CMPH Journal

Knowledge about Clinical Trials

Participants were asked to describe their level of knowledge about clinical trials. At least half admitted that they knew very little about clinical trials. One participant stated, “My knowledge about clinical trials is just simple …the basic knowledge I see online or in books.” Others told what they perceived to be the purpose of clinical trials. Nine participants stated that clinical trials were research studies to test a new medical device, treatment, or drug. As explained by these participants:

Clinical trials are research studies performed on people that are aimed at evaluating a medical, surgical, or behavioral intervention.

You could say it’s like some kind of research study to tell how people respond to treatment, like try new methods of disease prevention.

I think clinical trials is subjecting people to test a new drug. I mean to know the responses and the adverse effects of the drug on each person.

A few of the participants or someone in their family had participated in a clinical trial. The trials mentioned were ADHD and multiple myeloma. As these participants stated:

I actually participated in a clinical trial for multiple myeloma. It lasted, I believe, about 18 months.

I have been invited to get involved in several others since the completion of the one that I did before. But they were not things that necessarily interested me, so I passed on those.

Information regarding Clinical Trials

When participants were asked how often they receive information about clinical trials, five spoke up to say, “rarely” or “not often.” One stated, “I have never received clinical trial invitations for accessible studies.” Two had received information 1-2 times per year. If participants wanted information regarding clinical trials, they looked in numerous places. Health care providers, social media, and the internet were the most mentioned (Table 3).

Table 3: Places Where Participants Sought Information Regarding Clinical Trials.

Trusted Sources of Information for Clinical Trials

Participants were asked “Who would you most trust as a source of information about clinical trials?” Twenty-five concurred that they trusted information from their health care providers. At least 13 trusted social media or the internet for clinical trial information. As one stated, “I would actually go to the website, use keywords and be specific if I wanted to find something out…clinical trials on African Americans with high blood pressure, heart disease, or obesity.” Other trusted sources included:

• Webinars
• Clinical trial website
• Friends, family members
• Community members
• Community schools
• Informed colleagues or doctoral researchers
• Government agencies
• Relatives in the medical field
• Mail correspondence
• Celebrities

My personal feeling is, if you utilize a celebrity, who, in fact, is either familiar with or has whatever the issue, I think that would carry a lot of credibility.

• Pastors
• Community leaders

It boils down to the infrastructure more than anything. Having the infrastructure in our communities and the leaders who look like use in those positions and carrying out these trials.”

• HBCUs
• Health Department
• Health journal
• Insurance website

Helpful Information regarding Clinical Trials

Seven of the participants preferred receiving clear “facts and figures” over information they felt was unrelated to the benefits of participating. Remarks included:

It’s helpful if I’m being educated on the outcome…People need to know what they are about to participate in and it’s not going to harm them. I don’t want to hear about having side effects.

It should also be encouraging that people know by participating in a clinical trial they are going to be indirectly solving problems of others.

I would want full disclosure of everything if I’m going to be involved in the good, bad, and the dirty as well. We need proper education on the risks and benefits of the clinical trial.

I am skeptical about some stuff, you know, these different medicines. I think the doctors are really just making us guinea pigs. But when it came down to COVID, I was like I got to get this shot.

Motivation to Participate in Clinical Trials

The participants revealed many pros and cons of participation in clinical trials. The top pro of participating was to impact the community’s health or to help their personal health. Many mentioned the fear of side effects and time needed to participate as a con of participating in clinical trials. More pros and cons are listed in Table 4.

Table 4: Motivation to Participate in Clinical Trials.

Description of their Community

The focus group participants were asked to describe their community. Most said their community was predominately Black or African American residents. There were three that said their community consisted of Black Muslims. Others were mixed or diverse communities. As stated by these participants:

We have a mixture, but mostly we have white people in my community.

I would say that my community is both urban and suburban as well as city. I think there’s a pretty good blend…depending on what area you live in.

It’s mainly pretty diverse. There’s a combination of Whites and

Blacks and Hispanics, and they’re not all in the same exact section. But at the same time, if I look at my block, I could say that I’m the only person of color that lives on my block.

Information and Messaging Needs of the Community about Clinical Trials

Questions were asked about possible information needed by the community about clinical trials and what type of messaging would be best to communicate this information. Knowing about the health benefit, possible risks and side effects was top of their list. Knowing all the facts and what types of clinical trials are available was also valuable information for the community and what compensation will be provided. Other suggestions include:

My community needs to understand that it is important for our population to participate in clinical trials. Most of us take high blood pressure pills. Well, the study that was done at the Framingham study, was just done on people that don’t look like us. If we are not part of these studies, they will never know how we be affected.

I think it should focus more about the type of clinical trial it is, maybe for what type of disease. Also, the information should assure them of safe health.

We should prepare the community for understanding what clinical research is and why we do it. You want to dispel of the

myths and urban messages about research and replace that with more positive messages.

I think an explanation of how the information in the clinical trial is going to be used and how your information is going to be secured and kept confidential would probably be something to include in a message about trials.

The participants felt the best messaging was through social media, flyers, newsletters, and radio stations. “The radio is key. Everyone listens to some African American dominated radio station, whether it’s gospel or hip hop.” Another recommended that the flyers should be a true representation of people of color. Other suggestions for messaging include:

When it comes to trying to reach other people, you know most times you tend to find yourself in a rural community and not everyone has access to the Internet. So, reaching out to

businesses like the barber shop, house salon, the movie theatres, restaurants, you know. I think it helps, spread the information faster than social media.

The communities that I am involved with are predominantly African American communities and mostly impoverished.

Information that’s needed sometimes come to them in more scientific terms that many of the community don’t understand. Word of mouth may be the best ways, because our communities tend to rely a great deal on social media that [don’t] touch the lives of many people outside of the black churches.

The content of the message has to be such that I can explain it to you once I hear it, and then it can be disseminated very easily. If it’s too technical it’s not going to go very far.

Discussion

Our lay community focus group study provides insight into racial and ethnic community participation in clinical trial studies. Our study identified that lack of knowledge and access to information, and trust are some of the barriers to clinical trial study participation.

Most focus group participants viewed clinical trials as research designed to test treatments or medications, with only a few reporting prior participation in such studies. Most focus group participants viewed clinical trials as research designed to test treatments or medications, with only a few reporting prior participation in such studies. While mistrust of research was noted, the primary concern preventing most participants from joining a clinical trial was the fear of potential side effects. Participants emphasized the importance of providing accurate and realistic information about clinical trials to their community, including details on procedures like blood draws, potential side effects, trial duration, and the use of collected data. The most trusted resource for information about clinical trials was physicians or their health care providers. However, most participants had never received information from their health care providers about clinical trials.

In summary, our study highlights barriers to clinical trial participation within racial and ethnic communities, including fear of side effects, mistrust, and limited access to information. Addressing these challenges requires culturally tailored outreach, transparent communication about trial processes, and leveraging trusted sources like healthcare providers. These efforts are crucial for fostering trust, enhancing participation, and ensuring equitable representation in clinical research.

Ethical Considerations

The study is approved by Florida A&M University Institutional Review Board.

Conflict of Interest: The authors disclose no conflict of interest.

Funding

This project is supported by the Food and Drug Administration (FDA) Office of Minority Health and Health Equity of the U.S Department of Health and Human Services (HHS) as part of a financial assistance award [FAIN] totalling $707280.00 with 100 percent funded by FDA OMHHE/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.

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