Episode: 51 - Bridging the Equity Gap in Oncology with Eugene Manley, Jr.

Are medical advancements closing or widening medical disparities? Eugene Manley, Jr., Ph.D., founder and CEO of the STEMM & Cancer Health Equity Foundation, breaks down why equity is still not completely measurable in clinical trials, what proper representation in studies is, and how certain demographics are at a disadvantage for biomarker tests compared to other groups with host Deborah Borfitz. Their conversation explores whether health equity in cancer trials is different compared to commonly occurring diseases and if basket and umbrella trials may help the move the needle. Plus, the latest news on a pioneering phage therapy service, a unique cardiac arrest pilot study, new primary endpoints for cancer trials, and trial disruptions threatening diversity. Listen and let us know in a review: where do you think our time and resources are most needed for equity? 

Show Notes 

News Roundup 

Compassionate use phage therapy 

• Article in Nature Medicine 
• Press release from Monash University   

Sudden cardiac death research  

• Study in Prehospital Emergency Care 
• News on the University of Cincinnati website 

New endpoints for cancer trials 

• Consensus paper in The Lancet Oncology 
• News on the Medical University of Vienna website 

USC and Tempus strategic collaboration 

• News on the Keck School of Medicine of USC website 

Trial disruptions threaten diversity 

• Article in the Journal of Medical Internet Research 

Misinterpreting effects of Alzheimer’s drugs 

• Research letter in JAMA Neurology 
• News from Brown University School of Public Health 

 
Guest 

Eugene Manley, Jr., Ph.D., founder and CEO of the STEMM & Cancer Health Equity Foundation 

The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News senior writer, Deborah Borfitz, welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today.  

Transcript

Welcome And What’s Ahead

Deborah Borfitz 0:01

Hello and welcome to the Scope of Things podcast, a no-nonsense look at the promise and problems of clinical research based on a sweep of the latest news and emerging trends in the field and what I think is worthy of your 30 or so minutes of time. I'm Deborah Borfitz, Senior Science Writer for Clinical Research News, which means I spend a lot of time with my ear to the ground on your behalf, and a lot of hours every week speaking to top experts from around the world. Please consider making this your trusted go-to channel for staying current on things that matter, whether they give us hope or cause for pause. In a few minutes, I'll be speaking with Dr. Eugene Manley, founder and CEO of the STEMM and Cancer Health Equity Foundation, about making equity measurable in cancer care and research. But first, the latest news, including a pioneering phage therapy service, a unique cardiac arrest pilot study, new primary endpoints for cancer trials, a learning health model integrating clinical care and research, trial disruptions threatening diversity, and a statistical method producing misleading results about Alzheimer's drugs.

Phage Therapy Meets Real-World Hurdles

Deborah Borfitz 1:07

Researchers in Australia are pioneering an end-to-end clinical phage therapy service known as VIC Phage for compassionate use treatment of challenging bacterial infections and to get involved in multi-centered clinical trials. Phage therapy was unsuccessful in treating the first patient case in 2022, a 22-year-old with cystic fibrosis, because he had pre-existing antibodies against the phage, but this discovery benefits all subsequent patients to be tested for this critical vulnerability. Methodologies, phage production approaches, and data collection from treated patients across the country are under review in a quest to save the lives of hundreds of patients suffering from life-threatening infectious disease caused by multidrug-resistant pathogens.

Cardiac Arrest Research In Real Time

Deborah Borfitz 1:52

At the University of Cincinnati, emergency medicine researchers recently worked with local paramedics to conduct a first-of-its kind cardiac arrest pilot study proving real-time blood collection is feasible and scalable. With only 30 minutes to try to revive patients, traditional clinical research was not an option. The collaborators developed kits that allowed paramedics to draw blood from 18 sudden cardiac arrest patients during treatment and then deliver the samples to the hospital where they were stored in a biorepository for later analysis. No uniform disease processes were uncovered, underscoring the need for a larger 700-patient study now planned in multiple U.S. cities to better understand the triggers and develop a point-of-care diagnostic tool.

Rethinking Endpoints For Metastasis Trials

Deborah Borfitz 2:38

An international group of experts has established new primary endpoints for future clinical trials in patients with cancer and isolated metastases that markedly departs from the previously used progression-free survival. They defined valid and patient-relevant study endpoints applicable to different cancers in a consensus paper focused on high precision radiotherapy and the stage between locally confined and widely advanced disease when a cure is still possible. Agreement was reached on two new metrics reflecting the fact that metastasis-directed therapies allow individual metastases to be treated in a targeted and repeated manner.

A Learning Health System For Trials

Deborah Borfitz 3:18

A recently announced strategic collaboration between the University of Southern California and technology provider TEMPUS AI creates a framework for integrating clinical care, research, and clinical trials into a single learning health model. The partnership spans a system-wide ecosystem for 1.5 million annual patient visits across the USC network and aims to ensure the translation of discoveries and clinical innovations into practice and access to personalized care and clinical trials. The collaboration will initially focus on precision oncology and over time extend to other specialties, including cardiology, neurology, and radiology. Clinical testing, clinical trial matching, clinical care gap pathways, and research collaboration and co-development are the four key pillars that anchor the undertaking.

Trial Disruptions Threaten Diversity

Deborah Borfitz 4:08

A new report highlights how recent shifts in federal policy and funding have impacted hundreds of trials designed to study disease burdens in underrepresented populations. In 2025 alone, 383 clinical trials were disrupted, affecting more than 74,000 participants. Over a recent seven-year period, fewer than 20% of drug trials have data irrelevant to the specific benefits or side effects for Black patients. Experts warned that failing to characterize drug efficacy across diverse ethnic groups could cost hundreds of billions of dollars and reduce life expectancy and disabilities over the next 25 years. Digital tools and community partnerships were cited as the two primary avenues for countering structural barriers.

When Statistics Mislead Alzheimer’s Findings

Deborah Borfitz 4:55

And finally, a study led by scientists affiliated with Eli Lilly has found that a statistical technique known as quantile aggregation can exaggerate the causal link between amyloid reduction and cognitive benefits of a new class of Alzheimer's drugs. The analytic method divides people into groups, averages their results together, and then looks for patterns across those groupings. The misrepresentation problem was found by reanalyzing the original data from the randomized control trial on Eli Lilly's Alzheimer's drug known as Donabimab. And in simulations designed to reflect the conditions from recent trials, researchers found the method showed the relationship between amyloid and cognition to be 29 times higher than its actual magnitude. The findings don't settle the question of how the new Alzheimer's disease drugs work, but rather highlight the need for more rigorous statistical methods. As a reminder, links to the articles, studies, and press releases referenced in this month's news segment can be found in the show notes.

Why Equity Still Lags In Oncology

Deborah Borfitz 6:01

It is now time for today's chat with Dr. Eugene Manley, a PhD-trained molecular and translational cancer biologist about advancing equity in cancer clinical trials by addressing the persistent biomarker gap. Welcome to the show, Dr. Manley.

Eugene Manley, Jr. 6:18

Thank you for having me on. It's a pleasure to be here, Deb.

Deborah Borfitz 6:20

Well, I'm so happy to have you join us today. You know, as regular listeners are aware, I have had several guests on the podcast over the last few years with a passion for creating health equity in clinical trials. I'm curious, Dr. Manley, if the situation with cancer is different than any other commonly occurring disease, be it hypertension, heart disease, diabetes, respiratory infections, mental health disorders, you name it. When it comes to having the proper representation of different populations in studies, what's your take on that?

Eugene Manley, Jr. 6:54

Unfortunately, I would say there is not much fundamental difference. We still see underrepresentation of black, Hispanic, indigenous, rural, low-income, immigrant, and medically underserved communities in trials and biomarker testing and access to care. If we think broadly, we could say, you know, cancer research determines who gets access to the newest treatments. However, many patients aren't offered clinical trials. And so if they aren't offered the trial, how do they know it's going to work? We know that cancer specifically has really been driven by biomarkers, in particular since the discovery of EGFR in the early 2000s, it has drastically driven precision medicine and lung cancer. And now we have 10 biomarkers. However, not everyone is getting offered biomarker testing. And then it's not just about the trials. The people are never asked about the trials, you know. And then, you know, there are other barriers that people face when they're trying to engage trials. You know, is it transportation, pay time off, childcare? These are other factors that all combine to make it harder for these underserved communities to access trials. Yeah, it's sad to hear that that the situation is so, I guess, widespread and the breadth of it is just the same everywhere. in oncology specifically, though, it would can we say the central problem is that many current medicines are biomarker-driven targeted therapies these days.

Eugene Manley, Jr. 8:35

And yet the flip side is that only a subset of the overall population of people with any sort of cancer are getting this, you know, molecular sequencing or liquid biopsy tests to identify them as good candidates for these new investigational treatments. And maybe that's a bit unique to cancer. I think, yeah, that is part of it. You know, like I said, in oncology, you know, and lung, like I said, we have about 10 biomarkers that are currently used for the, you know, that we can test for and we have therapies for. But it's hard to benefit from the precision medicine if you've never been tested for, you know, comprehensive biomarkers or NGS. You know, typically a person is only, if you're lucky, you may only get one to three of the biomarkers done for lung cancer and a test, unless you are well off in a fluent and have great insurance. Otherwise, it's hard to get the rest of those tests. But then when you don't get all those four biomarkers tested, then you might be missing a chance to get a therapy that could actually delay on, you know, delay progression of your disease or treat it. And the problem is, you know, when you think about these black, Hispanic, underserved, medic, medically, underinsured, and uninsured, they're less likely to get the testing, they're less likely to be at the big major centers which have this major infrastructure to do these comprehensive testing. And I think, according to the ACCC, it was in community care that more than 70% of lung cancer patients will not receive biomass marker testing according to the guidelines, and more than 50% do not receive precision medicine based on those test results. And Medicaid patients have been reported to have 40%, have been reported to be 40% less likely to receive testing than privately insured patients. So it's, you know, access, affordability, and equity really driving the challenges.

Making Equity Measurable With Better Data

Deborah Borfitz 10:42

Yeah, yeah. And I think in a prior conversation, we were talking about the importance of making equity measurable. And I think that's sort of the chief conundrum here, like how best to go about that. And so we can you can't address a problem if you don't acknowledge it, I guess. And I know we can track enrollment demographics, use performance metrics to spot where disparities exist, evaluate treatment efficacy by population, and the landscape of clinical trial funding has also shifted heavily to favor health equity, at least in some arenas. So why is this still a problem? And what what do you think we need to do to fix it, to make equity you know measurable and therefore addressable? And and sort of whose job is it?

Eugene Manley, Jr. 11:24

Well, I think it's it really has to be a broad systems approach to address it. If only one person at the org cares and they're not in leadership and driving the decisions, then nothing's going to funnel down to the rest of the people. So I think you know, we have to think about just in non-small cell lung cancer. We had next gen sequence was only performed in 50% of white patients compared to 39% of black patients. Testing before first line therapy was lower for black patients, like 29.7 compared to 36.6 for white patients. And if you think about clinical trial participation, you could take any of a number of studies. Enrollment for black participants is about 3 to 4% if you're lucky. And sometimes Hispanic populations are 6%, but these do not remotely reflect the populations with the disease incidence or rates. So some things you can do is look at, you know, tracking who was diagnosed, who was eligible for biomarker testing, what they were offered, what they received, if it was a narrow panel, or if it was comprehensive NGS, and whether the sample failed, and then looking at how long it took to get the results back, and then how long you did treatments following that.

Eugene Manley, Jr. 12:52

Secondly, you want to get real world data from these communities because the people in the real world are never the population that's in your trial. You know, your trials have inclusion exclusion criteria that they kind of want everybody to be fit and perfect. But we know that in the real world, people are older, they have comorbidities, they're in community settings, they don't have resources. So if your never evidence-based doesn't look like the patients that are really going to get treated, that's a barrier. And then I think we have to think about broadly about diversity, which is not exactly a great buzzword right now, but not just in the clinical trials. We have to think back as far as early as the cell lines, because you know, I have done some stuff that we showed across the 800 plus lung cancer cell lines, there were only 30 cell lines from black patients, none from Hispanic, none from American, Indian, Alaska Native, and there are about 390 from Asian, 200 from white. But the problem is if that's our starting cell lines, and we only have one non-small cell lung cancer that was from a black person, and you know, typically cell lines are where we start to do our preclinical testing to, you know, do target validation. If our cell lines don't even reflect the patients and populations with the disease, then we're already starting at a deficit when we try to proceed to a clinical trial. And then you go do a clinical trial where you have a non-diverse trial team, a non-diverse trial site. The patients don't feel seen, they're still racially discordant interactions in healthcare. And then the patients are like, Well, why do I want to be here?

Eugene Manley, Jr. 14:35

And so you get to the trials, and then there's lack of representation, and then you get this data and say, Oh, we have this great target. And then you have to get the post-market analysis that, oh, we're missing a group, or these black populations might have different immune adverse events. So you really have to build this stuff in from the beginning. And I think we need to do more, give more funding and resources to community oncology practices because that's where the bulk of the people are.

Announcement 15:04

Are you enjoying the conversation? We'd love to hear from you. Please subscribe to the podcast and give us a rating. It helps other people find and join the conversation. If you've got speaker or topic ideas, we'd love to hear those too. You can send them in a podcast review.

Deborah Borfitz 15:22

Yeah, wow. And I'm not sure there's even a role here for this. Now you've settled that, but let me ask anyway.

Master Protocols Help Only If Included

Deborah Borfitz 15:27

master protocol designs like basket and umbrella trials where biomarkers are tested across different tumor types or multiple treatments within one cancer type, you know, so more patients are matched, regardless of the mutation or cancer subtype. Could this help move the needle in favor of better health equity in any measurable way, given sort of the background problem?

Eugene Manley, Jr. 15:50

Well, on the one hand, you you think about it, you know, basket and umbrella trials can help because they reduce, you know, fragmentation. So, in the one hand, instead of opening a trial for every single drug, mutation, and subtype, a master protocol really allows one shared infrastructure across the site. And this can make it easier for patients to be tested once and then matched to an arm, which I think really is going to move the needle. I mean, I think two examples are the NCI match trial, where they were looking at people with advanced solid tumors and lymphoma or myeloma, and use genomic testing to assign patients to a treatment arm. And I think they had 1,200 people across 38 arms, and 60% had other cancers, like other than colon, rectal, breast cancer, non-small cell, and prostate, which means we got a broader set of rare cancers that don't often get seen in trials. And another good example is the lung map, it's an umbrella master protocol for non-small cell lung cancer, where the tumors from patients are screened broadly for the biomarkers, and then patients can then be assigned to different subarms for those specific biomarker therapies. So it is great to broadly increase the participation. However, there is a caveat and a caution. Master protocols only help patients who make it to the trial in the door.

Deborah Borfitz 17:29

My next question was that. Yeah. What kind of representation were it? Was it is there of of underserved communities in in those kind of trials?

Eugene Manley, Jr. 17:37

So if they aren't aware of the trials, aren't invited to the trials, aren't made aware of the pros and cons, and they have experience so much bias in healthcare, then it's hard to really move the needle as effectively as it could be. But these are are definitely a big improvement over what we have had in the past.

Deborah Borfitz 17:55

Yeah. Okay, good, good, good points. All of

Decentralized Trials And Patient Navigators

Deborah Borfitz 17:58

it. I want to also ask about because you know we hear a lot about decentralized clinical trials these days, it seemed like there might be a role for decentralized kind of clinical trials beyond even the diagnostic testing aspect for identifying potential trial participants. So, what sort of close-to-home features have you found aid recruitment and retention efforts in ways that that foster health equity in cancer trials? Did does anything work? A little? Does it help?

Eugene Manley, Jr. 18:24

I think we saw, even though for all the chaos that COVID caused, it allowed groups to show that you could do some things decentralized, which would make it easier for people that are traveling from far distances to get routine blood work done and some scans unlike quite make people travel up to an hour if they can do it in a local clinic. So I would say if you're close home, you could manage some of the fear, you know, the treatment toxicity. So you if you're home, you can already go home. Transportation is a big issue, you know. Then if you don't have to go so far away for your treatment, you might still be able to work. And then you're thinking about, you know, if you're caregiver, are you your sole caregiver, or do you have people helping you caregive so that these all factor into what you really can and can't do? So none of this part is flashy about the trials. This is what people really deal with. And I think using local labs and imaging can be helpful, but they have to be sort of built in the protocol from the beginning and at the start, you can't say we're gonna add this site in out. Like they have to really be integrated and make sure that the procedures are done the same so that all the data is good, so there's no questions about what's real, what's not real. And I think to a degree, virtual visits can be helpful if you're just doing rant, you know, check-ins, toxicity monitoring, and this also can tie into wearables because this stuff can be read in real time. So, but I think most importantly, which is the hardest thing, is that a patient navigator who can really walk the patient through why the testing works, why the biomarkers work, help with consent. So you I think the big key is you need those core, those navigators in the community. I think that's the best spot for them.

Deborah Borfitz 20:13

Yeah, wow, that that's there's a lot of lot of pieces and parts, but that that's it takes a village, right? In in in many sense here.

Precision Medicine’s Light And Darkness

Deborah Borfitz 20:22

This is ultimately about the state of precision medicine, since inequitable access to advanced diagnostics and lack of diversity and genomic research databases, the high cost of tailored therapies, mean that medical advancements can widen rather than close existing healthcare disparities, disparities. And I'd like to end today's show with your final thoughts on the sort of the best and worst points of alignment between precision medicine and equity goals and clinical trials. Where do you see the light as well as the darkness where our time and resources most need to be directed?

Eugene Manley, Jr. 20:57

I think there's definitely some rays of light. I think precision medicine really gives us the ability to move beyond treating cancer only by where it starts in the body and towards understanding what's driving it. That can mean better treatment selection, fewer ineffective treatment, more targeted therapies, more clinical trial matching. You can even think about where we're starting to use more multiplex imaging, though it's still not all clinically validated, but it's a way to stain your tissue multiple times with up to four antibodies per cycle. So if you can do 20 cycles, you can get 80 proteins on a tissue. So that could really accelerate what we get out of a tissue, which gets around the issue of you know, the lack of tissue that we have when we do biopsies. But I think the darkness is real, you know, because precision medicine is still wide disparities if only some patients get the access to biomarker testing, only some are treated with at major medical centers with infrastructure, only some can afford the time to get off work and travel to do the required studies. And only, as we know, the genomic databases TCGA and GWAS still are primarily based on European data, which means they aren't even reflective often of US populations and other populations that have disease risk. And so by not having these populations in the data set, that's where precision medicine can be a challenge. And as far as the last part about equity, you know, you when you think about equity, it's who is missed, who is being harmed, who is not getting access. And then precision medicine says what's biologically different about this tumor, this person, or this response. So when you get them working together, we can actually optimally make a much more equitable system where more people get treated and we can get better survivorship.

The Core Call To Action

Deborah Borfitz 23:02

Okay. So if you had to sum up your specific call to action, you would like to people to walk away with today if they remember nothing else from this conversation. What would it be?

Eugene Manley, Jr. 23:13

It would be, you know, everyone should get precision, you know, biomarker testing. Everyone should be able to participate in trials, and that you have to think about who is not present in the studies when you obtain the data before you run around and say, this is a great solution.

Deborah Borfitz 23:33

Okay, very good. May these words trigger the change that can help level the play field just a bit and maybe take precision medicine closer to its potential, you know, where the right treatments get to the right people at the right time. Thank you, Dr. Manley, for making us think about what it's going to take to get us there. And it's a lot.

Eugene Manley, Jr. 23:56

Thank you so much, Deb. It was a pleasure.

Deborah Borfitz 23:59

You as well will be talking in, Dr. Manley. And as always, a big thank you to everyone out there for listening in. If you're not subscribed to this podcast yet, please consider going to Apple Podcasts and doing so right now so you don't miss your monthly dose of news and perspectives. You'll be hard pressed to find anywhere else. And if you're up for it, I'd also be so very grateful if you'd leave a rating and review while you're there. For more straight talk on studies involving humans, visit clinical research newsonline.com. And if you're a clinical research professional, we hope also to see you at our next Scope Conference where we make things happen. Bye for now.