Understanding Clinical Trials

Does the thought of participating in a clinical trial as part of your cancer treatment bring you thoughts of hope or conjure the image of a guinea pig?

Dr. Dan Rubin speaks with one of our neighbors on campus, Dr. Frank Tsai from the Virginia G Piper Cancer Research Center to answer some common questions about clinical trials.

Availability, scheduling, timing, finding the right trial for you, and how to talk to your doctor about clinical trials; all this and more, on this edition of Ad Hoc with a Doc.

Rubin: Hi, I'm Dr. Dan Rubin, here with another episode of 'Ad-hoc with the Doc'. I have the pleasure of being with Dr. Frank Tsai, a medical oncologist, we're actually neighbors. We’re on the same campus here at HonorHealth.

Tsai: That’s right.

Rubin: I can't wait for you to be able to tell our audience what you do because it's really exciting. We're going to talk today about clinical trials: how to navigate it, some inside views from somebody who's really doing the work and in the trenches with the patients. What is a typical day or a typical week look like for you in terms of being in clinic or being in the research side of things.

Tsai: So, my typical day would begin in the clinic where I will see a number of patients who have come to me by way of either from their oncologist or they themselves are looking for a trial.

Rubin: Okay.

Tsai: And as I see these patients and determine their clinical eligibility, I help them to find the best possible kind of a trial for their disease.

Rubin: So, you are a doctor that other doctors refer to, to see if there's an appropriate clinical trial and or you said some people self-refer because they're interested in clinical trials.

Tsai: Uh-huh.

Rubin: Is that a normal thing, so to speak, where people are coming in? Or is that unique to your practice or Arizona? How does that work?

Tsai: Yeah, it's not really not unusual, Dan.

Rubin: Okay.

Tsai: Patients have self-referred by way of a number of different channels, either they perhaps heard something on the internet, saw something the headlines — immunotherapy came out; President Carter's cancer was put into remission by immunotherapy. They also have come by way of navigators such as American Cancer Society.

Rubin: Okay.

Tsai: So, patients are very interested in what other options they have.

What are Clinical Trials and How Have They Changed Over Time?

Rubin: Could you please explain for me and for the audience what a clinical trial is, and what's the difference between a clinical trial now and maybe say 15 years ago and how they were being run?

Tsai: Clinical trials are investigational treatments. What that means is that these are not FDA approved drugs. These studies are being done to determine a number of different factors, whether it’s the optimal dose, to whether they work —

Rubin: Safety? If they work, like you said…

Tsai: Exactly; or compared to the current standard treatments.

Rubin: Okay.

Tsai: Now, clinical trials have evolved tremendously in the last 15-20 years. There are different methodologies to streamline the process and help patients to get into trials easier and faster.

Am I Going To Be A ‘Guinea Pig’

Rubin: Patients, we’ll be in my office, we’ll be in consultation, and they'll mention that maybe they’re interested in a clinical trial—their friend or family members discussed it with them or brought it up, or maybe they've been referred to you by their medical oncologist; but when we're talking they have apprehension, or they're scared. They feel as if they're not sick enough for a clinical trial, because they've heard that these are for the last-ditch efforts, when there's no other treatments; and sometimes, you know, you've heard the word guinea pig, like ‘I feel like I might be a guinea pig’. My guess is you've discussed this with patients before.

Tsai: Yeah, you know, that's that's very observant. You're absolutely right, patients have tremendous fear, and the reality is we need to do a better job in informing patients of their treatment options. Clinical trials, the reality is, have some uncertainty, and trials can vary tremendously—from a brand new exciting drug with a new mechanism, or a trial about combinations of drugs that is already approved.

Rubin: Interesting, okay.

Tsai: So, I think it’s understandable that patients feel like it may be a guinea pig approach, but the reality is that there's many new innovative treatments to give patients.

How Can Clinical Trials Be Found?

Rubin: A lot of our lives are spent online, a lot of our resources are on there now—we're shopping for things, we're getting ideas, recipes, information—medical information; but it still seems difficult for somebody to go on the websites and look for clinical trials. And a lot of them seem confusing and the language that's used, for a patient to go in there and to figure out: if there's a clinical trial, which one, and when.

Tsai: I think that's a very accurate statement. Clinical trials are complex, and the current resources are really limited to clinicaltrials.gov, which is a federally required registry.

Rubin: Clinicaltrials.gov


Tsai: Clinicaltrials.gov. However, the limitation is that information is often behind on where the actual trial is at.

Rubin: It's not up to date, real time?

Tsai: It's not up to date, real time.

Rubin: So, patients going in there thinking that they're seeing what's hip, modern, and they're gonna look at this drug—but they may find, what?

Tsai: They may find that this trial might be open, and they may find that this trial might be available at certain sites, however, because the trials stop-and-go, by the time a patient gets to those cancer centers for the trial, there may not be a seat in that trial for the patient.

Rubin: Got it, so—not all trials are run at all cancer centers, and not all trials at certain cancer centers have open seats, just if somebody wants a seat. Like, they have to qualify, it sounds like.

Tsai: That's correct. And there's often a waiting list as well.

Rubin: No kidding.

Tsai: And therefore, you know, the analogy I like to use is like a flight. Just because you know that's a flight from Phoenix to New York doesn't mean there's a seat on this flight. So, a clinical trial may exist at a certain cancer center, but we don't know—or, it’s hard for patients to know—whether there's a seat available.

Rubin: So, how does the patient find out? What's their best course? Is it ‘act fast’ or go see multiple doctors or what do they do?

Tsai: So, unfortunately, most patients depend on their oncologists, the local oncologists.

Rubin: Okay.

Tsai: But, unless the oncologist is directly involved in research, it is very difficult for the oncologists to guide them in the proper directions. Some of the resources can include clinical trial and navigators. So, for example, American Cancer Society has a nursing navigator.

Rubin: Okay.

Tsai: And at HonorHealth Research Institute, we're actually the official national clinical trial navigator for the National Science Foundation. So, we receive phone calls from patients across the country inquiring about trials—not just at HonorHealth—but across the country, around the world.

When Should A Person Start Looking Into Clinical Trials?

Rubin: So, would it be good advice to somebody who has cancer and may have advanced cancer that they meet with somebody like yourself or yourself sooner than later? Meaning they're currently engaged in treatment, but their oncologist is not quite sure if it's working, or they haven't had their follow-up and a lot of people want to be proactive—are they allowed to come see you at that time?

Tsai: Absolutely, I think that's exactly right, I actually recommend that, because there are some trials that are unique where preparation is needed. So, for example, we currently have a clinical trial utilizing a personalized vaccine.

Rubin: A personalized vaccine.

Tsai: That's exactly right. So, we biopsy the cancer and by identifying neoantigens, a vaccine is produced specifically for that patient's cancer.

Rubin: That's a lot of work!

Tsai: Eight weeks.

Rubin: Wow, so, it takes eight weeks to prepare and then person can get treated—it’s multiple treatments?

Tsai: That’s correct, it’s multiple treatments.

Rubin: Interesting. Well, we talked about immunotherapy—we know that the immune system is basically your first and last defense against cancer. Generally, immunotherapeutics is something considered quote like “off the shelf” like: ‘this is what the drug is, you get it, let's see if it works,’ but what you're talking about is really a next level. This is specifically against the person's own cancer and only that cancer.

Tsai: It's very exciting.

Rubin: Boy…I would, I would love to keep in touch about that one.

Something To Be Really Careful About

Rubin: I do want to talk about the integration of naturopathic and conventional oncology, when it comes to clinical trials. One of the issues that we’re faced with is—there's an ethical issue sometimes. If a person, a patient of mine, or a new patient goes on a clinical trial, the company that sponsors it for whatever reason might not allow any other therapeutics, or they might put significant and/or severe limitations on what I as a naturopathic oncologist is allowed to do. I think it's important that any other practitioner that the patients see who's not directly involved in the clinical trial be very open about the clinical trial. My question about this is: should a patient fail to let me know, and I had no idea, and I had them on a certain protocol that perhaps was not allowed on the clinical trial—could that patient be at risk for losing their spot?

Tsai: Absolutely they can.

Rubin: So, they could get disqualified.

Tsai: That's correct, and that disqualification may involve in the initial phase as you're looking to get into a trial but also after they get into the trial. The reality is that, as you know Dan, medications can interact in a variety of different ways and these lists can be long. You and I never have this issue, because you’ve been so great at communicating with us.

Rubin: Thank you.

Tsai: But, I've seen cases where patients start a new medication weeks before they get on thinking that everything is fine, but the reality is, it disqualified them from a trial. So, maintaining that vigilance is very helpful.

Rubin: It's great—it's great for the patient, and it's something it's just something to, if you're a patient, and you're interested in a clinical trial, or you're on one, and you're also engaged in integrative or naturopathic or, you know, non-conventional means, you're seeing other practitioners, it really is very important to be open to all your practitioners about what you're doing. Especially because those are really valuable spots, and also in the name of science. There's a reason that a clinical trial is designed the way it is and we, you know, want to know cleanest results. If something's going to interfere, that could affect, you know, other therapeutics down the line.

Is There Something You’re Most Excited About With Clinical Trials?

Rubin: Are there certain, not particular trials per-se, because I know that some stuff you can't divulge; but are there particular areas that you're most excited about?

Tsai: Yeah, I think you described very well about the medication interactions and even in naturopathic medicine, from a natural resource, these are actual medications, you know, some chemotherapy are actually from tree bark, like Taxol. One of our trials is looking at a combination of a synthetic but from natural ingredients such as curcumin and harmine.

Rubin: Curcumin and harmine.

Tsai: That's correct, and we are currently undergoing a clinical trial to look at a variety of those combinations.

Rubin: Exciting, I mean that's that's amazing. That shows that it really is, I think, a great time for integrative medicine, conventional medicine, there's more—seems to be more work being done in small molecules, more physiologically related agents and some, you know, naturally pointed agents—immunotherapies than really just the reliance on standard-type chemotherapeutic activity drugs.

Tsai: Absolutely.

Rubin: Is that reasonable?

Tsai: Mm-hmm, absolutely.

Can You Ask About Clinical Trials Without Hurting Your Oncologists Feelings?

Rubin: Regarding clinical trials in your practice, any other issues that you've run into about communication or patient access?

Tsai: Yeah I think, you know, there are a number of things, but but one of the major factors that I hear from patients is their anxiety and hesitation about approaching their oncologists and doctors in seeking more treatment options.

Rubin: They don't want to hurt their feelings per-se…

Tsai: Exactly, and you know, traditionally, medicine has been a very paternalistic environment, but in this day and age, as you had described early in the conversation, it's just so hard to you know everything that you need to know, and so I would encourage patients to ask more questions. A second opinion should be a routine process if that's what you're desire is.

Rubin: I think it's a great idea, makes sense.

Tsai: Exactly, and therefore, I think they should bring the information to the doctor if there's a trial that they're interested in, or simply just to ask ‘hey, what about clinical trials?’

The Value of a Team Approach

Rubin: I really, really respect the work that you do and the way I see it is you practice standard of care, and you also practice clinical trials, and from my perspective when you're involved in clinical trials and what I tell a patient if I'm referring to you or one of your colleagues or your partners is that you know what maybe didn't work. You've seen those clinical trials and some of that researcher that news doesn't necessarily trickle down to the community oncologist. You know what the current standard of care is, and you also know the pathways that are upcoming—what's in the pipeline. And you're seeing these things in action, and those findings don't necessarily become standard of care, or you know trickle down into every community, and I just tell patients you know when I ask them to come see you is that you have that outlook. And I think it's really valuable, especially for somebody who's looking for a treatment change.

Where Are People With Cancer Treated in America

This illustrates the need for the various roles physicians play in the treatment and support of those with cancer.

Tsai: Well, thank you for the generous comments, but the reality is you and I are just teammates on the same team, which includes their oncologist. No one can know everything there is to know, and 80% of America's cancer patients are treated in a community, not a tertiary cancer center. So, what that means is that there's a place for doctors who do clinical trials and research, and there's a place for doctors who are on the front lines in the community, and there’s also a place for additional specialists and the great work like yourself do to help the patients.

Rubin: Well thank you, this has been wonderful to be able to sit and have this time set aside to learn from you about what it's like in the world of clinical trials and it's been very educational for me and I appreciate I know our audience will appreciate it too. Any couple take-home notes for our audience out there regarding clinical trials, access, advocacy?

Tsai: Other than what we've described, I would say keep going, keep asking questions, don't ever hesitate to have a conversation about it.

Rubin: Wonderful. Well, thank you very much Dr. Tsai, this has been wonderful

Tsai: You're very welcome.