Protocol Support Committee Column: Addressing Diversity in Clinical Trials

02/12/2024

Written by Sharon Nicholson Harrell, DDS, MPH, FAGD, FICD, FADI, CDE®, the Chief Diversity Officer of FirstHealth of the Carolinas

I am intrigued by the world of clinical trials. Why, might you ask? As the inaugural Dental Director for FirstHealth of the Carolinas where we have been providing care to underserved children for the past 25 years and as the inaugural Chief Diversity Officer since 2021, clinical trials are not part of my everyday work. However, our integrated healthcare system located in the sandhills of North Carolina is fortunate to house an outstanding Clinical Trials Department in our brand-new Cancer Center who conduct robust, impactful clinical trials. In fact, my New Year’s Resolution is to learn more about the wonderful opportunities they provide to our community. Again, why am I so interested? There are two reasons that immediately come to mind. First of all, I’ve spent the last 25 years of my career providing care to underserved children, and my passion has always been to advocate and increase access in order to level the playing ground for kids who might not have had the same opportunities as others. In my inaugural role as Chief Diversity officer, my goal has been to ensure that all voices are heard; my intention is to bring other voices to the table, but never to push away the vital voices that are already there. In the clinical trials arena, there is much discussion about ways that more voices can be heard at the clinical trials leadership table (I had the opportunity to read the fascinating articleentitled “The room where it happens: addressing diversity, equity, and inclusion in National Clinical Trials Network clinical trial leadership” in the July 2023 newsletter), as well as many articles, posts, and blogs on increasing representation of people of color in clinical trials to ensure that the drugs work for everyone. So, my interest lies in bringing more voices to the table by increasing the participation of both underserved and minoritized populations in clinical trials.

The second reason for my interest is that my father participated in a clinical trial, over 22 years ago. While the drug did not prolong his life, our family would have made the decision all over again to participate. In many ways, it was the only hope we had. A supportive research team who explained everything thoroughly meant that we had absolutely no hesitancy in participating because they showed how much they cared for us months prior to the decision to undergo the clinical trial.

While completing our organization’s annual required training, I came across a five-step nursing process ¹ used to promote Patient Education and Health Literacy that might help to address some of the mistrust often given as a reason for the lack of participation in clinical trials by people of color. The five steps are Assessment, Diagnosis, Planning, Implementation, and Evaluation. While the information in each of the five steps are critical, for the purpose of this article, I will focus solely on the Assessment component, which if followed will lead to the ability to progress to the other four steps.

Assessment Components

1. Readiness to Learn – Is the patient receptive at all to hearing about the trial? Depending on the acuity of illness, the family may need to be involved particularly if follow-up visits or hospitalizations need to be arranged. So, the overall question is whether both the patient and the family are ready to learn? If not, the following four steps may assist them in their readiness to learn journey.

2. Past experiences – This is a huge one because it not only involves the past health care experiences of the individual patient, but the past health care experiences of the patient’s family, AND the past experiences of some races as a whole in prior clinical studies that we can all attest were egregious. Complicating the matter is the fact outlined by a colleague, that it takes 10 positive experiences to overcome one negative experience with an organization. Acknowledging the past and explaining how protocols are set up now is critical. Have there been any family members who have participated in clinical trials and what was the experience like? If there were negative outcomes, the “why” of the outcome that may never have been answered, can be articulated to assist with readiness to learn.

3. Health status – Is the patient physically strong enough to participate in the clinical trial?Do both the patient and the patient’s family agree that the clinical trial benefits outweigh the risks.

4. Anxiety level – Anxiety actually may need to be addressed first because readiness to learn can be adversely affected by the anxiety level of the patient and the family. That anxiety is already high due to the illness of the family member and uncertainty about the outcome; adding in the idea of yet another treatment or clinical trial to learn about and evaluate can increase the already high anxiety level. Once again, acknowledging the anxiety level and offering help in managing it by answering questions at a level that the patient can understand is very impactful. I learned early in my career that if I use one “clinical or technical” word that the patient doesn’t understand, I’ve lost them because they are still trying to figure out what that word meant, and I have already gone on to the next post-op instruction.

5. Environmental barriers – What is the environment from which the patient comes and in which the family still lives? Is there adequate money to make more trips to the healthcare facility? Are the family members at risk of losing their jobs with prolonged stays with the patient? Is there adequate water, heat, food to support the patient’s recovery and response to the drug once they return home? All of these factors feed into the whole person care concept practiced at FirstHealth which focuses on the social determinants of health—often defined as where patients are born, live, learn, work, and play.

In closing, there are no easy fixes to increasing diversity in clinical trials. However, addressing the first step of assessment in the nursing process started by Ida Jean Orlando in 1958 can still guide and impact care today.¹

¹Toney-Butler, TJ, Thayer JM. Nursing Process. NCBI Bookshelf.A service of the National Library of Medicine, National Institutes of Health. StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-.

https://www.ncbi.nlm.nih.gov/books/NBK499937/#:~:text=The%20nursing%20process%20functions%20as,planning%2C%20implementation%2C%20and%20evaluation.&text=Assessment%20is%20the%20first%20step,data%20collection%3B%20subjective%20and%20objective.