Topic: The Benefits of Clinical Trials
Melanie Cole (Host): Welcome. This is Check-up Chat with EvergreenHealth. I'm Melanie Cole. And today, we're talking about clinical trials. Joining me is Dr. Pinky Agarwal. She's a movements disorders Neurologist at EvergreenHealth and Co-Chair of the Healthcare Outcomes and Disparities Working Group of the Parkinson's Study Group. And Dr. Ted Brown. He's a Rehabilitation and Multiple Sclerosis Physician and the Director of Neurorehabilitation at the MS Center at EvergreenHealth. Doctors, thank you so much for joining us today. Dr. Agarwal, I'd like to start with you. Tell the listeners what is a clinical trial?
Pinky Agarwal, MD (Guest): So, a clinical trial is a means of trying out the safety as well as the benefits of experimental medication that is in development for clinical conditions. They are not yet in market, most of the time and we are trying to see if this is something that's worth developing and that could help that patient population. Sometimes, they are also conducted for medications that have recently been launched and the FDA is trying to track how it works or how safe it is in real life situations outside of clinical trials.
Theodore Brown, MD, MPH (Guest): And I'd like to add that occasionally it's repurposing of a medication that's already approved in one condition or disease and it's being studied in another condition.
Host: Dr. Brown, tell us then, who participates in clinical trials and what are some of the benefits of participation?
Dr. Brown: Well adults with a specific condition, disease or symptom that the investigators are trying to study. So, it can be anyone who would meet the enrollment criteria which are extremely important so that you make sure that you're studying the right population. Someone who has the condition that you want to study.
Host: Dr. Agarwal, we've all heard some common misconceptions about clinical trials whether they are getting a placebo or what are some important questions that people that are considering a clinical trial should ask themselves and tell us about some of the misconceptions and questions you've received.
Dr. Agarwal: So, one of the common misconceptions can be people can think oh I'm being used as a guinea pig for developing of a drug. But actually, clinical trials can have several benefits for the participants. One, it can be that you can get access to a drug that's not yet available in the market. And sometimes, it can be as early as three or four years before it ever comes to market. While people are participating in clinical trials, they get extensive testing. They get access to sometimes EKGs, cardiac monitoring, brains scans, and typically, these are at no cost. They also get a long time inside the clinic where they can be monitored for longer periods of time than in a typical office visit.
And all of this is typically at no cost, so people can get safe access to medications not yet in market at no cost. And oftentimes, they can continue on the meds until the med comes to market. And oftentimes, they can have either genetic testing, which is not even available in market, to see what kind of reaction they have to these meds. Some of the trials we are doing right now for possible neuroprotective benefit. Right now, at least for Parkinson's Disease; we have no neuroprotective meds available in the market. Some of the meds we are looking at are to see if it could possibly slow progression of Parkinson's Disease.
Host: Isn't that amazing? Now some of the misconceptions I've heard over the years Dr. Brown, have you heard this? That people wonder if they can be in a clinical trial while undergoing other forms of treatment or if they have to stop those other forms and can they work with their current provider once they join a clinical trial?
Dr. Brown: So, that's going to depend on the particular protocol. For example, in multiple sclerosis, there may be a trial which involves an immune therapy that really has significant effects on the immune system and so typically, in those studies, there will be a need to control other MS medications, usually by having the patient off of other drugs. So, that will be defined in each research study, whether other medications must be continued as they are or whether medications must be discontinued prior to participation. So, it just depends on study to study. But patients generally can continue their usual care and typically this is something extra that they are doing beyond. But it will depend from study to study.
I want to circle back to the misconception about am I a guinea pig. It's really important that people understand that they really are, and we try to keep them informed and in control. It's voluntary. They should understand what we're doing every step of the way and then at any time point, they have the right to decide if they still want to participate or if not; they are never trapped in the situation. It is always something that is only with their consent to go forward.
Dr. Agarwal: And I would add that they can continue seeing their treating doctor. We always try to stay - the research doctors will typically stay in touch with the patient's treating doctor. So, if some question comes up along the way, is this medication – say a patient has an infection and they need an antibiotic and there's a question if that's allowed with the trial. We'll stay in touch with the treating physician and guide them through that so that they can continue having any procedures or urgent meds that are needed so they can continue seeing their treating doctor and see the research doctor in addition.
Dr. Brown: And we want continuity of care too so that at the end of the study, because all these studies are going to end; we want them to have their care provider in place to carry on from that time.
Host: Those are such important points and thank you for clearing that up for the listeners that they can opt out at any time. Dr. Brown, what's informed consent? What do they have to go through to get involved in a clinical trial?
Dr. Brown: Well we want the patient to understand the expectations of the study and that means reading something about what is being studied, what is the intervention and then what are the risks and the potential benefits of that intervention and then what are the requirements in terms of the visits, the timeline for the patients. So, all of that is provided in the informed consent which is usually a reasonable packet of information which is written at a grade level that an average person can understand. And then anything that they don't understand, we want them to be asking questions and make sure that they're fully informed and understanding the study when they agree to participate.
Dr. Agarwal: And in addition, consenting in ongoing. So, it's not that a patient signs a consent and then they are stuck with being in the trial. Any time during the trial, if the patient decides it's onerous to them or they have something else going on or they don't have the time commitment; then they can withdraw consent at any time without any negative repercussions.
Host: I'm so glad you both cleared that up and Dr. Agarwal, that was such a good point. Now you mentioned neuroprotective and medications for MS, Parkinson's, what about for cancer patients? Is it any different?
Dr. Agarwal: At least in our center, we are not doing cancer treatments. We are just doing neuro treatments. But I would say in general, when IRB or FDA clears a clinical trial there is always noninferiority meaning you don't want the patient to be any worse off from getting the clinical trial as compared to anything available in the market. That way, patients' safety is never compromised. So, the patient, even in a cancer treatment, wouldn't be offered something that doesn't have same potential benefits as something approved in the market already.
Host: Dr. Brown, do patients pay to be in clinical trials?
Dr. Brown: Typically not. Usually, there is either no expense on the patient's part to participate or there may be some payment to the patient for aspects such as transportation to and from the center. So, most studies there is no payment by the patient to participate.
Dr. Agarwal: And in addition to transportation, sometimes there can be some reimbursement for the patient's time or for the caregiver's time if there is significant added time or effort needed on their part to participate in the trial.
Host: Such interesting work you're both doing. So, Dr. Agarwal how does someone know if they're eligible to join a clinical trial? What do they have to go through? Tell us this process.
Dr. Agarwal: There are numerous websites that are available that post clinical trials in the area. So, patients can go to www.clinicaltrials.gov and put in the condition that they are interested in and that will oftentimes pop up with the clinical trials that are going on in their area. Sometimes the local advocacy groups will publish the local clinical trials. In addition, when they go and see their provider; they can express their interest in clinical trials in which case the provider will often connect them with either trails going on in their center or at other nearby centers. So, the patient just has to express interest.
Currently, we have some Parkinson's trials going on in which pretty much any patient with Parkinson's who is interested can participate provided they have consenting ability. So, there are numerous trials out there and a lot of them are under-enrolled. These trials are time sensitive and if patients with conditions express interest, oftentimes they can be matched up with a trial that they might be a candidate for.
Dr. Brown: There are also support groups or self-help groups, peer groups of patients that often there will be someone within a group who has some knowledge about a study and they can share with each other. So, those groups are a good way for people to learn about what's going on, what studies are out there as well.
Dr. Agarwal: And actually in addition, nowadays, some sponsors or centers will also do social media advertising. So, if patients are part of some groups or some virtual groups say on Facebook or somewhere else; sometimes they'll get contacted for clinical trials through social media too.
Host: That's a really good point in this day and age of social media and where clinical trials really have the ability to transform a disease state or save a life. It really is an amazing way to communicate. Dr. Agarwal, I'd like you to summarize for us clinical trials and what you would like the listeners to take away from some of the amazing studies that you've been doing and what you want them to know about clinical trials.
Dr. Agarwal: So, clinical trials are the only way new medications can be brought to market. Initially, when we do phase one trials, you can tell the patients they can volunteer to demonstrate the safety of a product. But once it comes to efficacy, meaning does it actually help the affected population, only patients with that condition can participate and help with the development of a new drug. So, if we want newer meds to come to market, meds that are more effective, maybe safer or meds that slow disease progression; the only way that's going to happen is if patients with that condition participate in clinical trials.
Host: Before we wrap up Dr. Brown, any final thoughts on clinical trials and some of the amazing research that you are doing there at EvergreenHealth?
Dr. Brown: Well I would also add that we have many trials that are symptom management. So, we are maybe not treating the underlying disease, in our case, multiple sclerosis; but symptoms related to that disease involving mobility, strength, fatigue, pain, or other aspects of symptom management. So, the treatment and the research study might not be focused around treating the whole disease, but just trying to make life easier for someone to participate in because that can make a big difference as well.
I think that people should always think about – the first question they should ask is what am I looking for, why do I want to do this? we like people to go into it partly for altruism because as Dr. Agarwal said, it does really make a difference. We can have a great protocol but if we can't get patients to enroll, that study will not succeed. And then secondly, it's does the person – is it the right time in their life? Are they stable? Are they stable medically and emotionally to participate? Do they have the time? Because it is a partnership between us and the patients and so we have to make a full commitment to them, but we also ask that the patients once they agree to participate, that they give it their best effort.
Dr. Agarwal: And oftentimes, there's a concern that in a clinical trial, would I be on a placebo. But in all the trials in which even the placebo arm; the patients tend to do better. So, whether the patients get active drugs or placebo; both arms tend to do better than when they entered the trial.
Host: It's great information. Thank you both, so much for coming on and clearing up so many misconceptions about clinical trials and the importance of asking those questions and getting involved because that really does transform patient care. Thank you so much. And that concludes this episode of Check-up Chat with Evergreen Health. Please visit our Evergreen Health Research Program to learn more and see a list of current trials at www.evergreenhealth.com/clinical-trials. Please remember to subscribe, rate and review this podcast and all the other Evergreen Health podcasts. For more health tips and updates please follow us on your social channels. I'm Melanie Cole.