are right – this takes time. This is your investment to get the return you want – diverse participation in clinical trials. Through experience I can tell you that this investment of time is worth it. As the focus on clinical trials is to get them placed and recruited quickly – that balance of time and money – this time investment will take a bite out of your timeline at first. However, once your team has incorporated this effort into their schedules, this time expense will be a mere speed bump. Over time the relationships you build will enable quick placement and recruitment in the future. You will never get there if you never make this time commitment, period. So, read on, the article below provides additional links to some great resources. If you want to know more, my team and I can help you. We have been there, doing this work and getting results. Just my thoughts, Dyan Bryson