Beyond The Standard Patient: Increasing Diversity By Prioritizing Inclusion
By Kathryn Ticknor, Senior Research Manager, Inspire
The lack of diversity of age, race, and gender in clinical trials significantly impacts healthcare in several ways. Most acknowledge the importance of a diversified patient pool in accelerating medical discovery and pre-empting safety issues that may surface post-approval. A lack of diversity can foster ongoing distrust of medical institutions. And trials designed for a homogeneous group often result in avoidable hurdles to recruitment and retention.
While the challenge is well-defined, some still find themselves questioning to what extent diversity initiatives are necessary in the rapidly growing field of precision and genomic medicine.
At the Clinical Leader Forum in Philadelphia last month, I moderated a panel of experts working to tackle the lack of diversity in most clinical trials. Our panel included John Whyte (director of professional affairs and stakeholder engagement, FDA), Fabian Sandoval (CEO and research director, Emerson Clinical Research Institute), Karen Brooks (senior director of clinical operations, Adare Pharmaceuticals), and Theresa Devins (senior director of site operations and strategic alliance development, Boehringer Ingelheim).
The statistics are familiar: Clinical trial pools are rarely representative of the wider population. African-Americans represent about 13 percent of the total U.S. population but comprise about 7 percent of clinical trial participants, according to the FDA’s Drug Trials Snapshots Summary Report. Similarly, those of Hispanic or Latino descent account for 17 percent1 of the total population but an estimated 1 percent of clinical trial participants.2
With this knowledge, we asked our audience members three questions. 1. How many attendees come from organizations that value diversity? 2. How many come from organizations that prioritize diversity? 3. How many attendees acknowledge their own personal biases that may impact their ability to effectively address the “problem” of diversification?
Many attendees said they valued diversity, but fewer said their organizations prioritized a solution. And fewer still considered how their own personal biases might influence the success of diversity initiatives. Before organizations can move from simply acknowledging the importance of diversity to actively prioritizing it, we must step back and put participants in the driver’s seat. It is a focus on inclusion through patient engagement that ultimately drives both successful diversification as well as meaningful medical discovery.
To increase diversity, communicate inclusion.
During our panel, Karen Brooks pointed out the importance of changing corporate culture. Outside of the pharmaceutical industry, programs aimed at increasing organizational representation across age, gender, ethnicity, and other social affiliations are often referred to as "diversity and inclusion" initiatives, or "D&I" for short. The word “inclusion” in partnership with diversity is crucial to the success of this framework. It recognizes the need to actively engage those outside one’s own worldview and experience.
Throughout the healthcare industry, use of the terms “patient centricity” and “patient engagement” are increasing, but techniques aimed at putting patients at the center of the process are often employed well after the point at which patients could make a meaningful impact on the products and services that make up their healthcare. When patients do provide feedback on aspects of a trial’s design they find problematic, sponsors often feel it is too late or too costly to implement their recommendations. Yet many trials fail to enroll a single patient, often due to protocol requirements that don’t reflect real world expectations.3
Likewise, while many have recognized the importance of diversification in clinical research, the discussion tends to be focused around about increasing the percentages of women or ethnic minorities participating in trials. Yet much less time has been spent focused on understanding the priorities, beliefs, motivations, and challenges of those seeking to enroll in trials.
In the context of organizational communication, the very definition of diversity is “the ideology of including people with different backgrounds and beliefs.” Again, we see that within the definition of diversity is a commitment to prioritizing inclusion and understanding beliefs that may be different than our own.
Why do these definitions matter? Will changing how we communicate about diversity, to emphasize inclusion, really solve the problem? As Brooks reminded us, changing how we think of these concepts includes changing how we talk about them. And when our words change, ultimately so does our ability to take action. It’s time to take the important next step from simply recognizing this lack of diversity and its impact on healthcare to actively prioritizing methods that put the participant at the center in the R&D process. Actively communicating to participants that they are to be included not just in the trial, but in its design, sends that important message.
I am not a proxy for my participants.
One of the toughest barriers to engaging patients starts with acknowledging the need to listen directly to the patient voice — rather than our own intuitions. In many ways our own experiences, biases, and professional vision prevent us from seeing clinical research design through the eyes of our participants — least of all those from different backgrounds than our own.
Researchers partnering with clinicians found they were frustrated by patients who were called and informed of abnormal lab results but who later seemed to have no memory of being given the news. When a linguist observed a few interactions, a closer look at the communication dynamic revealed a simple explanation — patients were told their lab results had come back elevated. For medical professionals, “elevated” was clearly abnormal — negative. But their patients had dismissed the news, considering their results to have been “above average.” Similar studies have described patient “non-compliance” after receiving news of “positive” biopsies. Where but in a clinical context does that word imply a negative? Once patient-focused research began, both barriers were quickly identified.
These are just two examples of how thinking differently about the words and phrases we take for granted is so important. Clinical language used frequently by professionals often translates differently into everyday talk, and can have major consequences for those seeking to enroll — and successfully stay enrolled — in clinical studies.
It’s crucial to take the time to answer the question, “What is most important to patients in this study?” It is too easy to say, “What would be most important to me?” Through inclusion and patient engagement, we are exposed to, and able to practice, the art of admitting, “I would have never thought of that.”
Engagement starts outside the exam room and before the trial.
When we suggest patient engagement initiatives during the trial design or early trial phase process, we often hear concerns around expense and timeline. Clinical teams are concerned that engaging patients will be costly, will require extensive IRB approval, and may slow down their ability to move forward with recruitment under already tight timelines.
However, embracing patient centricity at the very start of the process, by reaching out to the patients, loved ones, and their communities, improves outcomes in the long term. Several of our CLF experts stressed the importance of partnering with advocacy organizations to engage with trusted communities where an authentic dialogue can be established. These are most often with patients’ primary care physicians, or outside the exam room all together: with community churches, advocacy organizations, and even support groups and social networks.
When working with these groups, the use of established, qualitative methods informed by the social sciences lends scientific rigor while putting the patient voice front and center. Qualitative interviewing, for example, is an established methodology used throughout the consumer health space to inform product and messaging pre-launch and throughout the lifecycle of the molecule. Such methods allow for smaller — yet representative — sample sizes and abbreviated timelines, and engage patients early in the design process.
Community-based, qualitative research techniques are often a rapid, cost-effective way to engage patients and foster inclusion and diversity. Qualitative methods such as these can be paired with more traditional quantitative techniques to produce what we call a thick description or thick data, which benefits not just from the scale of data points but from the richness of the insights, emotional depth, and first-person perspective.4
Aligning with patients on their terms — in their words — is needed to move from a “guinea pig” discourse to a “hero” discourse by understanding patient fears.
The Bennett scale, or the Developmental Model of Intercultural Sensitivity (DMIS), is a framework that describes the different ways in which people react to cultural differences.5 Initially, we may accept the existence of differences but minimize their importance as superficial. As we strive to become more informed of how culture affects a wide range of human experiences — such as healthcare — we can work toward a true integration and inclusion of different cultural worldviews into the design of clinical trials.
References:
- U.S. Census QuickFacts: https://www.census.gov/quickfacts/table/PST045216/00
- FDA Drug Trials Snapshots and Diversity When Testing New Drugs: https://blogs.fda.gov/fdavoice/index.php/2017/02/fda-drug-trials-snapshots-and-diversity-when-testing-new-drugs/
- Tufts CSDD Impact Report: http://csdd.tufts.edu/files/uploads/jan-feb_2013_ir_summary.pdf
- “Big Data Needs Thick Data”: http://ethnographymatters.net/blog/2013/05/13/big-data-needs-thick-data/
- The Developmental Model of Intercultural Sensitivity: http://www.idrinstitute.org/page.asp?menu1=15
About The Author:
Kathryn Ticknor is senior research manager at Inspire. As a health communications and medical marketing researcher, she draws on expertise in linguistic insights, ethnography, and human-centered design. Motivated by her own family's experience with chronic illness, she has focused her work on in-depth, disease-state specific research supporting partners across the healthcare space.