Emily Rencsok: But even after these ethical standards for clinical trials have strengthened in the United States, the medical system has continued to systemically offer less and worst care to patients of color from structural level things, like I mentioned, such as decreased access to clinical trials or decreased access to care in general.
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Joel Nowak: Hello, this is Joel Nowak from Cancer ABCs. Today, we'll be talking with Emily Rencsok who is the first author of a just published paper about the lack of racial diversity in prostate cancer clinical trials, a really important issue with major implications for prostate cancer research and prostate cancer patients.
Emily is a fourth year M.D. Ph.D. student in the Harvard MIT M.D. Ph.D. Program. She completed her undergraduate degree in biomedical engineering at Johns Hopkins university in 2016 and spent a gap year before medical school working for Baltimore Core and Thread, organizations working towards social justice in Baltimore.
She has completed two years towards her medical degree at Harvard Medical School and she is a rising second year in the population health sciences Ph.D. Program with a specialization in epidemiology at the Harvard T. H. Chan school of Public Health. Emily's work focuses predominantly on the racial disparities of prostate cancer.
She also has broad interests in patients' experiences with health care systems and diversifying clinical trials.
Welcome Emily, I really appreciate your taking time today in having this podcast with me.
Before we actually dive into the specifics of your research, and since we are going to be talking about diversity within clinical trials, I think it's important that everybody understand the nature of clinical trials, and also, why they're so important.
So, I'm wondering if you could just take a few minutes, and talk to us about that.
Emily Rencsok: Sure, so clinical trials are the gold standard way to assess different medical treatments or diagnostic practices, basically anything that patients experience in the medical system in a standardized way.
This was predominantly done in the treatment setting through randomized clinical trials, where patients are randomized to one treatment or the other, or control.
You can also do more observational studies that can lead to similar sorts of results and conclusions and also things like registries, where patients are part of a long-term cohort, and are of followed up over time, but aren't necessarily receiving treatments one way or the other as part of the trial.
This is a great way to get patients involved in cutting edge medical research in a way that can benefit potentially both the patient directly, as well as the larger healthcare system and patients that follow.
Joel Nowak: Would it be safe to say that clinical trials are truly the backbone of our being able to make movement forward and better understanding prostate cancer in developing new treatments?
Emily Rencsok: Absolutely.
Joel Nowak: I want to drill down a little bit into some of your findings.
Maybe before I do that, if you could just give a really rough overdraft of what your findings were and perhaps even why they're so important.
Emily Rencsok: Sure, so the goal of this study was to assess both the reporting and the representation of different races and ethnicities in prostate cancer clinical trials. We reviewed 72 clinical trials, phase three and phase four prostate cancer clinical trials, to determine what was the reporting of race and ethnicity categories in these trials in terms of the participants, how many participants were in each racial and ethnic group and we also looked at over time, has the proportion of patients of color changed or stayed the same in these trials. We also looked at geographic representation of trial centers as well. So where around the world were trials being included or were clinical trial centers being included in these studies?
So, we looked at 72 phase three and phase four, prostate cancer, clinical trials, and some of the interesting results that we found where that 59 of these trials had race and ethnicity data available out of the 72 that we included in the study and 11 of these trials also had separate ethnicity data.
And then if you dive down into what categories were being represented, 29 different categories were reported, so that just shows the inconsistency in what groups are being even potentially included in these studies. Then in terms of sort of the meat of the study how many patients are included in each of these racial and ethnic categories.
So, we looked at treatment prevention and screening studies separately.
Treatment ones are essentially your stereotypical randomized controlled trial, where patients are receiving either treatment or placebo or a variety of different treatments. Prevention trials were trials that aim to prevent prostate cancer in the first place and then screening trials we're looking at diagnostic practices and how it's determined that men have prostate cancer.
For each of these groups, we found that in the treatment trials, 83.4% of participants were white and 6.7% were black. For the prevention trials, we found that 84.6% of the participants were white and 8.5% were black. And then for screening trials, we found that 97.5% of participants were white and 0.5% were black. For all of the other racial and ethnic categories that were included, Asian American, Indian, or Alaska, native, native, Hawaiian, or other Pacific Islander, Hispanic or Latino, more than one race, et cetera, they were all less represented than both the white and the black patients in all of the studies.
So, that just shows that over 80% of participants in these trials are white, which is really disappointing when we know that the burden of prostate cancer, in terms of both men getting prostate cancer and dying from prostate cancer, is happening predominantly in black or African American men.
One more thing that I'll mention is over time we looked at the proportion of races and ethnicities in each of these trials. And we found that consistently, the non-Hispanic white group had representation above 80%, which is sort of frustrating as we know, more and more about the racial disparities of prostate cancer. Seeing these numbers remain so high and so disproportionate is definitely something that needs to be worked on.
Lastly, I'll mention that for the geographic representation of the trials, we found that only two out of the 67 countries in Africa, in the Caribbean, wherever included in these trials, which is something that people probably assume but, the extent to which this was the case was really disappointing since African and Caribbean medical centers are seeing large proportions of these patients of color, and often patients in these regions have more severe disease than in the United States in Europe as well.
Joel Nowak: Those are really amazing statistics, but I'm going to ask you a question.
We're all human beings, whether we're Latino, whether we're Caucasian or whether we're African-American. So, is this really matter that we have such disparities in the clinical trial populations?
Emily Rencsok: Certainly, so clinical trials across the board, not even just prostate cancer or cancer broadly, but across all diseases, are pretty well known to be representing most commonly non-Hispanic, white populations.
And this is an issue because like I mentioned, this is the gold standard to determine how diseases work and how treatments work in various population. If we're conducting research on only these non-Hispanic white populations or predominantly these populations, we're figuring out what works well in these groups were figuring out what treatments work the best or figuring out what diagnostic practices work the best.
And we're totally excluding groups that could have an entirely different experience. So by including patients of color in clinical trials broadly, specifically in prostate cancer clinical trials, where we know that these men of color have much higher incidence and mortality from prostate cancer compared to their non-Hispanic white counterparts.
It's really important to include these men so we know how prostate cancer works in them and how these different treatments affect them and what screening practices would make sense for them. By including them were essentially working towards ensuring that all of the men included in the trials and all of the men who have prostate cancer more broadly are able to receive care that will best work in their patient’s subpopulation.
Joel Nowak: It would be my understanding that we're making decisions across the board based on sampling of just Caucasian men. This was particularly interesting for me when we talked about prostate cancer screening trials.
And, I think I saw a number in the publication that said 97.5% of the participants were Caucasian. Yet, we do have screening policies that that differ between Caucasian and African American men. So, we have this very small population of African American men, what does that actually mean for the African American man and the screening issues that they're going to face?
Emily Rencsok: Yeah. So, this was really interesting, over past decades we've seen these revamped guidelines from a bunch of government agencies in the United States saying, this is what screening practices should be and it's been changing more frequently for men of African descendant and for non-Hispanic, white men.
Like you mentioned, we found in our study that 97.5% of the participants in screening trials were white men. So how are people, how are these agencies actually determining what these guidelines should be, especially for black and African American populations that are inherently not included in these studies.
It's definitely something that needs to be addressed. A lot of these screening trials are very, very large populations. Hundreds of thousands of patients and it's really important to ensure that these populations as well, in addition to your stereotypical treatment and prevention trials are representative because as you mentioned, these guidelines are changing so frequently for men of African descent.
Its really unclear what data is driving these decisions or why one screening practice could be better than the other. So, it's really important to include these men across all types of clinical trials, not just treatment trials.
Joel Nowak: So, we really are doing a major disservice and perhaps harming people when it’s not necessary.
I would like to think that we are getting better over time with inclusion, bringing more men of diverse background into our clinical trials. What is going on? Are we doing that successfully or not?
Emily Rencsok: In our studies, we looked at the start date of each trial and bucketed it into five-year categories to see if the proportions of these races and ethnicities were changing across time.
We found that it basically wasn't changing at all. One caveat here is that in the 2015 to 2019 start date time period, don't yet have publicly available results because trials have at least a year to report their findings to the clinical trials.gov website. And also, there are a bunch of exceptions in terms of delaying results reporting are only reporting partial results. Also, in a lot of the studies that we looked at, the race and ethnicity was not available because this FDA final rule guideline wasn't in effect until 2017, which actually didn't require studies to report race and ethnicity of participants until 2017 or later.
So, this is something where we're really going to see, I hope, a lot of changes moving forward now that the final rule is in effect as of 2017 and clinical trials are going to be required to report race and ethnicity in their findings. And also, as we start to see some of the preliminary results from trials that have started recently.
I'm really excited that, hopefully we'll be able to both have more of this data available and be able to work with it in a more transparent and thorough way.
I think it's a little hard to tell in most recent years, if this has changed, A lot, but moving forward, giving more results from trials that have started recently and this FDA final rule that hopefully we'll be able to, to make a better call in coming years,
Joel Nowak: I know you mentioned in the study that, the vast number of trials, I think you said about 80% of the trials, were funded by industry. Industry meaning the pharmaceutical companies and the other 20% for the most part was funded by government agencies.
I do work with, the DOD on funding, prostate cancer research and some clinical trials. I do know that we make a lot of effort and take a lot of time looking at racial issues and disparity issues to make sure that the stuff that we are funding will in fact work to become more diverse.
I think the article referenced that this has not been the historic case of industry trials, but with the new FDA regulation, is that going to not be a concern as we move forward since they are funding 80% of the trials?
Emily Rencsok: Right, so I think this is an interesting point that you bring up. We used to live in a world where research was predominantly government funded and publicly available. Now a lot of the research as we found in this study, 80% are funded predominantly by pharma and industry.
So, it's really interesting to consider the different implications of FDA guidelines in terms of both the collection of race and ethnicity data for the participants in the trials, as well as the reporting of it.
I'm certainly not an expert in the collection and reporting guidelines for race and ethnicity data, but it's my understanding that anything that is reported to clinical trials.gov, which includes most of the industry trials as well, will fall under this FDA final rule guidelines where they'll have to report race and ethnicity as well.
So I think, especially for industry and pharma, it’s important to keep an eye on that given the high proportion they're funding these days, it's really important to keep an eye on them and push industry and pharma to include diverse patient populations, both through these government regulations, and also trying to figure out whatever sort of organic ways we can get industry and pharma to, care and prioritize having diverse patient populations.
Like you mentioned, a lot of the government centers and agencies do.
Joel Nowak: I gather that the regulation that the FDA passed has nothing to do with requiring diversity or even requiring that there are efforts to be more inclusive. Is that correct?
Emily Rencsok: Yeah. So, this is one of the main sticking points with this FDA final rule is that there's sort of collection and reporting as required, but there isn't a whole lot of guideline or oversight in terms of are trials actually meeting these benchmarks. So, a lot of recent articles have come out from people running clinical trials saying we don't really know what it means to have a diverse population.
How do you set your benchmarks? There are a bunch of different ways to determine what is a representative population. Is it the entire population in the region that you'll hopefully be serving with the treatments or outcomes from the clinical trial. Is it based on the proportion of men who have the disease versus not? Is it based on something else?
So, there's definitely some flexibility in terms. What do these populations actually mean and who is actually checking to make sure that these trials are meeting these benchmarks?
Joel Nowak: I'm going to go out on a limb here and put some pressure on you. Do you have any ideas or thoughts as to how we can proceed to make sure that industry and government is more responsive to this issue?
Emily Rencsok: I can talk specifically from the perspective of the Ironman study that I'm a part of for this study we just released,
I don't know how to pressure government or industry aside from calling your policy makers and making other people aware of the issue.
I think that one of the big issues in clinical trials is that people call for representative and diverse patient populations that they recruit at predominantly non-Hispanic white serving medical centers, which is a little bit mind blowing. These centers are ones that already have clinical trial infrastructure built and already have providers who are willing to recruit for the trials.
And it's very easy, not very easy, it’s always difficult to conduct clinical trials, but there's many fewer barriers to recruiting at a lot of the hospitals or medical systems that serve predominantly non-Hispanic white patients then if you were to try to recruit at clinical trial centers that predominantly serve patients of color.
There've been a bunch of studies that have shown that hospital systems that serve predominantly non-Hispanic white patients have more clinical trials offered than hospital systems that predominantly serve patients of color. This was a very systemic issue where if you're enrolling patients from these non-Hispanic white medical centers, how are you possibly going to get a diverse and representative population? Many patients that we want to enroll in these trials for diverse and representative patient populations are not seeking care at the centers that are involved in these trials in the first place. So, I think broadly, we need to ensure that not just patients are well represented in these studies, but that hospital systems on a larger scale are represented in these studies.
Joel Nowak: That would be really important.
I know that when we are offering clinical trials, it's still difficult to recruit minorities into these trials.
There are obviously barriers, and I'm wondering if you looked at some of the barriers and can describe some of them and then perhaps even talk about what we could do to remove some of these barriers so that when we do have clinical trials, both in these predominantly white medical centers as well as in centers that are serving a more diverse population that we can be more successful in recruiting.
Emily Rencsok: Sure. So, there are definitely barriers that disproportionately affect patients of color compared to non-Hispanic white patients. This is pretty extensively reviewed in the literature, but I'll just point out a few of the more common ones.
One common barrier that I've seen talked about is low levels of knowledge and awareness regarding clinical trials. This can occur both on the individual and hospital system level. So, it's been shown that providers are less likely to offer trials to patients of color than compared to non-Hispanic, white patients. Also, that hospitals that predominantly serve patients of color have fewer open clinical trials in general, compared to the hospitals, mostly serving white patients.
So, on the patient level would be continually advocate for yourself and ask your providers about open clinical trials at your institution.
In terms of the hospital system level, patients can be advocates in terms of trying to get their hospitals to be involved in clinical trials, if they aren't already both at the policy level and also talking to their providers about it.
I think providers are in a really unique position to influence policy and make sure that, various clinical trials and their connections to others at other institutions who are running clinical trials are able to bring that health system into the mix and get them enrolling patients in the clinical trial as well.
Joel Nowak: The fact that providers are not offering their African American or their racially diverse patients’ information about available trials, what do you attribute that to?
Emily Rencsok: So, I think this can come down to essentially manifestations of a lot of implicit biases.
'll tie in another barrier to participating in clinical trials for patients of color things outside of the hospital system that disproportionately affect patients of color.
It takes a lot to participate meaningfully in a clinical trial, you have to be able to get to the clinical trial center reliably.
You have to be able to take days off of work or time off of work to make sure that you can go to your follow-up visits. You have to make sure that if you have kids, they have childcare so you can go to the hospital or that the hospital is accommodating if you bring your kids there.
Things like lack of transportation and childcare and inability to leave work for appointments are things that can influence the ability to participate in clinical trials that are more commonly issues for patients of color compared to white patients.
So, I think that one sort of manifestation of implicit biases in medical care from providers is seeing these statistics and thinking, Oh, my patient of color, won't be able to get to the hospital reliably or, Oh, they won't be able to have someone take care of their kids so they can come in. So, they just offer the trial less to patients who are white, who typically have more stable transportation, jobs that let them take time off of work to go to the appointments and whatever else they need to participate. I think that one of the reasons that the trials are offered less to patients of color is just flat out provider bias, thinking that they won't be able to participate anyways even if the trial is open.
Joel Nowak: Is there any way we can build into trials ways that can perhaps be more supportive of patients so that they can get over some of these barriers, parking, extra appointments, childcare, things like that, that you've mentioned.
Emily Rencsok: I think it would be lovely if trials could and wold offer that.
I think another big thing for clinical trials is previously clinical trials have been very heavily location focused. So, you have to go to the hospital to get this done. You have to go to the hospital to do the follow-up appointment. You have to go to the hospital to get the treatment. You have to go to the hospital for all of the aspects of the clinical trial.
If we, could figure out which I think some trials are doing in recent years, how we can push towards more remote clinical trials. I think that given the current state of COVID-19 and a lot of providers and care in general, moving towards telehealth and telemedicine it could be really interesting for the future of clinical trials.
Are there ways that we can make these trials more remote or parts of the trials more remote in terms of follow-up visits or things that aren't necessary to go to the hospital for? Or are there ways that we can involve patients that way? So, if they're at home with kids and don't have transportation to get to the hospital, they can still meaningfully participate in and be important patients in these clinical trials.
Joel Nowak: Wouldn't that be nice if we get something positive come out of the covert virus.
Emily Rencsok: Absolutely.
Joel Nowak: One of the things that you mentioned earlier in our conversation was the lack of involvement of clinical trials outside of Europe and the United States. Isn't this a way to increase diversity and if you increase diversity for people who live in African countries, does that actually reflect African-American men or are there differences that we would then need to consider?
Emily Rencsok: Yeah. So, I think that making clinical trials more equitable globally, not just within the States is very important. That's why we were curious to do this global representation part of the study that we published a couple weeks ago.
I mentioned, we found that only two out of 67 of the African and Caribbean countries in the world, we're in included in these prostate cancer clinical trials that we looked at, and these centers are obviously serving very predominantly patients of color or U.S. Minority patients.
By including these centers in these clinical trials, you're both including representative patient populations, and you're also helping to build up the medical infrastructure and regions that have typically been underrepresented or haven’t had much investment in, in the past.
In terms of the translation between black men in Africa and the Caribbean regions and black or African American men in the United States, this is a very dicey topic.
Obviously race or being a black patient in the United States can mean something very different than being a black patient in Africa or the Caribbean. I think those are all important things to consider when opening trials in these regions and I think that even if we can't draw specific parallels between African and Caribbean men and black men and African American men in the United States, it's still certainly worthwhile to involve these men in these clinical trials. So again, they can participate in research and help figure out what is the best care that they can receive as well.
Joel Nowak: We know that Asian men who are living in Asia tend to have a lower incidence of prostate cancer, but as they come into a Western society those numbers change, we’re not quite sure why. That would be a factor that we would need to think about when you try to compare clinical trials of men participating in different countries, would that be the case?
Emily Rencsok: Absolutely. And we also know that in regions like Africa and the Caribbean, black men are presenting with much more advanced disease than they do in the United States.
That could be attributed to a whole bunch of different things like different screening practices or beliefs about the disease or a whole host of other things and is the disease progressing more quickly or differently in patients in Africa and the Caribbean versus the United States?
I just think there are so many interesting questions where the answers would ultimately benefit patients around the world if we did conduct research in these regions and allow men in Africa and the Caribbean to participate in prostate cancer clinical trials.
Joel Nowak: Your discussion about Hispanic mortality rates for prostate cancer really surprising. Can you tell us a little bit about what you found?
Emily Rencsok: This is a very important thing. We spend a lot of time talking about white versus black, but there are so many other races and ethnicities that should also be included in clinical trials at a proportionate rate.
We know that in recent years Hispanic and Latino populations in the United States are growing and becoming a much higher proportion of the United States population. We also know that Hispanic and Latino populations have higher mortality and incidents from prostate cancer compared to white populations as well. So, it's really important to consider in the changing landscape of the United States, the racial and ethnic composition of the United States that we're including men who are reflective of the United States population and disease incidents as we continue to conduct clinical trials. This is definitely not just a black versus white issue. As you mentioned, Hispanic and Latino men do have these disproportionate clinical outcomes as well. So, it's very important to include them.
And then also, as you mentioned, why do men of Asian descent with prostate cancer seem to have less prostate cancer in the first place or less severe prostate cancer, lower deaths from prostate cancer?
It's really important to include those men to figure out why Asian populations are protective compared to these other groups?
Joel Nowak: I think you've mentioned that the mortality rates in Hispanic men are surpassing Caucasian men. There are clearly changes going on and it would be nice to know what that's all about.
Emily Rencsok: Yes, absolutely very important to include [Asian] men in trial so we can start to figure out answers to some of those questions.
Joel Nowak: One of the barriers that you didn't mention within the African American population their willingness to join clinical trials, has to do with history. I think that that still is very much an issue. I don't know whether you found that in your research.
Emily Rencsok: Yea, So, this is another barrier that I was going to bring up in patients of color having negative attitudes towards clinical trials in the medical system in general, especially in the United States, which as you mentioned, has deeply historical roots in studies like the Tuskegee and Guatemala, Syphilis studies that are now familiar examples for ethical breaches and clinical trials, specifically targeting people of color.
But even after these ethical standards for clinical trials have strengthened in the United States, the medical system has continued to systemically offer less and worst care to patients of color from structural level things, like I mentioned, such as decreased access to clinical trials or decreased access to care in general to more patient level manifestations of implicit bias from providers leading to things like pain, not being taken as seriously for black patients compared to their white counterparts or a lot of the things that have been in the news recently about black women having higher mortality during pregnancy than white women.
So, it's something that definitely needs to be acknowledged. I think that these sorts of issues, these historical systemic different treatment practices of patients of color versus white patients in the United States is something that really needs to be addressed in medical education, from all levels of providers, not just physicians, but also nurses and PAs and everybody who is involved in the care of patients.
I think it's really important to come up with specific anti-racist ways to inform future providers about how to take care of patients in a meaningful and equitable way.
Joel Nowak: I actual l think that this particular concern of bias about how people of color are treated not only extends to clinical trials, but it also extends to treatment recommendations.
I received a phone call a short time ago from a woman who was diagnosed with uterine cancer. She felt that her doctor was recommending radical treatment, and her concern was that the doctor is going to be experimenting on her.
So, not only do we have concerned about clinical trials, this whole thing permeates to treatment or to concern for treatments. That's something I found pretty stunning.
Emily Rencsok: Yeah, absolutely. And I think it's really important for patients to feel comfortable voicing these concerns to their providers and for providers to feel comfortable engaging in these conversations with their patients.
I think that that's something, again, that can be incorporated into medical curricula where the sort of vulnerability and openness and acknowledgement of these historical mistreatment of patients of color in the United States is something that's really important to inform providers and make them comfortable enough to engage their patients in these conversations.
Joel Nowak: Are there other barriers that we haven't discussed yet?
Emily Rencsok: So, those were sort of the main three that I was thinking of is sort of the lack of knowledge and availability of clinical trials for patients of color. And then also these negative attitudes and beliefs towards the medical system in general, not just clinical trials specifically, and then also the structural barriers outside of the hospital system that are really important to take into consideration as well.
Joel Nowak: You also mentioned the Iron Man Study or the Iron Man Registry. Could you share with us a little bit about that study? It's an important study and obviously men who have prostate cancer will be listening to this podcast, if you could talk about that study and perhaps encourage people to participate, and also how it's speaking to the issue of diversity.
Emily Rencsok: Ironman is the international registry for men with advanced prostate cancer. This aims to be a global registry for men with advanced prostate cancer that includes this diverse and representative patient population. Basically, how the study works on sort of a high level is that men with advanced prostate cancer are enrolled into Iron Man and then they're followed up for years to see how does their treatment change, what sorts of side effects do they have? Do they have any sort of serious adverse events, basically just following these men and keeping an eye on what their experience is like? We also ask questions about quality of life and other symptoms that are sort of not prostate cancer specific.
We're really interested in broadly learning about the experience of a diverse patient population that has advanced prostate cancer. And like I mentioned, this is a global study. So we're really interested in enrolling patients, not just from within the United States and Europe as is typically the case with clinical trials, but in particularly underrepresented regions.
So we have a diversity working group to speak towards these, diversity related issues that has people working with Iron Man specifically focused on are we meeting benchmarks for including diverse and representative patient populations? What are new and innovative ways that we can ensure that men of color are able to participate in this registry.
We're about to start low- and middle-income country working group as well, which is really going to focus on the global representation aspect that we were talking about before and trying to enroll men in regions and Africa and the Caribbean and Latin America as well.
One thing that we're really excited about is our recent partnerships with the African Caribbean Cancer Consortium and the Prostate Cancer Transatlantic Consortium, which have centers in the United States, but also work really closely with centers in Africa and the Caribbean.
We've been building relationships with them over the past couple of years, visiting sites in Nigeria and also Jamaica to figure out the feasibility of including these hospital systems in the Iron Man Registry and allowing men in these regions to participate in this study. We're really excited that it seems like it's going to be possible to involve these hospital systems and start getting up and running and enrolling these men. So we're really looking forward to seeing the fruits of this collaboration between Iron Man and these two wonderful groups to insure that men all over the world, especially in these underrepresented hospital systems and regions can also participate in the Ironman Study.
Joel Nowak: Do you think that what is happened in iron man can serve as a model for other clinical trials?
Emily Rencsok: I hope so. We're not trying to go into these regions like we have all of the answers and know exactly what's going to work, because that is certainly not the case. All of the community members and providers that are living in these regions know more than we will ever be able to know about their regions and their patient populations and how Ironman could look at these centers.
We've really been trying to go in to these regions and build relationships in a really meaningful way and just learn from what they have to tell us and how we can best support them in running the Ironman study and enrolling patients into the registry. So, I think it's really important for clinical trials, when they are working in this space to not assume they know everything or know exactly how it's going to work and to really listen to the people that you're trying to engage in partnerships for the trial or for the patients in general. I hope that clinical trials in general can take this model of forming really organic relationships with communities and learning how to conduct research on participants in a meaningful and ethical and supportive way versus the past issues we mentioned, where clinical trials just go into communities of color, underrepresented communities and do whatever they want.
Joel Nowak: You’ve been nurturing these relationships over an extended period of time. is this actually a potential model for other trials, which are much more time focused comparing one drug to another, not longitudinal types of studies or trials.
Emily Rencsok: Yeah. I think it's really important to consider what each trial protocol outlines for the patients.
I think an interesting challenge for regions like Africa and the Caribbean is the long-term follow-up. We're concerned about how often these men go back to the hospital for care, or if they move around and we can’t find their address or they don't have a cell phone so we can't call them.
I think the longitudinal nature of Iron Man presents unique challenges to working in these regions. A single time point or shorter time period trial in these regions might be a little bit more feasible.
On the other hand, the Iron Man registry isn’t giving them specific drugs or treatments to treat their disease, whereas other clinical trials that are treatment focused would. The men would need access to this treatment and the hospital centers would need access to this treatment. That's another set of challenges.
So I think it'll be really interesting to explore how each type could work in these regions. But I really do think that there is a lot of infrastructure that's already been built within Africa and the Caribbean that is not particularly challenging to tap into. And that could really, be built up into incredible U.S. Class institutions if given resources from the United States and investment from countries around the world.
Joel Nowak: Well, it gives us something to work towards.
The Iron Man study, is really important. Can you, tell people how they may find out more about it. I know we have to have metastatic prostate cancer. In this case, what metastatic prostate cancer has been defined as, and then how they would actually consider learning about how to participate. it's a really important trial.
Emily Rencsok: Yeah. So, like I mentioned, we're interested in men who have been diagnosed with advanced prostate cancer.
We have a bunch of sites open in the United States and quite a few open abroad as well. But if you want to learn more about our locations or what it actually means to be part of the Iron Man study, you can go to Iron Man registry.org, and there's a lot of information there about who we are, there's some information on the diversity working group as well and yeah, like I mentioned some information on different locations and how to get involved.
So I think that would be a first step. And then if you're interested, you can reach out to your provider, if it's open in your center. Also, you can sign up to be on our email list serve so you can be kept up to date with Ironman updates as well.
Joel Nowak: If your provider is not associated with a site that has Iron Man, that doesn't preclude you from participating, is that correct?
Emily Rencsok: Yeah. So, you would need to be enrolled in the trial from one of our participating centers. So, if there are regions close to you that are participating you could go there and get involved. Again, I think it's just important to look at the locations and see would this work for you? And again, like I mentioned, we're opening up new centers continually, so keep an eye on where we are located, and hopefully you can get involved.
Joel Nowak: Terrific. So, I've gone over a number of my questions. I'm wondering, what I have not asked you about that's important in your study.
Emily Rencsok: I think you covered most of it.
One thing that I will mention that was interesting, just in terms of the methodology of this study, was how difficult it was to get the race and ethnicity information on each of the patients. Only 32 of the trials had race and ethnicity data available on clinical trials.gov. For a lot of the other studies we had to dig around in published papers or random FDA documents or email the authors or put in data requests from pharmaceutical companies, so just the extent to which we had to go in order to get race and ethnicity information on participants in general, I thought was pretty shocking.
This goes back to the FDA regulations that I was talking about before, where it’s required for clinical trials to both collect and report race and ethnicity information. So I hope that that will be less of an issue moving forward, but was definitely shocking to see just how hard it was to see what race and ethnicity the patients were.
Joel Nowak: I really would like to, again, thank you so much for the time you spent. I think that your findings were stunning. I think they were surprising to me and I think they will be surprising to a lot of people as to how significant, the disparities are within our trials. I think this is important that people talk about it and become more aware and we work a lot harder to correcting the situation.
I also want to not only thank you for your time, but I also want to really wish you continued success with your studies and also with this important research and I'm looking forward to speaking to you again about your next paper and so thank you again. I truly appreciate it.
Emily Rencsok: Thank you so much. And thank you for giving this issue a platform. Like you mentioned, I think that's very important that we acknowledge that these disparities do exist in order, to move forward with fixing them and ensuring that men across the world can receive equitable care.
Joel Nowak: Terrific, this has been Joel T Nowak for Cancer ABC's along with Emily Rencsok. We have been talking about her recent publication about diversity, or I should say, the lack of diversity in prostate cancer clinical trials.
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