Discussions on Diversity
Section 1
About this report
Section 2
Building Relationships & Trust
Section 3
Research Awareness and Understanding
Section 4
Increasing Research Involvement
Section 5
Practical Barriers
Section 6
Decentralized Clinical Trials
Section 7
Institutional and Structural Racism
Section 8
Trial Feasibility
Black Participants
8%In Trials
VS
12.4%In General Population
White Participants
75%In Trials
VS
61.6%In General Population
Asian Participants
6%In Trials
VS
6%In General Population
Hispanic Participants
11%In Trials
VS
18.7%In General Population
There are also differences by indication, for example, in oncology clinical trials, where Black and Latinx trial participants have been consistently underrepresented based on cancer incidence and mortality in the United States.3
Science and society do recognize the importance of diverse representation in clinical trials, with inclusive health being a keystone to a just, equitable society. In addition, a study population lacking diversity weakens the ability of investigators to adequately understand the safety, efficacy, effectiveness and value of the potential new medication in the general population. The issues that persistently impact study populations are complex, involving a range of inequities in both opportunity and access.
Today, the pharmaceutical industry is gaining a much better grasp of the social determinants of health and health outcomes. Candid discussions between academia, industry, patients, advocacy organizations, physicians and communities provide insight into ways to effectively improve diversity in clinical research.
In order to make this a reality, we must truly commit to collaboratively engaging with patients from a diversity of races, ethnicities and cultures. Only then can we understand the barriers they experience and effectively mitigate them. Diversity and inclusion are possible for clinical trials—but our success depends on our continued, collective focus.
This Parexel report is a topline summary of an extensive, global, quantitative survey, focus group sessions, interviews and Patient Advisory Council meetings that called on patients, members of the public and physicians to provide their perspectives on clinical-trial diversity. Research was a collaborative effort produced with the aim of understanding the critical barriers to research access and obtaining guidance on how to successfully overcome them. To produce this report, the following methods were leveraged:
KEY TAKEAWAY
This report is the result of a series of studies conducted with patients, physicians, prospective clinical-trial participants, active and former clinical-trial participants. The findings of this research identify key barriers to clinical-trial inclusivity while also offering specific actions industry can take to address inequities in healthcare and clinical study access.
Acknowledgements
This report incorporates learnings and insights from data derived from a series of surveys and patient/physician focus groups, which gathered insights concerning various topics on clinical trial diversity. We thank all participants for their time, openness and expertise. While many were anonymous, we are pleased to acknowledge those who were not, namely:
Physicians and Site Staff Focus Group Participants
- Dr. Chika Anekwe
Obesity Medicine Physician, Massachusetts General Hospital; Instructor in Medicine, Harvard Medical School, Boston, MA, USA - Minnie Baylor-Henry
President, B-Henry & Associates, Boston, MA, USA - Dr. Sherri-Ann M. Burnett-Bowie
Assistant Professor of Medicine, Harvard Medical School and Director, Multicultural Affairs, Massachusetts General Hospital, Boston, MA, USA - Dr. Jacques Carter
Assistant Professor of Medicine, Harvard Medical School, Cambridge, MA, USA - Wanda McClain
Former Vice-President, Community Health and Health Equity, Brigham Health, Boston, MA, USA - Dr. Shelly McDonald-Pinkett
Chief Medical Officer, Howard University Hospital, Washington, DC, USA - Dr. Oludamilola Olajide
Hematologist/Oncologist, University of North Carolina REX Healthcare, Chapel Hill, NC, USA - Dr. John Otasowie
Consultant Child and Adolescent Psychiatrist at the Fraser Health Authority Surrey Memorial Hospital, BC, Canada - Dr. Kaya Oyejide
Family Medicine Physician, University of Pennsylvania, Philadelphia, PA, USA - Dr. Fabian Sandoval
CEO, Emerson Clinical Research Institute, Falls Church, VA, USA - Dr. Valerie Stone
Professor of Medicine, Harvard Medical School; Vice-Chair for Diversity, Equity, and Inclusion at Brigham and Women’s Hospital, Boston, MA, USA - Dr. Winfred Williams
Associate Chief, Division of Nephrology & Transplant; Founding Director for Center for Diversity and Inclusion, Massachusetts General Hospital, Boston, MA, USA - Dr. Kathleen Young
Psychiatrist, New York, NY, USA
Patient Advisory Council Members
- Trishna Bharadia
Health Advocate and Patient Engagement Champion, UK - Ivis Febus-Sampayo
Patient Advocate, Chief Officer of Diversity and Inclusion and Senior Director of Public Outreach at SHARE Cancer Support, USA - Sheila Khawaja
Rare Disease Patient Advocate and World Alliance of Pituitary Organizations Board Member, Italy - Malini Raj
Patient Advocate, Non-Executive Director of the Australian Pituitary Foundation and Board Advisor for the World Alliance of Pituitary Organizations, Australia - Alfred Samuels
Keynote and Public Speaker, Patient Advocate and Author, UK - Grace Samuels
Retired NHS Nurse, Care Quality Commission Specialist Advisor, Patient Caregiver and Advocate, UK - Yasmeem Watson
Research, Patient and Consumer Advocate, USA
PAREXEL TEAM MEMBERS
- Elisa Galvez
Feasibility Leader - Kushal Gohil
Vice-President, Corporate Strategy and Innovation - Nichola Gokool
Senior Director, Medical Communications - Mwango Kashoki
Vice-President, Regulatory Affairs - Andreza Martins
Project Specialist, Patient Innovation Center - Sarah Pilkington
Associate Director, Patient Innovation Center - Baljit Samra
Corporate Vice-President, Clinical Operations - Altair Silva
Director, Patient Recruitment Strategy Group
The contents of this report are the opinions of third parties derived from surveys, focus group sessions, interviews and patient advisory group meetings and do not reflect the opinions or positions of Parexel or its affiliates.
Woodcock J, Anagnostiadis E, Lolic M. Center for Drug Evaluation and Research, U.S. Food & Drug Administration. (2020). 2019 Drug Trials Snapshots Summary Report.
Population Distribution by Race/Ethnicity (2019). https://www.kff.org/other/state-indicator/distribution-by-raceethnicity/. Accessed January 8, 2021.
Loree JM, Anand S, Dasari A, et al. Disparity of race reporting and representation in clinical trials leading to cancer drug approvals from 2008 to 2018. JAMA Oncol. 2019;5(10):e191870.
Building relationships and trust
Research results highlight a significant lack of trust in medicine in many communities, particularly related to the pharmaceutical industry. Patient concerns about receiving a placebo, negative medical events in history and a perceived lack of the physician’s understanding of some racial and ethnic groups have all been attributed to these feelings of mistrust and skepticism by participants.
I would want to do a lot of research before doing a clinical trial. I think people of color have to be very careful. I know how Black women were treated and studied without previous consent in the past. I would personally be hesitant in joining a clinical trial.
Interviewee
Member of the Public
Such a view was also reflected in a physician's experiences:
Building trust is therefore critical to engagement in clinical research and will require enhanced patient engagement activities by site personnel:
And, though outreach via advertising was not rated highly by any survey respondents, when it is utilized, preferences are as follows:
Trusted Information Source (Media)
Supplementary to this, participant interviewees and Patient Advisory Council members alike expressed that engagement with trusted community advocates to share research information and education is critical to success:
We have to meet patients where they actually are; they may not be in a medical center. You may have to go to a community center, a religious organization or local barbershops. If we train some community advocates, people who are in the community every day and who are trusted, you would be surprised at the level of complexity of conversations that happen.
Yasmeem Watson
Patient Advisory Council Member
Family opinion was also viewed as important, with one phyisican explaining:
And, though outreach via advertising was not rated highly by any survey respondents, when it is utilized, preferences are as follows:
In the global survey, doctors were regarded as the most trusted source of clinical-trial information
58% of Black, Latinx, Asian, and Indigenous respondents [N = 237] compared to 69% of white respondents [N = 1,945]
KEY TAKEAWAY
Results show a multipronged approach to promoting clinical research education through trusted site staff, advertising channels and advocates will benefit broader awareness, understanding and, in turn, improve research access.
Building Relationships Between Patients and Site Staff
During both physician focus groups and Patient Advisory Council discussions, patients being treated by site staff of the same race, ethnicity or cultural background was viewed as being a very important aspect of increasing diversity in clinical research and one that can prove difficult to achieve.
Interestingly, interviews with members of the public and quantitative research results indicated that this was a far less significant consideration, with a combined 20% of Black, Latinx, Asian and Indigenous participants globally compared to 11% of white participants citing it as important.
I don’t believe ethnic background has any influence in qualifications or anything to do with my confidence in the safety of the study.
Interviewee
Member of the Public
The reason for such differences in opinion was not explored in the research. However, it could perhaps be a result of those with greater experience with medical interactions citing this as a key consideration. Partnering with sites with greater staff diversity could therefore help address the current gap in research participation among some racial and ethnic groups, and the issue certainly warrants further exploration.
When it is not possible for patients to be treated by site staff from a similar racial, ethnic and/or cultural background, it is critical for staff to understand and accommodate differences in cultural norms. This helps patients, caregivers and families feel comfortable, build trust and ensure that they are making treatment decisions that are right for them.
There are cultural differences that are not accepted or even considered within the medical community. Sometimes, entire families come to an appointment because everyone wants to be involved in medical decisions. It’s just different things that you have to pay attention to.
Yasmeem Watson
Patient Advisory Council Member
KEY TAKEAWAY
Respondents to this research highlighted a preference by many patients for being treated by someone who looks like them. Where this is not possible, some site staff may benefit from cultural competency training to optimize the patient experience.
Research Awareness and Understanding
Generally, clinical research awareness, understanding and trust are all low among research participants, something common across the world. During the COVID-19 pandemic, clinical research was under a microscope, especially in places like the United States, where mixed messages related to the virus, the vaccine and protective measures.
An increased focus on clinical trials and research presents an opportunity to educate people about participating in clinical trials and the potential benefit these trials have in finding new medications and treatments for a range of diseases with unmet medical needs.
This awareness and understanding also affects different communities’ perceptions of physicians going into research:
KEY TAKEAWAY
An increased focus on clinical trials and research presents an opportunity to educate people about participating in clinical trials and the potential benefit these trials have in finding new medications and treatments for COVID-19 and other diseases.
Increasing Research Involvement
For those physicians not working in hospitals where clinical research is the norm, knowing how to get involved was also cited as a key challenge. To overcome this, long-term mentorship, adequate financial compensation, and guidance and training provided early in a career path by those with experience was cited as an important way to address this barrier. In turn, this could successfully increase the rates of clinical research involvement for physicians from all backgrounds:
It’s much more than training and education. There must be an offer of employment and sponsorship...
Dr. Shelly McDonald Pinkett
Physician Focus Group Participant
Also important is hospital infrastructure, as support and funding that includes assistance from the pharmaceutical industry could greatly help with the undertaking of clinical research on an ongoing basis and lead to success:
It is well known that involvement in clinical research is low across the entire healthcare profession. A lack of training on the topic during medical school and lack of exposure within hospitals are likely the primary reasons for this. Physician participants agreed that these barriers exist but that being paid less to lead research than to see patients was also a deterrent. This underscores the need to educate about the importance of clinical trials and medical research while removing barriers related to earnings, such as accessible grants.
Training existing sites on new approaches for accessing a diversity of communities as well as enhancing the diversity of sites by selecting and partnering with new sites and physicians from different racial and ethnic backgrounds would be worthwhile. Approaching new sites outside of the large inner-city teaching hospitals will also be important in order to reach physicians who are working in community hospitals. In particular, sites that have already built trust with communities by working with them and getting to know them better would greatly improve diversity in clinical research.
I love the idea of healthcare workers being involved in the community, who are able to speak to specific trials and explain to patients in their own language what it really means to participate and the potential benefit it offers to the community.
Dr. Shelly McDonald-Pinkett
Physician Focus Group Participant
Practical Barriers
Qualitative results from Patient Advisory Council and physician focus groups highlighted that clinical trial participants often need to receive information in their primary language and, as with all patients, simple, nontechnical terms. The use of videos and infographics will also aid in building trust and understanding.
As one patient told us:
In Queens, New York City, we have 250 languages. We do not expect every hospital to have all those translations, but we can at least pick 5 or 10 major languages within the areas where you want to reach out and bring diversity into trials. Yes, it’s going to be more expensive, but the value that is going to bring and the respect that it is showing to this community means that it’s explained in a way that someone can understand.
Ivis Febus-Sampayo
Patient Advisory Council Member
KEY TAKEAWAY
Offering clinical trial information in plain, easy to understand and appropriate languages is something industry can do swiftly to promote better research access.
Financial and other practical barriers, such as provision for childcare during visits, also pose significant challenges to trial participation for many patients, regardless of race or ethnicity. That said, such barriers were highlighted in the quantitative research by a greater proportion of Black, Latinx, Asian and Indigenous participants than white participants. For example, the number of required study visits was cited as the greatest barrier, followed by visit duration and payment for travel and for participation:
As one patient told us:
Clinical trials, especially those within minorities and in certain areas, need to be accessible for those with limitations, both physically and financially. Many forget that even in this day and age not everyone has access to the internet or public forms of transportation.
Interviewee
Member of the Public
These barriers do not only affect the patient but also the caregiver. Caregivers are an often under-considered yet vitally important element to the success of any clinical trial and act as trusted advocates in the clinical trial process.
KEY TAKEAWAY
Reducing or eliminating practical and logistical challenges could have a significant impact on improving research across patient groups.
Reimbursement for time and travel is widely accepted by ethics committees/institutional review boards but is not always included as part of trial strategies. Similarly, decentralized clinical trials (DCTs) that center research around patient convenience and delivery in their home or community are increasing in popularity but are not yet the norm.
To successfully improve research and address the lack of adequate diverse representation in clinical research for many of those who are most affected by the illnesses being studied, both of the strategies mentioned above are recommended.
Some women, some African American women, don’t have time to come to chemo because they have children at home that have to be cared for. They don’t have time to come to medical appointments. They would love to be cured and love to be healed, but sometimes it is beyond their control. If you’re just saying, ‘Okay, they can’t come to the appointment, moving on to the next patient, that’s not going to help anyone. We’ve got to get behind the problem, to understand and solve the problem.
Yasmeem Watson
Patient Advisory Council Member
Decentralized Clinical Trials (DCTs)
As previously mentioned, DCTs can help overcome many barriers to research involvement. However, our experience shows that the needs and preferences of patients and caregivers must be carefully considered on a study-by-study basis. The disease in question and the daily challenges it brings have a huge impact on the individual home-based strategy that is to be deployed. That said, quantitative research results showed little difference between respondent groups in terms of preferences of DCT options, with home medication deliveries (42%), phone apps (40%) and wearables (40%) being the most interesting options, though a similar proportion also preferred in-hospital involvement (40%):
Clinical Trial Consideration Factors
During the qualitative research, the aforementioned secrecy surrounding illnesses for many communities was cited as a potential barrier to home-based participation:
Many haven’t told their extended family; they haven’t told the wider community. So if they were taking part in a decentralized clinical trial, that could expose them. Many don’t want healthcare professionals coming to their houses because then neighbors will know something is wrong.
Trishna Bharadia
Patient Advisory Council Member
KEY TAKEAWAY
DCTs should be approached with flexibility and an understanding of the needs of different communities.
This will ensure that the benefit of reduced patient and caregiver burden is not in conflict with their needs. An adaptive, flexible approach can facilitate patients being seen in locations nearby, such as hotels, rather than in the home, in order to maintain privacy and still make research more accessible.
Also discussed was the lack of access to WiFi or a good data plan for some participants, which could create a challenge for study-based patient apps and telehealth visits. This can be overcome by the sponsor provisioning devices and data plans, which should be incorporated into the planning stage of a study, based on upfront conversations with patients and site staff. The pandemic has shown that such an approach can be highly beneficial to patient oversight and engagement, with one physician stating:
Institutional and Structural Racism
During physician focus groups, several practical considerations were raised that were not highlighted when learning from patients. There was a general sense that neither minority patients nor minority physicians receive the same opportunities for research involvement as their white counterparts. Both societal and institutional changes will be required to level the playing field in this regard:
This was also highlighted during the Patient Advisory Council as another element that can lead to mistrust:
Physicians also highlighted a perceived lack of representation within the pharmaceutical industry as being a barrier to achieving equity in clinical research access. With the industry focused on diversity, the situation continues to evolve with the extension of inclusive practices to ensure greater representation:
KEY TAKEAWAY
Proactively engaging with existing sites to support them in accessing a diversity of communities and selecting and partnering with new sites that work with patients from underrepresented backgrounds is an important step to more inclusive clinical research.
Trial Feasibility
During discussions, it was noted that the pharmaceutical industry tends to work with a similar pool of sites with a proven track record. With an ongoing lack of patient representation, particularly from the Black community, the industry must be more deliberate with their site-selection process to enhance trial diversity:
Pharma companies need to make sure they update their feasibility questionnaires so that sites can be proud of the fact that they have a diverse community culture to bring these types of patients into the studies.
Dr. Fabian Sandoval
Physician Focus Group Participant
Physicians also provided feedback that the pharmaceutical industry has historically been perceived as reluctant to ask questions outright about diversity in patient populations or staff for fear of causing offense. Without resolution, this could limit progress toward proactively inclusive practices that improve representation within clinical research.
Secrecy about illness was reported by participants from both Black and South Asian backgrounds, which they explained can impact how patients and their families seek medical treatment and the willingness to take part in clinical research.
Diversity Research Participants Voices
Yasmeem Watson
Research, Patient and Consumer Advocate, USA
Malini Raj
Patient Advocate, Non-Executive Director of the Australian Pituitary Foundation and Board Advisor for the World Alliance of Pituitary Organizations, Australia
Minnie Baylor-Henry
President, B-Henry & Associates, Boston, MA, USA
Dr. Valerie Stone
Professor of Medicine, Harvard Medical School; Vice-Chair for Diversity, Equity, and Inclusion at Brigham and Women’s Hospital, Boston, MA, USA
Yasmeem Watson
Yasmeem Watson is a research, patient and consumer advocate, as well as a Stage III colon cancer survivor. She is a member of Fight Colorectal Cancer’s (FCRC) Research Advocacy Training and Support (RATS) Program and has dedicated herself to impactful research advocacy initiatives, including but not limited to serving as a consumer advocate on the Department of Defense’s Peer Review Cancer Research Program, the Alliance for Clinical Trials in Oncology, the Patient-Centered Outcomes Research Initiative (PCORI) and the American Association for Cancer Research Scientist↔Survivor Program.
There is mistrust among diverse, underserved communities pertaining to the medical sector. This report identifies some of the obstacles and factors in needed solutions. The patient’s voice is of most importance if the goal is to diversify clinical trials. There are many components of a patient’s journey, yet not feeling acknowledged may be the most heartbreaking. The feeling that your skin color or language is not a barrier to receiving adequate care is priceless.
Malini Raj
Malini Raj is a patient advocate, Non-Executive Director of the Australian Pituitary Foundation and member of the World Alliance of Pituitary Organizations. Malini is a strong patient advocate for Cushing’s disease, since she is a patient herself, diagnosed in 2013 after a 20-year journey to diagnosis.
Our society is not homogenous, hence a one size fits all approach is not appropriate. This is particularly true when it comes to such important and sensitive issues as health and the design of clinical trials and research approaches in order to optimize outcomes for all stakeholders.
Society as we know it is extremely ethnically diverse and multicultural. Each of these minority groups have specific needs, views, opinions and cultural nuances which shape the way they interact, react or engage in society and how they are impacted. These unique characteristics need to be considered, acknowledged and incorporated to ensure these groups are adequately represented in clinical research. As a patient from an ethnic minority group, I commend Parexel for their efforts in acknowledging the need for more diversity in clinical trials and research, and for using a multipronged approach to thoroughly understand the critical barriers that seem to be precluding adequate diversity in trials that is reflective of society.
It is refreshing to see this report has successfully drawn out some very key issues that may be contributing to the lack of diversity in clinical trials, such as awareness. Identification of the issues is the first step to making change.
From my perspective, some highlights that resonate include:
- The need for open communication and dialogue with ethnic minorities to address the lack of trust and improve understanding of the purpose and process of the trial
- The recognition of the need for strong collaboration, using trusted sources in the community to act as a bridge and leveraging relevant communication channels and formats
- The imperative to take the time to recognize and respect cultural nuances and cultural stigmas and stereotypes centered around health, the importance of family and community, and who needs to be involved in the decision-making process
- Acknowledgement of financial and physical limitations that may not be present in the mainstream population and being open to considering other locations or centers that may allow a greater diversity of participants
- Recognition that support, education and awareness need to be focused not only on potential patients / participants but also the physicians/clinicians, and an understanding by each party as to the important role they can potentially play in positive clinical trial representation and outcomes
As a patient, I would appreciate it if any or all of the above, is always kept front of mind, as it will allow greater empathy, cultural competency and understanding among those who are designing approaches or engagement strategies for clinical trials, and a greater likelihood for patients like me to be included, to contribute and to have a voice.
This diversity in clinical trials research is a needed and important first step to shine a light on the structural issues and ensure that there is greater awareness of the need for increased ethnic diversity in clinical trial participation. However, it also goes one step further in that it provides consistent insights that highlight some of the key barriers precluding clinical trial participation that can be addressed or further explored to allow participation to be truly reflective of the community in which we live.
Minnie Baylor-Henry
Minnie Baylor-Henry, JD, is currently President of B-Henry & Associates, LLC, and executive partner of YourEncore, a leading provider of proven expertise to the life sciences and consumer goods industries. Previously, she was the worldwide Vice-President of regulatory affairs-medical devices for Johnson & Johnson. She also serves on Howard University’s Board of Trustees.
As we face the many complexities of a public health crisis brought about by a global pandemic, Black and Brown people, along with other disaffected people globally, are watching as society confronts the reality of many years of healthcare inequalities. Society is now forced to grapple with the intersection of culture, race and class and the impact this has had on our fragile healthcare infrastructure. The pandemic, layered on top of the countless incidents of social unrest, has brought to the forefront, the reality of the many inequities in our healthcare systems.
When questions arise regarding the reluctance of Black and Brown people, for example, to trust the healthcare systems and allow a vaccine to be administered, historic mistreatment is uppermost in their mind. Have Black and Brown people been denied opportunities to participate in clinical research regarding treatments for diseases that primarily impact their communities? Why are Black and Brown people being asked to put aside their mistrust and believe that this year, at this time, everyone will receive equitable treatment and consideration? Why have there been minimal efforts to understand how to reach diverse communities in order to assure a better understanding of health concerns? How does the healthcare system restore trust in these disenfranchised communities after they’ve endured years of being damaged physically and emotionally?
This report provides some global insights into the issues facing Black and Brown communities that are now at a crossroads regarding how to respond to an unprecedented public health crisis. The report touches on the impact of structural, cultural and institutional biases and the resulting challenges for healthcare providers going forward. However, more research is needed if we are going to tackle the many injustices affecting all disadvantaged people globally.
Dr. Valerie Stone
Valerie Stone, MD, MPH, is Vice-Chair for diversity, equity, and inclusion of the Department of Medicine at Brigham and Women’s Hospital. Dr. Stone is an academic general internist as well as an infectious disease specialist and is a Professor of Medicine at Harvard Medical School.
Black, Indigenous and People of Color (BIPOC) are disproportionately affected by every major disease. This is true of diabetes mellitus, hypertension, cardiac disease, and cancer—the major chronic illnesses of our time. It is equally true of the life-threatening infectious diseases—tuberculosis and HIV, and now COVID-19. In contrast, however, BIPOC are underrepresented in clinical trials for the study of new treatments and preventive interventions for all these diseases. While this has been a concern for decades, the confluence of the COVID-19 pandemic’s inequitable impact on communities of color and our collective enhanced commitment to racial justice has made this a more urgent concern.
We know that the underrepresentation of BIPOC in clinical trials is at least in part a result of mistrust due to historical abuses of Black and Brown people in research and in clinical care. We also know that some of the underrepresentation is due to continued inequities and racial injustices in healthcare and beyond. Given this, if we hope to improve the representation of BIPOC in clinical trials, we must make active efforts to “move the needle.” Herein, we share important new findings from quantitative and qualitative research among diverse community members and diverse physicians about what it will take to enhance clinical trial heterogeneity. This report provides concrete ways that researchers and industry can become more trustworthy—by partnering with diverse communities in new and authentic ways and investing in building research capacity in diverse communities. We hope that you find this information of value to you in your work.