Rick Bangs, MBA, PMP, is the bladder cancer advocate on the genitourinary committee of SWOG Cancer Research Network (originally known as South West Oncology Group). He serves as chair of the SWOG patient advocate committee and is on the SWOG executive advisory committee.
Prostatepedia spoke with him about clinical trials for prostate cancer.
How did you get involved with patient advocacy in the first place?
Rick: When I was first diagnosed with bladder cancer, I sat outside the clinic, filling out forms for some clinical studies on quality of life, and I came to the decision that, regardless, some good was going to come out of my cancer.
I found out that I had prostate cancer after my surgery for Stage II (muscle-invasive) bladder cancer because, if you’re a man, when they remove your bladder, they also remove your prostate.
Three years after my surgery, I went to an advocacy event held by the Bladder Cancer Advocacy Network (BCAN). At the time, they met in two major cities a year, and Cleveland happened to be one of the cities that year, which was a four-hour drive for me. I went and met the president and co-founder of BCAN. I gave her a copy of the presentation I was giving the next day at the University of Michigan bladder cancer support group. We chatted and I offered her any help.
About six weeks later, she asked me to respond to an interview by ABC News about the disparities in cancer funding. That went pretty well, so she reached out to me about a month later and asked if I would replace her as the SWOG bladder cancer patient advocate. She said she couldn’t do everything that was being asked of her. I accepted, and that created a series of dominoes that led us to where we are.
What is it about patient advocacy that keeps you interested? What is it that keeps you coming back?
Rick: Being in the room where it happens, where change happens, and having the opportunity to work with really cool people on really cool projects to make a difference is what keeps me coming back. I enjoy doing that both directly in the spaces that I work in, which tend to be bladder and prostate cancer for obvious reasons, but also with my counterparts in the leadership roles that I have.
In bladder cancer, we’ve been on what some bladder cancer researchers once described as a “shallow plateau” for nearly a generation from a treatment point of view. That’s been changing in the last few years, but it’s been true for so long. For me, it’s raising that shallow plateau and being part of the process.
Would you say that what it means to be a patient advocate is changing?
Rick: Yes, particularly in research advocacy, a subset of this big, broad basket of things that patient advocates do. It’s amazing to see how our work is maturing.
There are things that I can do today to articulate with some specificity the work that a patient advocate does in cancer clinical trials. I can say: here’s the lifecycle, here’s what I can do at this stage, here’s what I can do at this next stage, here’s where you should involve me, and here are some other things that wrap around that from an organizational point of view. I can articulate those.
I can point to processes and expectations that didn’t exist two years ago and consensus around them. I can point to training across the five stages of the clinical trial – training on how to optimize the engagement of patient advocates and maximize the value that we bring to the party. I’m not talking about training just for patient advocates, but for patient advocates, principal investigators, leadership, and other members of a study team. That was a huge hole that we chose to fill at SWOG.
We did an environmental scan and found absolutely nothing; there was no training on engaging advocates in creating and running clinical trials. We had training for patient advocates on what cancer is, what trials are, and how to review a study concept. But we didn’t have any training for teams on how to more broadly engage patient advocates in the specifics of the activities that they work on.
What does SWOG do, and what is SWOG’s mission?
Rick: SWOG is this amazing team of exceptionally talented people who work in one of six networks in the U.S. and Canada that make up the National Cancer Institute’s National Clinical Trials Network, or NCTN. The NCTN was created by the NCI in the 1950s to test chemotherapies, which were new at the time, and it is the oldest and largest cancer clinical trials network in the country.
The whole reason that SWOG and the NCTN exists is to design, deliver, and share the results of clinical trials that will change the standard of care for patients, their families, caregivers, and partners. They’re funded by the NCI, which also provides critical support and services to the NCTN, like a Central Institutional Review Board.
That’s the general answer about SWOG and what they do, but it’s important to think about the results that SWOG has achieved. Since it was founded in 1956, SWOG research has led to the approval of 14 cancer drugs. We have also changed the standard of care over 100 times.
One of our biostatisticians did an analysis—and it’s a very conservative analysis—of how many years of human life we have saved. If somebody before a trial lived for 10 months, and now they live for 12, and if you multiply those two months times the number of people who have the disease, times the number of years since we changed the standard of care, the answer is: 3 million years of human life. That’s at least how much time we’ve saved for patients to be with their families and do things that are important to them.
When you think about the opportunity to work on things that are that important, it’s incredibly rewarding.
What kinds of trials does SWOG run?
Rick: We’re typically playing in the Phase II and Phase III space, although we also do some work in the very early Phase I (first in human) space.
We focus on trials that are going to change people’s lives in a significant way. That includes treatments and therapies but also prevention and survivorship. We don’t shy away from those topics in our scope of the work. We do research that the pharmaceutical industry itself will not do.
We work, for example, on dose reductions. You can imagine that a company has little incentive to get patients to take less of the drug they produce.
We work on alternate sequencing; this treatment, followed by this treatment, followed by this. We might look at how we ended up with a particular sequence and whether there is a better way to do the sequence.
We work on drug combinations. Individual pharmaceutical companies may have combination drugs, and they may have partners, but we look at combinations more broadly and create some synergy between drug combinations that pharma would not have considered.
We typically take on the complex and difficult. SWOG has more than 1,000 member institutions, and some are larger academic institutions, but we also have many hospitals and clinics in rural and suburban communities. The group that works to address the rural setting also makes sure we’re accounting for and addressing disparities in healthcare. We also do some work with cheaper effective drugs that may not currently get attention or investment from pharmaceutical firms.
In the bladder cancer space, we have a shortage of an immunotherapy drug that we’ve been using since the late 1980s. We were on the cutting edge back then, which for bladder cancer is like an oxymoron. We began to use Bacillus Calmette-Guerin, which is related to tuberculosis, and through testing in the late 1980s at SWOG, it was confirmed to be effective for many patients. It’s instilled in the bladder through a catheter. It’s a biologic, so there are different strains of BCG, it’s not a single drug, and it is difficult to manufacture. We have been using it for years, but now we’re down to one strain in the United States that Merck makes, and they can’t keep up with demand globally. We’re experiencing our third shortage in seven years.
SWOG is doing a study because, believe it or not, we really don’t understand how this 30-year-old treatment works, and we knew that there had been and would likely continue to be shortages, so we wanted to take care of both. We wanted to be in a position where we could address the shortages, but we also knew that there was potential to understand the mechanism of action of BCG and also potentially get better results with sequencing.
Research underlying the SWOG S1602 PRIME trial indicates, for example, that if people had a specific tuberculosis vaccination, and you waited a certain amount of time before BCG was installed in the bladder, that they got a better response than with just the installation in the bladder alone. This is because the immune system was primed through the vaccination and built up some immunity before installing BCG in the bladder.
We’re doing a trial testing a new strain of BCG with and without vaccination. I can’t imagine pharma funding a trial like this. It’s a low-profit margin drug, and people have walked away from it.
Yes, it could only come from an organization like SWOG. Pharma wouldn’t necessarily invest in, right?
Rick: Right, because they’re going after the hot, profitable immunotherapies. They’re not after this 30-year-old, low-profit treatment. That’s not where they’ll recoup their investment.
SWOG plays an important societal role!
Rick: Yes. As Americans, we don’t appreciate the return on the investment that we get from the NCI and these clinical trials. NCI pays for itself many times over. Most Americans don’t even know that the research is happening, let alone that it’s that beneficial.
Right, well, this kind of information rarely makes it to mainstream news, unless a sensational clinical trial either fails or is wildly successful.
Let’s say patients reading this understand the role that SWOG and other NCTN clinical trials play in the development of new drugs for prostate cancer. But why should they consider joining a trial? What’s in it for the individual man?
Rick: There are several reasons. First, anybody who’s diagnosed with any cancer will find that they, too, are on a shallow plateau in terms of treatment options no matter what their diagnosis, though exactly how shallow varies by the cancer. The treatments are insufficient, have unpleasant side effects, and never work fast enough. If we want to advance the science, and if we’re going to change these insufficient treatments, we’ve got to have clinical trials.
Second, no single clinical trial for a treatment ever studies a single question; we’re always doing other studies at the same time within the clinical trial. It’s like three, four or more studies for the price of one. We do the trial on the treatment, but we also learn the mechanism of how it and the cancer work, and we build up the knowledge that we need for the next set of trials. It pays off not just in terms of one clinical trial but a series of them.
Third, there are studies that demonstrate that the care that a patient gets in a clinical trial is great. Physicians who put patients on trials are very attentive and careful in their execution, going above and beyond the standard.
Fourth, giving back is another great reason for patients to join.
Last, but certainly not least, you are often given an opportunity to participate in a treatment or an intervention that may improve your cancer journey. That isn’t always the case, and there’s never a guarantee, which is why we do a clinical trial, but we know that clinical trials work about half the time. Some people clearly benefit from participating.
If a man understands that a clinical trial may be of benefit both to him and to society, should he start looking for a trial when his cancer has advanced beyond a certain level, or should he start looking for one when he’s first diagnosed?
Rick: I would suggest that a man check on a clinical trial no matter what his diagnosis, and, frankly, no matter what his disease.
There are clinical trials out there that span the entire lifecycle of every disease. People are doing work on prevention, early-stage disease, and late-stage disease. People are also doing work on caregiving. Partners, spouses, family, and friends are tightly integrated into the cancer journey, and there’s a place for them in clinical trials too. I would suggest that people ask about clinical trials no matter their diagnosis.
How would you suggest they go about finding a trial? Should they talk to their doctor, search online, or contact patient advocacy groups?
Rick: It’s always appropriate to start with a physician. The challenge is going to be the geographic dispersion of clinical trials. We know that most of them are centered in larger academic institutions and larger cities.
At SWOG and our counterparts, we have a community base that supports us, that ensures we’re getting out there. But for many patients, their physician may not know about a clinical trial.
Where should you go from there? You can search ClinicalTrials.gov, which I’ve worked on. You can search Cancer.gov, which includes only trials that are funded by or conducted at NCI sites. You can start with those and make a list, and then you can talk to the physician about narrowing that list down. Advocacy groups can be a great mechanism. Many of them are armed with people who are like me but even more focused on the specifics of the clinical trials and the disease settings. They can be very helpful. They know how to navigate online searches, but they also know how to work through the complex information about qualifying. If you’ve found a trial, you can use ClinicalTrials.gov to find the principal investigator, and you can ask them for further information and whether you qualify. Believe me, they are happy to help. Social networking is becoming a mechanism for people to connect, and particularly for folks with rare diseases or rare forms of common diseases. Facebook groups and web forums are good possibilities. Don’t be afraid to ask for help. If you talk to the physician and the physician says no, reach out to an advocacy group, or try to find something on ClinicalTrials.gov, or go out to a web forum or a Facebook page and ask about possibilities. NCI has a Contact Center that is based in Seattle. Don’t be shy about calling 1-800-4-CANCER.
What kinds of information do they provide at the call center? Can a patient, say, call up, explain their situation, and ask for a personalized list of trials available?
Rick: Yes! The NCI Contact Center helps connect a patient with a trial – but they never push a trial. These are neutral, well-trained counselors. They will go the extra mile. I don’t know what kind of success rate they have, but I know they get a large number of calls. But most people don’t even know to make the call. Contact Center staff also can chat online or answer questions by email.
Are there any considerations patients should keep in mind as they look through these trials?
Rick: The first thing to remember is that we do trials because we don’t have the answer. If you start searching for a trial, and you find something, you shouldn’t automatically assume that it is going to be successful. You have to come at it from the perspective that it may or may not benefit you personally.
Geography and institutions matter. If you ask your doctor, and the doctor says they don’t know of any clinical trials, that does not mean there aren’t any at other institutions or in other places. I would not take no as a definitive answer from a single physician, particularly in a more rural setting.
Oftentimes there are trials that require maybe an initial visit, or an initial series of visits, and then follow-up can be done remotely, correct?
Rick: Yes, though that tends to be a little tricky. It isn’t always possible. We keep trying to move in that direction. Patient advocates emphasize that as a possibility. It gets a little tricky because there are quality and recordkeeping considerations.
Convenience for the patient is certainly first and foremost, but typically specimen extractions can be complicated, even if it’s blood, urine, or tissue, and activity may need to happen around and to that sample and within a certain time. There are many complexities around that, but certainly that can be possible.
I’ve heard that it’s very difficult to find and recruit patients for trials, and that many trials don’t end up fully accruing. Is that true? Why do you think that is?
Rick: Historically, a number of trials have had to close because there weren’t enough patients. This is not current data, but some years back, about a quarter of trials had to close for insufficient recruitment.
We’re doing much better now, but why was that the case? Some trials were not as patient-centric as they might have been, and could have been better designed, asking more interesting, more potentially significant questions. Trials were mostly in large cities and access was an obstacle. We also haven’t always had exciting treatments to offer. We have more exciting things happening today. Immunotherapy is one example that’s more exciting today. So trials are much better today, though we still have challenges.
Why do we still have problems recruiting patients? First, patients are not always offered a clinical trial, in part because clinical trials are not everywhere. It’s not like I can just go to my primary care, emergency room, or my local clinic and say, “I’m here for the clinical trial.” That doesn’t happen.
There are logistical and access challenges. Patients are not always asked, and when they are, they are concerned about placebos. But we don’t do clinical trials where patients get nothing instead of something that works that they would normally receive. They’re going to get something, or they’re going to get the alternative. We’re not going to take anything away from you. That never happens, but people think it does.
There’s a misconception that clinical trials are only for people who are desperate for hope, when nothing else has succeeded. That is not the case. That keeps people from asking and participating. Trials are available across the cancer journey.
People generally have poor awareness of clinical trials, and many don’t understand how medicine works. But they should know that we have decided how and when to use every drug over many decades thanks to clinical trials. We don’t just say, “Here’s a drug that works in the lab. We know it works with a mouse, so here you go, patient.” We don’t do it that way.
Do you have any particular prostate cancer clinical trials you’d like to highlight?
Rick: I’m in the genitourinary committee, so I know a little about what’s going in the prostate portfolio. There’s a trial that we’re doing that nobody else would do. We’re asking if someone who is initially diagnosed with metastatic prostate cancer should receive treatment for their prostate. By metastatic, we mean the cancer is in the prostate and has spread beyond it.
We have similar questions in some of the other cancers. The general school of thought is that unless you respond to treatment, whether it’s chemotherapy or radiation in this particular context, we’re going to give you chemotherapy or radiation, but we’re not going to give you any other treatment to either surgically remove or radiate your prostate. That’s the standard, but there’s no good data underlying that.
We’re doing a randomized trial, so the computer decides which treatment you get. One group of metastatic patients will get some kind of systemic therapy, whether it’s chemotherapy, radiation, or another treatment. The other group will have the surgery or the radiation in addition to the systemic treatment.
How big is the metastatic trial?
Rick: It’s a large Phase III trial with more than 800 patients.
[You can review this trial here.]
This trial demonstrates SWOG’s willingness to research these interesting, needy kinds of questions that nobody else would take on.
SWOG has other counterparts, so this is not just a characteristic of SWOG. This is what the NCI-funded NCTN network groups do.
Is there anything else that patients should know about clinical trials?
Rick: Patients should ask. That’s the big thing patients should do: ask questions, and ask for clinical trials. If there is a clinical trial that you think you qualify for, you should consider it, and ask questions about it. You don’t have to participate, but ask and consider. You owe it to yourself to do that. And if not, you owe it to those who follow you. It’s meaningful work. It may help you, but you shouldn’t just do it because you think it’s going to help you—we don’t know if it will. There is no guarantee, but: ask and consider.
About Rick Bangs, MBA, PMP
Rick Bangs, MBA, PMP, is the bladder cancer advocate on the genitourinary committee of SWOG Cancer Research Network (originally known as South West Oncology Group). He serves as chair of the SWOG patient advocate committee and is on the SWOG executive advisory committee. He lives in Rochester Hills, Michigan. Rick has 25 years of experience in information technology and marketing, and is advising on the redesign of ClinicalTrials.gov. He is co-chair of the NCI Patient Advocate Steering Committee, and serves on the NCI GU Steering Committee and the NCI bladder cancer Special Programs of Research Excellence (SPORE), and actively supports the Bladder Cancer Advocacy Network and Movember. He is a bladder and prostate cancer survivo