publication date: Nov. 20, 2020

Conversation with The Cancer Letter

ASCO’s new CMO Julie R. Gralow will focus on equity, advocacy, and global health

Julie-Gralow-2

Julie R. Gralow, MD, FACP, FASCO

Clinical director, breast medical oncology, Seattle Cancer Care Alliance;

Professor, medical oncology, University of Washington School of Medicine;

Professor, Clinical Research Division, Fred Hutchinson Cancer Research Center;

Executive officer, breast and lung committees, SWOG Cancer Research Network

 

Julie R. Gralow, an expert in breast cancer, clinical trials and global health, was named chief medical officer of the American Society of Clinical Oncology.

She succeeds Richard L. Schilsky, ASCO’s first CMO, who took the job in 2013 and will retire next February.

“When Rich came on, there was really no hard-and-fast rules around the job description. What’s great about ASCO, I think, is its fluidity and its constantly looking at what’s working and what’s not,” Gralow said to The Cancer Letter. “What I’m looking to add to it is, I think, part of the equity piece. I bring a lot of the patient advocacy perspective to it, and I will be working on the global piece.”

Gralow is a professor of medical oncology and director of breast medical oncology at the University of Washington, Fred Hutchison Cancer Research Center, and the Seattle Cancer Care Alliance. She is also the SWOG Cancer Research Network’s executive officer for the breast and lung committees.

Gralow will begin her new position on Feb. 15, 2021.

“Julie has all the qualities we were looking for in ASCO’s new CMO,” ASCO President Lori J. Pierce said in a statement. “She has a vision for the future of oncology backed up by a significant record of accomplishments in clinical cancer care and research. She knows how to lead large, multi-disciplinary teams. And she is a thoughtful and compassionate person. I know she will provide wise counsel as we work together to advance ASCO’s mission.”

The CMO position provides medical and scientific leadership for ASCO’s research, public policy initiatives, and communications, and global programs—as well as fundraising for ASCO’s affiliated foundation, Conquer Cancer. The CMO is a member of the executive leadership team and reports to the CEO.

“This is a pivotal time for ASCO and in the broader field of oncology,” ASCO’s CEO Clifford A. Hudis said in a statement. “The pace of scientific progress has never been greater, but COVID-19 has brought challenges to virtually every aspect of cancer research and care. I look forward to having Julie on our leadership team as we navigate these unprecedented times while remaining focused on improving the care of patients during the pandemic and beyond.”

 

Gralow spoke with Paul Goldberg, editor and publisher of The Cancer Letter.

 

Paul Goldberg:

First of all, congratulations. This is one of the most interesting jobs in the field.

Julie R. Gralow:

I think it is, too. So, thank you very much. It’s a terrific job, and I’m stepping into some big shoes.

 

PG:

One part of the job is to educate and explain, but there’s also a component of moral authority. Isn’t there?

JRG:

I’m trying to process that. I think that my job will be to help serve our members so that they can better serve their patients, but that we’ve got to be broad. With respect to the moral authority, I don’t think we’re coming down from a top-down standpoint saying, “This is what’s right,” and all of that, but we are just trying to help make everybody do better. Do better for our patients. That’s the goal in the long run.

I’m not sure if you meant something else by that.

 

PG:

Well, right now, delineating the truth from untruth, in this political environment, turns into more than just an education or an imparting of information. It’s more like right and wrong.

JRG:

I think ASCO has always been evidence-based, the source we go to, where we can trust it. I’ve always pointed my patients to Cancer.Net, for example, once Cancer.Net got started, saying, “There’s lots of stuff out there on the internet, but I can tell you that Cancer.Net has been reviewed, it’s evidence-based, it’s science.”

There are things we don’t know for sure, because we haven’t done the study, but you can trust that. I think the same is true for our members. They go to ASCO for the guidelines, for the recommendations, for the big annual meeting, where we present the scientific evidence, and ASCO is always in those oral sessions, and, increasingly, in poster sessions, with an independent discussant as well, which has always been an important piece.

You’ve got people up there on the platform, they can essentially say what they want about the research results, but you know it’s going to be discussed by somebody who is going to reign them in, hold them accountable if they are overstating things.

All of this means that our members and attendees can trust us not just to deliver the content, but to put it in context.

 

PG:

How does this moment in history shape what you intend to do? And I’m talking about gender equality, racial justice, disparities.

JRG:

There’s a lot going on, isn’t there?

 

PG:

It will be an interesting job.

JRG:

Yeah. This is an exciting time with respect to equity and justice, because I think we’re gaining a foothold, and it’s going to be hard to go backwards.

For years and years, wearing my global hat, I’ve looked at this as equity across the globe. Why should your ZIP code determine whether you are going to live or die from cancer or whether you are going to get this treatment or not? That’s a quote from Princess Dina Mired, who is the current president of the UICC.

ZIP code shouldn’t determine whether you get treated for cancer, much less whether you live or die. So, from a global scale, I’ve been interested in that my whole career and, increasingly, I see the movement taking afoot that yes, inequities exist across the world, but they absolutely exist within our own country.

And maybe we can use some of the same tools for leveling the playing field and getting access to care and overcoming barriers to care right in our own backyard. So, we’ve got, as you say, the racial injustice and disparities piece that I really think the time is right to make some big changes.

We’ve got COVID-19. Hopefully, someday we’ll have the recovery from the pandemic. We’ve learned a lot; haven’t we?

 

PG:

Let’s get to COVID in a moment. I want to stay on gender equality issues. There are many highly qualified women in this field, so gender equality should be an easy problem to fix, if there is determination.

JRG:

Well, there are a lot of subtleties to it.

While we’ve got plenty of women, both community physicians and academics, in oncology, practicing oncology, it’s at the leadership level where we still have some of those gender gaps. And when we look across medicine in general, the percentage of women going to medical school now is at least equal if not, in some medical schools, even slightly higher than the ratio of men.

But those who rise through the ranks, at least in academics, and get promoted to full professor in the end, etc., drop out for a lot of reasons. And some of them are fine reasons, but we’ve got to get rid of the ones that aren’t.

Hanoi-Hospital

Visiting medical students at a hospital in Thai Nguyen, north of Hanoi in December 1999.

 

PG:

I’m hearing it said that this is a problem that can be solved tomorrow. I mean, just fix it.

JRG:

It’s very refreshing. There is a biotech in my region that you undoubtedly know about. And they made a commitment to have their board be at least 50% female, and to have their workforce be at least 50% female.

And from the beginning, they created a Women in Science lectureship that I was invited to speak at in the very early days, as one of the first speakers.

And they asked me to just tell my story, and how did I get here and who were my mentors, etc. And what was fascinating about it was that the audience was almost half men that came to this Women in Science lecture.

It was a real culture, because at the top they had committed to this. So, we can do things like that.

 

PG:

It’s wonderful that it’s happening. Can we talk about COVID for a moment? What’s ASCO’s role in COVID, and what is ASCO CMO’s role, most importantly, in dealing with the pandemic?

JRG:

Early on, ASCO served as a resource for latest updates and best practices. When things were changing so fast and nobody knew what was going on, and we didn’t understand what we could do with telemedicine. We didn’t understand what the best restrictions were. Should we be shutting down the ORs or infusion rooms?

So, ASCO  created a hub. And then, because they had the CENTRA research infrastructure, they also were able to create a COVID registry that I think we are going to continue to do research from and learn from for years to come.

But as I see it, we’ve all in various ways figured out how to protect our patients.

What do you really need to come in for? I mean, as a clinical trialist, we really thought how we do clinical trials. Can we do consent by telemedicine? Do we really need to bring our patients in to come from a distance just to get vitals, or could they do that locally? And it wouldn’t be a protocol deviation.

What are the things within clinical trials that we can ease up that will be sustainable in the long term and make it easier for patients to be on a trial, easier for us to accrue to a trial?

The telemedicine and the cross-state licensure is really complicated and it changes, it seems to me, almost weekly.

I sit here in Seattle. We’re the only academic medical center for a five-state region: Washington, Wyoming, Alaska, Montana, and Idaho. I have patients all over, across states, and it’s really tough to figure out on any given day what I need to do on a telemedicine visit in Montana versus Alaska versus Hawaii.

Montana decided that we could get pandemic provisional licenses if we had our own state license and filled out a form. I’m now licensed to also practice in the State of Montana during the pandemic. So, I can see my return patients. Otherwise, I’d be practicing outside my scope across state lines.

I think ASCO is going to have to play a role in helping what happens post-pandemic with telemedicine, with clinical trials, and with all of the things that have changed in our practice.

And I think ASCO is a good resource to be able to share what the practices are dealing with, and help our members in solving all of this and understanding what we can do, what we can’t do, and updating, if something isn’t making sense as the pandemic ends, something that was good that we think should continue.

But there are legal issues, and things that get in the way. ASCO can help advocate for that on a broader basis than any individual practice or state could.

 

PG:

So, that would be a part of your role as a CMO?

JRG:

Yes.

 

PG:

Are you worried about becoming a leader at ASCO when it looks like work will be virtual for another year, and it’s really not clear that there will be another face-to-face ASCO annual meeting?

JRG:

For a while anyway. Am I worried about that? No. I mean, progress is being made in cancer.

Clinical trials are ongoing. For example, from my past as a breast clinician, I am excited that we’ve had five or six new drugs approved in the last 18 months.

And this is on pace to continue, as more practice-changing studies come to fruition. I’m looking at the agenda for the San Antonio Breast Cancer Symposium coming up in a few weeks. There’s some really important practice-changing data that’s going on there.

While we all miss the face-to-face, I think ASCO did a really good job of pulling together, at short notice, a virtual meeting that worked for the most part, that resulted in more “attendees” than ever.

What I’m hearing, with my global hat again, from all of my colleagues—especially those in low- and middle-resource countries and in some other countries, where only the very top leaders get permission to leave the country to come to a meeting like ASCO—I’m hearing about all kinds of people who were able to participate in the ASCO annual meeting this past year, who never would have been able to.

While I think there’s no question that we will go face-to-face again when it is safe, I think there’s going to be some component that helps with that virtual piece that engages all those people who were able to participate this past year, and really appreciated it and were excited about it and would not be able to participate in a regular year. We’ll learn from that as well.

 

PG:

Why did you move from a conventional academic career to ASCO? What would you be giving up, what would you be gaining, and what can you accomplish at ASCO that you might not be able to accomplish in a conventional academic setting?

JRG:

I’ll be giving up my day-to-day patient practice. There’s no way to safely treat a group of metastatic breast cancer patients where, at least post-pandemic, I’ll be in Alexandria a good portion of the time.

I’ll be giving up that day-to-day direct patient care, but I have a very strong connection built over the past almost three decades with the patient advocacy community. I don’t expect that my interactions and relationships with the patients, who are always driving us to remember what our focus is, that I will lose that patient connection in that way.

I will lose it in terms of being their primary provider. In my SWOG executive officer role, I am very involved in the startup of a lot of clinical trials at a high level, the training of our young up-and-coming clinical trialists.

In moving over to the ASCO CMO role, I won’t be as directly one-on-one involved in the young investigator training or the fellows, but I’ll be able to much more broadly impact their opportunities, their networking, what happens as they move from fellowship into early career, into mid-career. I’ll be able to really help at a higher level.

I won’t be the PI on another trial, except for, ultimately, overseeing at a high level the TAPUR trial and perhaps those yet to come at ASCO. But with the goal being that there will be lots of other people who get the academic credit for that, and I serve as the facilitator for that, really.

I think I can create a lot of opportunities outside of Seattle, at the national level in serving our members, but also what I’m really very excited about is taking it to the global level.

In ASCO’s five-year strategic plan, one of the four major goals is to make a global impact. We just published our ASCO Academic Global Oncology Task Force set of recommendations, which were presented to the board, and were approved by the board.

I’m super-excited about taking that and implementing it.

 

PG:

Let’s get to that in a moment. Can we talk more about the role of the CMO? Because, well, Rich was the first CMO ASCO had. He defined the job as it currently stands. You will be redefining this job. What are your plans? What will you do that’s not being done? How will you do it differently from Rich, if you’re going to do it differently? What do you intend to pursue at ASCO?

JRG:

You’re correct that when Rich came on, there was really no hard-and-fast rules around the job description. What’s great about ASCO, I think, is its fluidity and its constantly looking at what’s working and what’s not. It’s very strategic with the board. Also, I think Cliff is a great CEO. Like anyone starting a new and complex role, I am sure I don’t know everything about the role—yet. I will know more in a few months.

What I’m looking to add to it is, I think, part of the equity piece. I bring a lot of the patient advocacy perspective to it, and  I will be working on the global piece. In addition to what Rich has set up—the research piece with CENTRA, which is an amazing clinical trials network—I agree with ASCO’s board that we should not be competing with the National Cancer Institute, the cooperative groups in any way. That has not and will not be ASCO’s role.

But as I view the work of CENTRA, it’s clearly a service in a way to our members. I look at the TAPUR trial and all of the genomics and the matching of drugs and ASCO’s ability to bring a bunch of industry together to have access to their drugs with the right genomic alteration.

In my clinical practice today, for a lot of those I’d have to either enroll in the MATCH trial, which is very complicated and usually it doesn’t have an arm that matches, or do single-patient INDs, which my clinical trials group has the money and the resources to do, but a community oncologist group, unless they’re quite large, doesn’t.

This is, in a way, getting access to genomics and drugs, and then collecting it in a way that will be publishable, where we will be gaining evidence, where we can get it into our guidelines, and all so that then we can have it covered under whatever insurance scheme the patient has, because we’ve provided the evidence.

I think the research piece will go on, as I talked about the COVID registry. There are several COVID registries out there and they all have their own unique features. ASCO’s is very valuable because there’s going to be a very long-term follow up of these patients in this registry plus insights into the practices themselves.

The equity piece, the patient advocacy piece, the global piece, the post-COVID piece. I think those will all be things that I’ll be adding on top of what Rich has created.

 

PG:

Let’s back up a little bit to Big Data. What about CancerLinQ, for example? How should that be done, or is it going to be changed?

JRG:

CancerLinQ is really a valuable resource, both for the practices that participate in it, as well as the researchers, and at all levels to get data back out to share with its users and others.

The whole idea of seeing what you’re doing, what your outcomes are, how compliant are you with pathways, how do your outcomes compare, I think it’s really important. It helps us do our best work, right?

It helps us with the best quality if we see what we’re doing and we compare ourselves to others. I think CancerLinQ is serving that important role in an increasing way and I am excited by what is ahead.

 

PG:

So, it remains unchanged. What do you see as the greatest opportunities for ASCO in the years ahead?

JRG:

We’ve got a strategic plan to 2023. We need to meet the needs of our members, number one, so they can best meet the needs of our patients.

That starts with how we help them  optimize quality of care. CancerLinQ falls in there. It also includes how we steward our resources and help them do the same. Oncology care is very expensive, and financial toxicity to our patients is real. And it also extends to our desire to have a global impact.

Thinking about quality and cost, we’ve got to tackle that.

As I said, in breast cancer we’ve had five or six new drugs approved in the last 18 months and they’re all exorbitantly expensive. We’ve got to best figure out how to practice quality care, but also care that doesn’t bankrupt our patients and our country.

Globally, I see a real opportunity for collaboration across other societies outside of ASCO, with ESMO for sure and the European societies. AORTIC, the African Organization for Research and Training in Cancer, and the Asian societies.

We’ve been doing some of that, but I think partnering more globally, we are going to come together, we’re going to collaborate, and we’re going to be better partners and collaborators.

Just this week, WHO announced their global campaign to eliminate cervical cancer.

I would view, with my ASCO CMO hat on, we should be at the table on that, because even though cervical cancer mortality is currently not high in the US because we do screening, we certainly still have populations that have very high rates. We don’t have good uptake of HPV vaccines for a variety of reasons.

We should look at innovative ways for screening. I’m very excited about doing studies and getting approval for an HPV self-swab. Now we have new guidelines that if you’re HPV negative, you only need to come in every five years. And you would only do a pelvic examine and cytology, a Pap smear.

If the HPV was positive, we have the potential, if it works, to do HPV self-swabs, so women don’t even need a pelvic exam. And that really removes a lot of barriers, especially in some of our racial, ethnic minority groups. You ask, what the vision would be. I would view that we can partner better with our global community in, for example, this eliminate cervical cancer campaign.

I hear back from patients that ASCO seems to be a lot about treatment, but not as much about the prevention. I think we need to be more visible in the prevention piece as well.

We can partner with all the efforts going on at the UN level and the WHO level in healthier lifestyles, and smoking cessation, and all of those things that are part of the UN’s current NCD strategic plan. And we’re not promoting that as much in the U.S.

So, I think that’s another opportunity.

 

PG:

Especially now. It’s a new day. Can we talk about international oncology? For you, this has been a career-long interest. Can we talk more about how it began, how you see it, how your interest has evolved, and how that would affect ASCO?

JRG:

Well, it wasn’t on my radar even when I came in fellowship and I arrived in Seattle. And then, in about 1997, I was approached by a Seattle-based NGO, PATH, that used to be called the Program for Appropriate Technology in Health. Now it’s just PATH, kind of like SWOG. It used to be Southwest Oncology Group, but now it’s just SWOG.

PATH, which had expertise and structure in many countries, mostly related to infectious disease. So, post-Chernobyl, USAID, with the U.S. Congress providing money, wanted to do something in Ukraine. And they looked and saw that post-Chernobyl exposure, we expected that certain cancers might increase years later, like breast cancer, as we saw post-Hiroshima, for the young women exposed.

And so, Congress voted. USAID put out an RFA for a Ukraine breast cancer assistance project in conjunction with Ukrainian ministry of health. PATH won the contract, because they had infrastructure already set up through Ukraine, through Eastern Europe for infectious diseases, for vaccines, essentially.

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Kyiv, Ukraine – March for Life and Hope, 2003, with breast cancer support group Amazonki.

 

They were trying to get together a group of breast cancer experts, and they thought we’ll just select a group from Seattle, so we don’t have to pay a lot of extra expenses of flying people around and all. I was pretty young in my career. I was junior faculty, but they said, “Would you like to do a three-year consultancy on this Ukraine breast cancer project?” And I said, “Sure, that sounds interesting.”

And we did it.

I helped collaborate and run a clinical trial in Odessa, in conjunction with the chemotherapist there. That served a couple purposes. One was to help teach them how to do clinical trials. The other was, it was a preoperative chemo trial to show the surgeons that chemo actually worked.

So, we chose the preoperative setting so everybody could see the tumor shrink and show that chemo worked.

At the time in Ukraine, the surgeons ran the show. The chemotherapists were just kind of handed the patients after surgery and didn’t have the same status and respect. And so, that little clinical trial that we did in Odessa set them up so that they got a clinical trials infrastructure. They now, as do a lot of other sites in the country, participate in a lot of industry-sponsored trials.

We had a big national meeting. The surgeon saw the value of chemotherapy, the value of even discussing it preoperatively when the disease is locally advanced. And so, just through that little project, I said, “This is amazing how with proper respect and partnership and being safe, we can actually help change.”

They used results from the various projects that we did in that PATH project to rewrite what their pathways were essentially, and how they treated breast cancer.

And a big piece that came out of it was that there was another group—and I did not lead this—that was interested in creating dialogue between the healthcare professionals, the doctors, the nurses, and the patients.

The Soviet-era teaching was, you don’t tell a patient they have a fatal disease, because they’ll go and kill themselves before dying of the disease. So, don’t tell a patient they have cancer. They’re going to go commit suicide. And if you read Solzhenitsyn’s “Cancer Ward,” that’s the era, essentially.

These patients were sitting in a cancer hospital, on a chemotherapy ward, and yet they would say to their doctor or their nurse, “I have cancer; don’t I?” And they would be told, “No, you don’t. You have a very bad infection of your breast. So we had to remove it. And now you need very potent antibiotics that are going to make your hair fall out.”

It was done in a way where they thought they were protecting the patient. But, of course, everybody knew the patient had cancer. They were on a chemotherapy ward, labeled chemotherapy ward in a cancer hospital, labeled cancer hospital. And they didn’t have the opportunity to talk about it, or to be connected with others or to get information.

One of the projects was related to talking to some interested doctors and nurses who were willing to help start giving some education and having that dialogue and learning how to have that back and forth, and some patients who were interested in doing the same.

And by the end of that three-year period, there were actually breast cancer support groups popping up around Ukraine.

In 2001, the Amazonki, which were named after the mythologic Amazonian women who cut off one breast to better be able to use a bow and arrow, actually got permission to shut down the main street in Kyiv, the Khreshchatyk Street, to have a “march for life and hope,” with pink balloons and a marching band for the daughters, so that the daughters could learn about their cancer risk. And so that people could see survivors. “Yep, I had breast cancer and I’m alive.”

And back in that era, in 2001, to get a permit to do a march down the main street in a former Soviet country was a big, big, big deal.

So, that’s how I got involved. That was a very long answer, but that’s what started it.

And then I said, “Wow.”

It didn’t take much to really change, in a very good way, some things that were happening in Ukraine, and build relationships, and build dialogue that has persisted to this day.

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Gralow’s first trip to to Uganda Cancer Institute for teaching in 2009, before construction of a new outpatient/research building of the joint UCI-Fred Hutch cancer center.

 

PG:

And you’re doing this, of course, elsewhere around the globe. You’ve mentioned Africa.

JRG:

Well, the Fred Hutch has a relationship with the Uganda Cancer Institute that basically started with HIV-related cancers: Kaposi sarcoma, lymphomas, cervical cancer side to that as well.

It was really our infectious disease people. There was a lot of HIV money out there, not much cancer money. So, they got a big grant with HIV-related cancers and set up a true collaboration, a partnership with our Ugandan colleagues.

We started having some of the Ugandan oncologists come over to Seattle, some for short periods of time just to see what our clinics look like, and others to get a master’s or even get a PhD. They didn’t have a formal oncology fellowship training program in that era.

Several of them, when they came over, said breast and cervical cancer are the most common cancers in our women. We want to spend time in breast cancer.

That’s how I got to meet them and establish relationships and create some projects with them and got to know them. As the years evolved, we added breast and certain other cancers that were common there. I’m now on the steering committee for a formal adult hematology/oncology fellowship program that the East Africa Development Bank is paying for at the Uganda Cancer Institute.

I’ve watched what’s happened there. What happened in Eastern Europe, Central Asia was with these support groups starting.

I told them that I’d come back every once-in-a-while, and bring them together, give a talk. And that’s how my weekend project, the Women’s Empowerment Cancer Advocacy Network, got started. Every two years since 2003, we’ve facilitated getting together between 12 and 15, mostly former Soviet, but other Eastern Europe countries, bringing the patient advocates together.

Then I started meeting Ugandan patient advocates, and they said, “Can we do something in Africa like what you’re doing in Eastern Europe, Central Asia, to promote the patient advocacy movement?”

I said, “Well, I think it’s going to be a lot different, but let’s try it.”

In 2013, we hosted the first of our annual series of East Africa weekend meetings, in which we bring together, again about 12 to 15 countries, the leading patient advocates who have their own nonprofits.

We do some education—they want to make sure that they’re promoting evidence—but also a lot of networking and learning from each other, which is the best part of it all. We missed this year. It was supposed to be in Malawi, but COVID hit, and I’m not sure we’re going to be able to do one face to face, but we’ve got some ongoing. 

We’re working with the NCI’s Africa ECHO project, with a forum for having regular meetings. We’re working on a big women’s cancer survivorship effort in Africa right now with the NCI Center for Global Health at ECHO Africa, with key leaders in Africa.

And we are going to kind of translate the Breast Health Global Initiative survivorship guidelines and the NCCN harmonized guidelines for Africa into some survivorship guidelines specific for Africa, designed by Africans, agreed to by the African community, and then promote survivorship efforts within Sub-Saharan Africa. That’s a big project going on now even though we’re not able to meet face to face.

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Lagos, Nigeria – World Cancer Day activities, February 2016.

 

PG:

I’ve never understood why there are so few clinical trials being done through the cooperative groups, for example, internationally. It’s very rare. I get the bureaucratic explanations, which get me only so far.

JRG:

Well, it’s because of the rule. For the NCI to pay for a trial through the cooperative groups, it has to be open in the U.S., as well as the other countries.

A lot of the trials that we would propose aren’t exactly the leading questions in the U.S., or wouldn’t be standard of care. SWOG has a Latin America initiative, and we just spent last week having a virtual meeting in Santiago.

The first meeting was actually canceled at the last minute due to political unrest a year ago, and then it was rescheduled, and then postponed due to COVID. And now we just decided we’re going to do it virtually.

I spent last week virtually in Santiago with the SWOG Latin America network, but the problem is there are great researchers there, there are great questions, but for the U.S. government, the NCI, to pay for them, they have to be open, not just in the Latin America countries, but in our U.S. site. And a lot of them are really, really, really important questions, but they just are not the same questions and the same standard of care as we would have in the U.S.

So, we have to find external sources of funding if we’re doing a trial exclusively in our Latin America network. And we do have some examples of that.

Also, they can join on any of our other trials that the NCI is paying for, but there are complicated issues with even just getting them study drug. The shipping of drug across borders, of drugs being provided by a company. If we’ve got the U.S. side of a company giving us free drug, then we want to open it in Latin America, and it’s a totally different group of people to work with.

We try to do studies with China, for example, and they have prohibitions on shipping any biologic specimens out of the country. So, there are a lot of issues.

There’s another Seattle group called BIO Ventures for Global Health that works with industry. And they’ve created a couple of things.

One’s called the Africa Access Initiative, but more relevant to your question, they have something called AC3T Africa Consortium for Cancer Clinical Trials, and [they are] going in and finding sites in Africa that they fill out surveys.

They go in and inspect them, and they certify them as being a site that could do a clinical trial, and they’re creating a network so the industry can come in and have the assurance that BIO Ventures for Global Health knows these people. They’ve certified them. They have the ability to do blood draws, do the biopsy, and deliver the drug safely with supportive care meds.

There’s some people working on very good opportunities to do more of that, but with respect to the cooperative groups, which is what you asked about, we have big barriers in place from our own how we get our money from the government.

It says it comes with a statement that this has to be done in U.S. patients. And if you can figure out how to add on some others, that’s fine, but it’s got to be predominantly benefiting Americans, is kind of the current ties to that money.

 

PG:

I guess the industry has been able to figure out how to do this well enough. There are a lot of drugs being approved based on non-U.S. data, but can ASCO play a role in making it work better?

JRG:

I think in terms of the ease of doing clinical trials across multiple countries and multiple sites and all of that, ASCO can certainly use its voice in terms of some of the policy, some of the gravitas that comes along with being ASCO and collaborating.

I don’t know that we’re going to be able to turn around things as easily with respect to when money comes out of our own government, what NCI can do with it. I think there are certainly people in the NCI Center for Global Health who would like to ease that up a lot, too.

So, I think I need to learn more about that piece of it, and how ASCO can help with it, because we certainly have some barriers there.

 

PG:

Well, the president-elect really gets it.

JRG:

Well, and he is interested in cancer; right? So, we may have a new era coming.

 

PG:

Yeah. Is there anything we forgot to talk about? Anything we forgot to mention?

JRG:

I think we talked about a lot of things.

 

PG:

Thank you.

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