Bridging the Gap: Strategies for Addressing Racial, Ethnic and Cultural Disparities in Clinical Research

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Discussions on Diversity Report

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Executive Summary

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Discussions on Diversity

Black Participants

8%In Trials


12.4%In General Population

White Participants

75%In Trials


61.6%In General Population

Asian Participants

6%In Trials


6%In General Population

Hispanic Participants

11%In Trials


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:


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.


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


  • 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). 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. 


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]


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.


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


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:


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


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.


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.


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


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:


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.