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Blog: Health Forward Blog
Posted: 03 May 2022 8 min. read


ACHIEVING CLINICAL-TRIAL DIVERSITY REQUIRES TRUST, AWARENESS, ACCESS


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By Neil Lesser, principal, Deloitte Consulting, LLP

Not everyone responds the same way to medicines and vaccines. A patient’s race,
ethnicity, age, and gender could all influence how well a drug performs. While
clinical trials are essential in the development of safe and effective medicines
and vaccines, trial participants often don’t reflect the patient population that
is likely to use a newly approved drug. As we noted in our November 2021 report,
data generated by clinical trials can increase the understanding of certain
diseases, which can improve prevention and treatment for all populations,
including racially and ethnically diverse communities.


Nearly 80% of patients who participate in clinical trials are white, according
to a multi-year study conducted by the US Food & Drug Administration (FDA).1
Moreover, less than 20% of approved drugs have data that evaluated the treatment
benefits or side-effects on Black patients, according to a recent report from
Health Affairs.2


Regulators, pharmaceutical companies, patient-advocacy groups, and industry
trade organizations have long recognized the importance of diversity in clinical
trials. On April 13, the FDA issued new draft guidance for enrolling more
participants from underrepresented racial and ethnic populations in clinical
trials. This expands on the FDA’s previous guidance for improving diversity. In
late 2020, the Pharmaceutical Research and Manufacturers of America (PhRMA)
published industry-wide principles on clinical-trial diversity.3  


Pharma companies target trust, awareness, and access 


Last month, I led a panel discussion on enhancing clinical-trial diversity. My
panelists, who represented three large pharmaceutical companies, agreed that
three barriers—trust, awareness, and access—limit the level of diversity in
clinical trials. Here’s how they are working to remove those barriers.  

 * Trust: Experiences with structural racism—including the Tuskegee Syphilis
   Study, which ended in 1972—continue to drive significant distrust of the
   government, pharmaceutical companies, and the health care sector in general.
   This distrust is sometimes further magnified by personal experiences, rumors,
   or traditions. Jorge Hechavarria, Ph.D., senior director of diversity, equity
   & inclusion in clinical trials at Janssen (the pharmaceutical companies of
   Johnson & Johnson), said pharmaceutical companies can build trust by
   continuing to engage with patients even after the trial concludes. He
   suggested that pharmaceutical companies could tap former clinical-trial
   participants to serve as ambassadors by describing their experiences with the
   trial. In 1996, a good prognosis for a myeloma patient was five to six years,
   he explained. Today, some patient ambassadors are cancer-free 20 or 25 years
   later. “This progress is largely because some patients took a chance and
   trusted the clinical trial.” 
 * Awareness: Some people might not understand the benefits of clinical trials.
   They might not know how trials work, or even that they exist. More than 80%
   of PhRMA member companies said lack of awareness was a major barrier to
   recruiting underrepresented populations in clinical trials, according to our
   report, Enhancing clinical trial diversity. Some patients might be willing to
   participate in a clinical trial if they are aware of it. A lack of awareness
   among patients might reflect a lack of awareness amongst physicians, or
   biases that investigators have when seeking patients who may be eligible to
   participate in clinical trials, explained Judy Sewards, vice president and
   head of clinical-trial experience at Pfizer. “In our landmark COVID-19
   vaccine trial, we took care to ensure that we selected clinical-trial sites
   in communities where we saw high rates of COVID-19 infections,” she
   explained. The company wanted to help reduce or eliminate any transportation
   issues that might keep people from participating. She added that that Pfizer
   also partnered with “trusted voices” (e.g., community, medical, and
   grassroots organizations) to help improve awareness. Information and
   listening sessions were held to answer questions about the clinical trials
   and to collect feedback from community partners. The feedback was then used
   to create educational materials that were tailored to the community, Judy
   explained.
 * Access: All patients, regardless of background or social status, should have
   the opportunity to participate in clinical trials that are developing the
   latest breakthrough medicines, Judy said. However, a wide range of factors
   can make it difficult for some people to participate in clinical research.
   Some people might not be able to take time away from work. The cost of
   childcare and travel might also hinder access. Although virtual clinical
   trials have helped to expand access to some participants, people who lack
   reliable internet connectivity might be unable to participate virtually. A
   data-driven approach to identifying clinical trial sites might help improve
   access, suggested LaShell Robinson, director of diversity and inclusion in
   clinical trials at Takeda. She suggested that feasibility questionnaires
   (used to evaluate potential sites) could ask about staff diversity, languages
   spoken by staff, or demographics of the patient population. “We are embedding
   and factoring for diversity as a component in site selection,” she said.

Pharma companies might need to be myth busters


The COVID-19 pandemic shined a light on health disparities. In the US, the virus
had a disproportionate impact in Black and Latino communities. LaShell said the
pandemic created an opportunity to dispel some of the myths about clinical
trials and explain how research and development affects medications. Takeda has
begun asking its investigative sites to collect information about the race and
ethnicity of participating patients and is urging them to make sure that the
trials are accessible. “Unconscious biases can seep into that process and really
impact awareness, access, and participation in communities of color,” she
explained.

Jorge agreed that many pharmaceutical companies are battling conflicting
messages and misinformation, particularly in communities of color. He also
suggested that using investigators who look like members of a community could
help put patients more at ease. 


Pharmaceutical companies are using a wide range of tactics to attract a more
diverse patient population. Some are forging partnerships with community
organizations to build trust, spread awareness, and improve access. Others are
providing participants with financial support, and a few are looking to move
some trials to convenient locations, such as retail clinics, as my colleague
Dawn Anderson described in a recent blog. 


Even the best intentions won’t move the needle on clinical-trial diversity
unless the strategies are implemented, Jorge said. Commitment from the top is
critically important. Most large biopharma companies have identified equitable
access and equity in research as a material issue in their environmental,
social, and corporate governance disclosures, and many have assigned improvement
as a priority for senior management.  


 

This publication contains general information only and Deloitte is not, by means
of this publication, rendering accounting, business, financial, investment,
legal, tax, or other professional advice or services. This publication is not a
substitute for such professional advice or services, nor should it be used as a
basis for any decision or action that may affect your business. Before making
any decision or taking any action that may affect your business, you should
consult a qualified professional advisor.


Deloitte shall not be responsible for any loss sustained by any person who
relies on this publication.

 

About Deloitte


Deloitte refers to one or more of Deloitte Touche Tohmatsu Limited, a UK private
company limited by guarantee (“DTTL”), its network of member firms, and their
related entities. DTTL and each of its member firms are legally separate and
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Certain services may not be available to attest clients under the rules and
regulations of public accounting. Please see www.deloitte.com/about to learn
more about our global network of member firms.

Copyright © 2022 Deloitte Development LLC. All rights reserved.

 

1 2015-2019: Drug Trials Snapshots, US FDA, November 2020


2 Despite the FDA’s five-year plan, Black patients remain inadequately
represented in clinical trials for drugs, Health Affairs, March 2022

3 PhRMA announces first-ever, industry-wide principles on clinical-trial
diversity, PhRMA press release, November 17, 2020

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NEIL LESSER

Principal | Life Sciences | Monitor Deloitte
nlesser@deloitte.com
+1 215 446 4364

Neil is a principal with Deloitte Consulting LLP in the Life Sciences strategy
practice and a leader in the Research & Development strategy practice. He joined
Deloitte in 1998 and works with life sciences executives creating and
implementing strategies that drive productivity,... efficiency, and value. He
leads strategy, operating model design, productivity improvement, and large
transformation initiatives within R&D and Regulatory Affairs. Neil is a frequent
writer and speaker on R&D productivity.

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