Addressing Underrepresentation

Underrepresentation in clinical trials and research leads to inequities in healthcare.

Samantha Zylberman, RN, BSN, MS, and Crystal Loucel, MPH, MS, RN, CDES, share tips for getting started in clinical research. You'll also learn about the role of nurses in clinical research and the impact of nurses in clinical trials and research recruitment and retention.

Supported by Cytokinetics, Incorporated, and Novartis Pharmaceuticals Corporation.

Video Transcript

Samantha (00:13):

Hi, Crystal. I'm so excited to be here with you. It's so nice to meet another clinical research nurse. I feel like the clinical research nurse role is so important and yet not many people know about it. So I'm happy to talk to you today and I want to hear a little bit about what you do. So can you tell me what you're working on now?

Crystal (00:34):

Yes, and I agree. It is so exciting and it's been great to connect with another research nurse because there aren't too many of us. I entered research nursing through two parallel paths. First was as a nursing member of the National Association of Hispanic Nurses, where I've been a member for 14 years now since nursing school. And my chapter received a grant for obesity prevention in San Francisco's Latinx community exposing me to research funding, data collection, and implementation. This showed me that research could be community based and not just in a lab. The second way was during Covid at the county hospital where I was working as a diabetes nurse educator. I saw how diabetes really worsened outcomes and with many family members affected by diabetes. I wanted to make an impact more on the prevention and treatment side on a larger scale, and this led me to a per diem research job at UCSF. Right now, I'm working on a first in human trial, transplanting eyelid cells and parathyroid clans from deceased donors into patients with type one diabetes into their forearm muscle. And we hope that multiple transplants will reduce insulin dependence and long-term complications like heart disease. How about yourself?

Samantha (01:56):

That's fascinating work that you do. I have always been fascinated by research. I love the idea of exploring what else is out there and constantly learning about our world around us. And I completed a graduate program in nursing health policy, which was a wonderful program that delved really deep into the research process and focused on using evidence-based findings to influence health policy, so to benefit the health of people on a macro scale. And so through that program, I gained a deep understanding of the research process and that really solidified my interest in being involved in research. So tell me more about your day to day. What are you actually doing as a clinical research nurse?

Crystal (02:43):

As a research nurse, I do very similar things to what I would do as a clinic nurse, except with maybe more of a lens, looking at a specific protocol every time I interact with a patient. And I do everything the same way for every patient, every time. And there's a very detailed recorded process on everything that I do with the patient and everything that the patient reports we're looking for any side effects, we're looking for any complications, any worsening of their condition, and any signs that the treatment that we've provided is harming them. I still triage. I provide nursing advice, provide diabetes education to my patients. I review the CGMs and pumps, I pen orders and medications to our providers. I review lab results with the patients. I schedule appointments and I coordinate care with the members of the team, including lab, pharmacy, the surgeons, our inpatient staff for hospitalizations, our clinic staff or research follow-up visits. And I get to see patients and just chat with them about how their health is doing. How about you?

Samantha (03:55):

Yeah, my role is very similar. I spend a lot of time reviewing the protocol and making sure that everything gets executed and documented and recorded in a very specific way according to that protocol. One thing I love about the job is that it involves a lot of education, both educating myself on the new treatment and how it works, and then educating the patients on what they can expect and what symptoms they should be reporting, when to report to the hospital, et cetera. And then there's a lot of education involving the staff as well. The staff needs to know how to take care of patients on these novel treatments that they may have never seen before. Depending on the protocol, I may do direct patient care and administer the treatment myself and do the bedside monitoring. In other times, I'm sort of training the bedside nurse to perform the administration themselves through a thorough handoff process. And kind of like you said, my responsibilities include a lot of coordinating of care. There's always talking to the investigator and the study team to our physicians to pharmacy coordinating inpatient admissions or outpatient treatments. So that takes up a lot of my time as well.

Crystal (05:15):

I am sure you've worked in nursing for a long time and realized how important it is to be part of a healthcare team. And myself, I realized that clinical trials are like healthcare teams as well. They are a healthcare team, but in addition to that, we rely on diverse participants to find effective treatments. And just as we need different specialists on the healthcare team, from nurses to pharmacists to therapists to provide that comprehensive care for the patients, research needs diverse populations to uncover those meaningful insights. Humans share 99.9% of their DNA and that 0.1% difference that we have is key to discovering new treatments. If one person lacks a protein while another one produces it, research can use that knowledge to develop solutions. But we need both people to participate so we can find the issues, but we can also find treatments. How about for yourself? What do you see in working with diverse populations for your work?

Samantha (06:21):

Yeah, I feel very fortunate to be working at UCSF because we do have a very diverse population of patients. And I think that just lends itself to research in, I just think first and foremost, when you're a part of a research, when you're part of a study or a clinical trial, I think back to the foundation of what makes good quality research. And for me, that's generalizability, which that's the degree to which the findings of a research trial can be applied to everybody. So how can we determine if a new medication is safe and effective for everybody? If we're not testing it in everybody, we need a diverse population to confirm that this intervention is going to work for all people. Not only do we all have different genetic makeups, but we all eat different foods, and we live in different environments, and we have varying degrees of exposure to sunlight or exercise or pesticides or what have you, or different genders or different ages. So all of these factors are going to have an effect on a drug's metabolism or efficacy. The more people we test on, the more we can be sure it will or will not help everybody. So I think that's just sort of the core of quality research is getting a diverse population involved in the trial. And then I also think back to my core nursing principles, right?

Crystal (07:47):

And what I'm seeing these days is a lot of research organizations and nonprofit organizations are funding trials to help bring about more diversity in their study population and in their staff. For example, the NIH National Institute for Health has a program called the All of Us program, and the Alzheimer's Association is also actively recruiting underrepresented communities. These efforts help address disparities in conditions like Alzheimer's disease because it disproportionately affects blacks at twice the rate as white people and the Latinx population at one and a half times the rate of white people. But participation isn't always accessible to everyone. Some people like my father who's retired, has his own home, has transportation, and has really easy access to participate in research trial. He lives in the Los Angeles metropolitan area. There are other people who, because of where they live in a rural area, lack of transportation, the distance language barriers, full-time jobs or caregiving responsibilities have a more difficult time accessing these trials. And I'm seeing more and more resource organizations putting more resources into trying to make studies accessible for everyone so that everyone can really benefit, not just those who have access.

Samantha (09:17):

You mentioned professional nursing organizations, and many people don't know this, but clinical research nurses do have a professional organization. It's the International Association of Clinical Research Nurses, or I-A-C-R-N. I'm a member, and I can say that it is a wonderful platform for research nurses across the globe coming together as a community seeking to define clinical research nursing and recognize it as an esteemed specialty of nursing. And so I always recommend that if anybody has an interest in becoming more involved, they're a great resource.

Crystal (09:52):

Yeah, I think we as nurses, one of the wonderful things about our profession is the variety of roles that we can do and the variety of the work within our roles that we're able to do. You don't have to be a research nurse to be involved in research. For example, when I have a patient in the hospital, there are nurses who are providing care inpatient, and they're always curious to ask about what our study does, how it's going, and they're learning about these new procedures and are able to share it with their other patients or with their family members. And I think one of the best ways to increase awareness of clinical trials and enrolling participants in diverse backgrounds is being a research participant yourself. So as a nurse, one of the ways is the nurse's health study, and about 35% of nurses are involved in research of some kind as a participant.

(10:52):

And there's an opportunity for a hundred percent of nurses to be involved in a study like the Nurses health study, which has come up with some really great information that then has informed research for non nurses. And I've really had a great experience being involved in research. I've gotten some benefit from it. I've learned a lot from it as well. And I feel really good about contributing to the health of the future because as a Hispanic person, I know that it's difficult to reach the Hispanic population because there's been a lot of mistrust in the community from previous studies that were not considerate of people's bodies or their rights. And so I'm happy to be able to contribute in that sort of way. What are some other tips that you might give to help increase research awareness and diversity in trials?

Samantha (11:52):

Yeah, thanks for asking. I think supporting a diverse nursing population is a great place to begin so your patients can feel connected and feel more trusting of you and of the healthcare team. I think research has shown in the past that that's definitely helpful and helping people feel comfortable just accessing the healthcare system and being more likely to seek out clinical trials and more likely to enroll in clinical trials. What are some of the other methods that you've implemented or think would help to increase diversity in clinical trial enrollment?

Crystal (12:29):

Knowing that myself as a Hispanic nurse, one of the things I do is I just involve my family. I have a large extended family from both sides of my parents and I get them involved. So my father, my sister, we've all participated in the NIH All of US program and the Alzheimer's studies. My dad has been involved in research and he is really into it. He's really passionate about helping find treatments and prevention. So he's done things from MRI scans, blood tests, genetic testing, and even some fun cognitive computer gain where he's very competitive and he does it from a passion of trying to help other family members prevent Alzheimer's or slow down the process of it. And one thing I think a lot of people don't know about participating in research is there are different levels of participation, but one thing that people should know is if at any point in a study you don't feel like you can participate anymore, you have the right to stop, no questions asked, you just let your coordinator know, you know what?

(13:38):

I don't want to go further with this at this time. I'm going to opt out, and that's totally okay. And in the past, maybe people didn't feel like they had that option, weren't aware, or they were coerced into doing and staying in a research study. So I think that's something that's changed over time that I think is really important. As a nurse working in a clinic, there are always research studies going on. And so I would go find some of these studies or our hospital would partner with organizations to find studies for our patients. And just sometimes simply asking a patient if they wanted to participate was just the connection that they needed to get involved. Even if they didn't speak English as their main language, there's often interpreters or the documentation is available in their language. So that made it easier for the participants to want to get involved.

(14:33):

And I find that in my experience working with patients living with diabetes, most of them want to help other people who are also experiencing the same chronic disease, not have to go through their same experience and live a better, longer, healthier life. And there's always opportunities to get involved on research studies through what's called the cab, the community advisory Board. You help the researchers recruit, you help give them advice on how to best present the information, how to connect to the community and really reach the people where they are in a language that they understand. And so I've had experience doing that and I've really enjoyed it and being able to contribute in that way. I've also been a board member of the Hispanic Nurses Association, and there's always opportunities to connect with organizations who are looking to diversify their studies by looking for Hispanic population. So is there anything else that you think you would add?

Samantha (15:35):

No, I think you've done a great job in touching on all of the important points, and I think you bring up really important information about the different ways to get involved in the different stages at which to get involved. And one thing I just want to highlight that you said, which I really appreciate and I agree with you, I think that most patients do want to be involved in research. I think most patients really do have an altruistic outlook that they'd want to help not only themselves or their family members, but just anybody else but the disease. That's what I found in my studies as well, and I like to hear you say that. And I think it's our job as nurses to make it as easy for them as possible to be able to participate. You had mentioned language and documents in the primary language, and that's something that I encounter in my job regularly.

(16:22):

We have informed consent forms that go over the clinical trial. That's part of the research process. Prior to enrolling a patient, you need to review the informed consent form and make sure that the patient knows exactly what the trial is asking of them, making sure they can fully understand and making sure they have any questions and that all of their questions are answered before they enroll. How would they understand information about the trial if they're not reading about it in their own language? So doing our due diligence as nurses, making sure we get them the informed consent forms in their languages, making sure we have our interpreters present, making sure that we make them feel comfortable enough to know that they will be fully taken care of and fully understood as they participate in this trial. That's something that we as nurses just need to continue to strive to do.

Crystal (17:09):

Yeah, exactly. Well, so great chatting with you.

Samantha (17:14):

It was great chatting with you as well, crystal. I look forward to working with you in the future and just hearing more about what you're doing and where your research is taking you.

Crystal (17:23):

Same, yeah, and I also want to thank PCNA for inviting us to talk about our research work.

Samantha (17:30):

Yes, likewise. Thank you so much. I'm so grateful to be here and to have had this opportunity.