Medicine must create inclusive clinical trials [PODCAST]

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“Researchers should make clinical trials more accessible by providing patients with simple explanations of studies at a variety of locations, including community clinics and medical centers. Increased flexibility regarding transportation and visit timing is essential. Researchers should also allow the participation of people who do not speak English and those living with chronic conditions whenever it is safe to do so. If the treatment will be approved to use on these populations, it is unethical to exclude them. These are considerations that researchers must think about not only when designing COVID-19 studies, but all clinical trials, as this is essential to reducing health care disparities overall. Moving forward, we must put fairness and our patients’ safety above increased cost or administrative burden; perhaps this is how we begin to make amends for the atrocities of the past.”

Amelia Trant is a medical student. Andrea Silber is an oncologist.

They share their stories and discuss their KevinMD article, “Medicine must create inclusive clinical trials.”

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Hosted by Kevin Pho, MD, The Podcast by KevinMD shares the stories of the many who intersect with our health care system but are rarely heard from.

Transcript

Kevin Pho: Hi, and welcome to the show, where we share the stories of the many who intersect with our health care system but are rarely heard from. My name is Kevin Pho, founder and editor of KevinMD. Today on the show, we have Amelia Trant and Andrea Silber. Amelia is a medical student, and Andrea is an oncologist. Together, they co-wrote the KevinMD article “Medicine must create inclusive clinical trials.” Amelia and Andrea, welcome to the show.

Amelia Trant: Hi, Kevin.

Kevin Pho: All right. We’ll get into your article in a little bit, but first off, I’m going to ask each of you your journey and your story to where you got to today. Amelia, why don’t you go first?

Amelia Trant: Yeah, so I’m a third-year medical student at Yale now. I also went to Yale for undergrad, and I spent my gap year doing breast cancer research at Smilow Cancer Hospital, and that’s where I met Dr. Silber. She had such great ideas about improving care for the underserved. In undergrad, I loved my global health and public health classes, and I felt really compelled to work on projects that benefited those who struggled to get the best care. So working together was a natural fit.

Kevin Pho: Excellent. And Andrea, can you share your story and your journey to where you are today?

Andrea Silber: I came to Yale in 1981, and at that time, health disparity, justice, social justice, those weren’t terms that were in common usage. But I could tell even then that people who were poor or people who were underrepresented minorities had worse outcomes, and I’ve spent my whole career trying to figure out novel ways to make things better, at least in cancer.

Kevin Pho: All right, so let’s talk about your KevinMD article, “Medicine must create inclusive clinical trials.” Amelia, for those who haven’t read the article, can you just walk my audience through it and maybe share the story of why you and Andrea decided to write it?

Amelia Trant: Yeah, so our article was based in part on the findings of a paper that we published over the summer that was about Dr. Silber’s own initiative, OWN IT, and it stands for Oncology Welcomes New Haven into Trials. The goal of the initiative is to increase diversity in clinical trials at Smilow Cancer Hospital. Dr. Silber has made some great progress with this over the last few years through doing community outreach and focus groups and working with the institutional leadership. So the paper focused on the initiative and the results of a survey study that we did with 200 breast cancer patients about their knowledge, attitudes, and experiences of clinical trials. We also looked at the inclusion and exclusion criteria of breast cancer clinical trials that Smilow would offer.

We decided to write the KevinMD article because of everything that’s been going on in the world. There’s been such a focus on clinical trials in relation to the COVID vaccine and COVID treatments. And given that COVID has disproportionately affected people of color, and everything that’s been going on with the anti-racism movement, there’s been a lot more focus on health disparities. We wanted to draw attention to this important health disparity: People of color are underrepresented in clinical trials.

This really matters because research studies are an important part of the scientific process. Medical breakthroughs come through clinical trials, and our belief and the belief of experts in the field is that populations that are not included in research studies are not going to benefit as much from their research studies to participate. And so clinical trials can either help reduce health disparities or could perpetuate them, depending on how we do our studies.

Kevin Pho: And Andrea, what are the specific obstacles that both researchers and minority populations face when it comes to being included in clinical trials?

Andrea Silber: There are so many barriers, and we’re really trying to make a difference in working on them. One of the things is there’s a lot of time and participation in the clinic, which means that people who work in everyday working jobs can’t get off from work to participate. They need to be able to communicate with nurses during the day, to say nothing of extra expenses with transportation and child care. Our system is broken, and it needs to be recreated so that cancer care represents all people. And those clinical trials need to mirror the real world, where people work, they take care of families, and they have cancer and need to participate in clinical research.

Kevin Pho: Amelia, one of the things in the article that you and Andrea co-wrote was some of the hesitancy when it comes to outreach to minority populations, especially in the historical context. Can you briefly talk about that?

Amelia Trant: So I think there’s been a historically held belief among people in the medical system that people of color don’t want to participate in trials, that they don’t trust us because of some of the really horrible things that medicine has done in the name of science in the past to them, such as the Tuskegee experiment and the Henrietta tragedy. But I think through our research, we feel like that’s really not the whole story. There are a lot of barriers that have to do with the institution and the way that we set up our trials that are stopping people from participating, but it’s not necessarily that they don’t want to.

Kevin Pho: And Amelia, what are some of the solutions that you and Andrea describe in your paper to address some of these issues?

Amelia Trant: We feel researchers have to design their studies differently. We need to look at the inclusion and exclusion criteria and make sure that we’re not saying that people who don’t speak English as their first language can’t participate, that we’re not excluding people with chronic diseases that disproportionately affect people of color unless it’s unsafe for them to participate in these studies, and that we’re making sure that studies are accessible to everyone in terms of the language that we’re using, so that it’s readable to people who don’t have a medical education, and that it’s accessible from a geographic standpoint as well.

Kevin Pho: Andrea, you mentioned the COVID trials and how important it is to include minority participants, especially since COVID is disproportionately affecting them. So from what you know, with the Pfizer and Moderna trials, what have they done to include enough minorities in their trials when it comes to the COVID vaccines?

Andrea Silber: There was outreach, and there has been special attention with both those trials to increasing the minority population. But even inclusion in the trial doesn’t necessarily mean that everyone in the community is going to accept those results. I had a discussion with one of my patients who’s a community activist in New Haven, and I said, “You’re participating in one of my clinical trials. Will you accept the vaccine?” She said, “No way. I don’t trust the government.” And I said, “But you trust me, and that’s why you participated.” And she looked at me, and she said, “Yeah, that’s right.” So I think we have to take it out of the realm of government politics and really have a dialogue between our health care workers, trusted individuals, and the rest of the community.

Kevin Pho: We’re talking to Amelia Trant and Andrea Silber. Amelia is a medical student, Andrea is an oncologist, and together they co-wrote the KevinMD article “Medicine must create inclusive clinical trials.” Now, my last question is always going to be a take-home message, so we ask each of you the same one. Amelia, start first. What is your take-home message that you want to leave with the KevinMD audience?

Amelia Trant: Yeah, I think that we’re charged with ensuring that science moves forward at the same pace for everyone. To do that, we need to create inclusive trials, and that will be more work for us, but it’s the right thing to do.

Kevin Pho: And Andrea, what is your take-home message that you want to leave with the KevinMD audience?

Andrea Silber: It may be a little surprising, given how hard 2020 was for everyone, but there are incredible lessons and knowledge that we’ve all gained from 2020, and that means that we need to be safe for our patients and convenient for our patients. Some of those lessons can be adapted to clinical research. Do we need to bring someone in every day to conduct a trial if, in the real world, we give chemotherapy and we can do at-home visits? So my hope is that some of the things we’ve learned about how to take care of patients safely in their own communities are going to translate to better clinical trials, patient-centered clinical trials, and hopefully a situation where everyone gets the same cancer care and, more importantly, the same outcomes.

Kevin Pho: Well, thanks to both of you for sharing your time and insight, and thanks again for being on the show.

Andrea Silber: Thank you.

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