Health is much more than numbers, medications, or a clinical diagnosis. A person’s health is affected by their environment and their lived experiences.
People with access to healthy food, shelter, education, and quality health care are less likely to experience negative health outcomes than people who live in communities facing structural racism, pollution, and violence.
Clinical trials are the main scientific method of determining whether treatments and interventions are effective.
Clinical trials are critically important for advancing science and medicine. Yet there are a number of historical and cultural reasons why they have typically not represented the diversity of lived experiences. In recent years, the National Institutes of Health (NIH) and health policy agencies have been striving to increase diversity, equity, and inclusion (DEI) in clinical trials. The goal is to improve clinical research by making it more inclusive of populations experiencing health disparities, including communities of color, people in the LGBTQ+ community, and socioeconomically disadvantaged populations.
Medical writers are well-positioned to help ensure that clinical trials are designed, implemented, and reported with DEI principles in mind.
Medical communicators also hold significant power and influence when it comes to using inclusive language in health communication materials. It is our responsibility to learn and share these principles, as they evolve to reflect changing demographics and identities.
The Importance of Clinical Trials
Clinical trials are foundational in the development of treatments, medications, and devices. This type of research helps us learn strategies for disease detection, understand whether interventions are safe and effective, learn about side effects, and improve the lives of people facing illness or chronic medical issues.
Participation in clinical trials is voluntary. People volunteer to participate for a variety of reasons: many want to contribute to scientific knowledge and help others, some are seeking an intervention for a disease or condition without FDA-approved treatments, and still others are trying out new interventions in different doses, contexts, or situations.
However, the fact remains that health and disease do not appear equally across populations, and a person’s life context has a significant impact on their health. Therefore, successful clinical trials need to take into account differences in lived experiences and characteristics such as race, poverty, sex, and sexual orientation. The principles of DEI can help inform the design and implementation of clinical trials to make them more representative and useful in creating a healthier, more equal society.
Risk Factors
The NIH has documented a number of factors that affect health outcomes. Those factors include:
- Age
- Biological sex
- Pregnancy status
- Life experiences such as stress, trauma, lack of resources or opportunities
- Unhealthy behaviors such as substance use, lack of exercise, overeating, or risky sexual activity
- Health-promoting behaviors like seeing a doctor regularly, getting adequate sleep and exercise, and eating nutritious foods
- Environmental factors such as pollution, access to health care and healthy food, and neighborhood segregation
- Genetics and ancestry
- Underlying medical problems or comorbidities
A Troubled History
In the past, clinical trial participants were predominantly white males, leading to gaps in knowledge about how to address health challenges in other populations. This flaw in the system is one of the many factors that contribute to unequal health outcomes.
Individuals involved in clinical trials at any level should be familiar with the history of malfeasance that has led to distrust in the medical and research establishment, particularly among communities of color in the US. One of the most poignant examples was the U.S. Public Health Service Syphilis Study at Tuskegee, 1932-72, where researchers withheld critical health information from 399 participants, all Black men, who were infected with syphilis – including their diagnosis. Even after penicillin treatment became available, researchers did not inform or offer treatment to the study participants.
Tragedies like this necessitated a response by the scientific community and eventually led to the Belmont Report, written by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and published in 1976. The Belmont Report names ethical principles and spells out guidelines for informed consent.
However, the report did not end the problems related to informed consent in clinical research. As an example, in 2003 members of the Havasupai Tribe in Northern Arizona discovered that their DNA samples, which had been given for a diabetes study, were being used in other research.
Today’s clinical studies are reviewed by Institutional Review Boards, which monitor study protocols for compliance with ethical principles. Interestingly, a 2005 paper found that Black and Latino individuals were as likely to participate in health research as white individuals.
This is encouraging, because it means researchers and medical communicators can understand the past while focusing on the present and future of clinical research. However, it also means that the medical and scientific community bears the responsibility of identifying and alleviating barriers to clinical trial enrollment for a diverse population of patients.
Inclusion in Clinical Trials
To truly understand whether a treatment or device will benefit all potential patients, clinical trials need to reflect the population in general and address the unequal health outcomes of various populations. For example, during the early phase of the COVID-19 pandemic, people of color experienced disproportionate levels of cases, hospitalizations, and deaths. However, clinical trials for Coronavirus vaccines used inclusive recruitment practices to test the safety and efficacy of vaccines in diverse populations.
Similarly, asthma has a disproportionate effect on individuals living in urban communities because of the elevated risk of exposure to tobacco smoke, chronic social stress, and inadequate nutrition. Good clinical research on asthma and other conditions needs to take these factors into account.
Additional research has revealed health disparities in LGBTQ+ populations. Information regarding sexual orientation and gender identity (SOGI) is not required to be collected in clinical settings, which may contribute to a lack of data on key indicators.
Socioeconomic status (SES) is another predictor of health outcomes that is often overlooked in clinical trial design. Even though SES affects many health indicators, the NIH is promoting practices that make it easier for low-income people to participate in trials by adapting locations and hours, offering child care or transportation, and paying attention to social determinants of health—the context where people are born, live, work, and age.
A number of resources exist to help researchers and medical communicators learn to create inclusive, equitable practices.
Relevant Guidelines and Resources
The NIH published the NIH Revitalization Act of 1993, which includes guidelines for the Inclusion of Women and Minorities as Participants Involving Human Subjects. The goal of this policy is to ensure that research findings are generalizable to the entire population and that clinical trials are designed to determine whether outcomes are different for women and other historically marginalized communities.
Importantly, applicants for NIH-funded studies need to address these inclusion concerns in their grant proposals. Applications and proposals need to specify the sex or gender, race, and ethnic composition of the proposed study population.
The PhenX Toolkit is a valuable resource for understanding how to design and conduct research that takes into account people’s lived experiences.
The Food and Drug Administration’s online Clinical Trial Diversity resources also offer tools for creating more inclusive and equitable clinical trials.
The NIH has demonstrated its commitment to reducing health disparities by creating a strategic plan that focuses on DEI in clinical trials it funds. The National Institutes of Health Minority Health and Health Disparities Strategic Plan 2021-2025 provides a blueprint for applying DEI principles in scientific research.
Inclusive Research for More Equitable Outcomes
Many scientists are striving to make clinical research more inclusive and attentive to the realities of living in this unequal society, but there is always room for improvement.
Medical communicators can start by understanding the history and shortcomings of past research, learning from the many resources available, and championing inclusive practices.
Because communicators work with words, another critical opportunity for medical writers and editors is mastering and championing inclusive language, which avoids stigmatizing terms and attempts to center the voices and identities of historically marginalized groups: communities of color, LGBTQIA individuals, and people with disabilities.
Inclusive Language
Inclusive language is a concept that is rapidly developing, and medical communicators can often become leaders in organizations by incorporating inclusive language practices into their daily work and sharing best practices with colleagues and clients.
A session on inclusive language at the 2022 Medical Writing & Communication Conference and later published in the AMWA Journal spells out key terms and describes inclusive language practices for describing race, ethnicity, gender identity, and sexual orientation.
Inclusive language practices avoid generalizations, stigmatizing terms, and terms that make people feel othered. Inclusive language invites people in and respects people’s identities.
The speakers at the conference suggested that medical communicators ask themselves the following questions when approaching documents: “Is the terminology or language used relevant, accurate, inclusive, respectful and thoughtful?” If it doesn’t meet all those criteria, perhaps it is something that can—or should—be changed.
Resources on Inclusive Language
When seeking answers to questions on inclusive language, consult an appropriate style guide. The American Medical Association’s Advancing Health Equity: A Guide to Language, Narrative, and Concepts is an important resource.
Medical communicators should be aware that the AMA Manual of Style committee continuously posts updates to address evolving guidelines on correct and preferred language.
The Health Resources & Services Administration has a guide based on the Health Equity Guiding Principles for Inclusive Communications from the Centers for Disease Control (CDC).
Some medical communicators create inclusive language style guides for their company or clients to offer alternatives to terms such as “minorities,” “mixed race,” or “at-risk.”
The Medical Writing & Communication Conference presenters also offer constructive approaches to discussing inclusive language with clients and colleagues, including linking them to resources, keeping a log of feedback, and customizing software to address inclusive language principles.
Language matters, and when medical communicators strive to center principles of equity and inclusion, more equitable outcomes are possible.
Toward a Healthy, More Equitable System
The goal of research and medical communication should be to improve the lives and health of as many people as possible. However, significant health disparities show that the goal is not being met.
As the authors of Advancing Health Equity: A Guide to Language, Narrative and Concepts write, “The evidence—the science—shows that even despite great intentions, some decisions made at the practice and institution level, and by individuals themselves, are not meeting our intended desired impact to ensure the full potential for optimal health for our patients. Most alarmingly, there are signs some of our systems continue to exert harm, creating and perpetuating inequities.”
Medicine, science, and language are continually evolving, and medical communicators will spend a lifetime learning and working toward making a healthier society. Acknowledging disparities, striving for inclusion in clinical trials, and harnessing the power of inclusive language in medical communication are steps in the right direction.
AMWA acknowledges the contributions of Jodie Rothschild for peer review in the development of this AMWA resource.
