Texas Tech Health Check
Texas Tech Health Check
Clinical Trials Explained: Bridging Discovery and Treatment Through Research
Clinical trials are the future of medicine, to borrow a phrase. Every medication on the market right now was at one point in time subject to a clinical trial. Our guest for this episode, Jennifer Kesey, Ph.D., associate managing director for the Clinical Research Institute at TTUHSC, explains to us what a clinical trial is, the different types of trials and how to participate in one.
For more information on how to volunteer for a clinical trial visit: https://app4.ttuhsc.edu/CRIVolunteer/
Melissa Whitfield 0:10
Hello and welcome back to Texas Tech Health Check from Texas Tech University Health Sciences Center. I'm your host, Melissa Whitfield. We want you to get healthy and stay healthy with help from evidence based advice from our physicians, healthcare providers and researchers. I am often asked about clinical trials when I tell people where I work. So for anyone else wondering about them, also Dr. Jennifer Kesey, associate managing director for the Clinical Research Institute here at TTUHSC answers our questions from exactly what is a clinical trial and why are they important in medicine and healthcare to who can participate? How do they ensure the trials are safe, and most importantly, is there a monetary compensation?
Melissa Whitfield 0:55
Dr. Kesey, welcome to our podcast.
Dr. Jennifer Kesey 1:11
Thank you. I'm so happy to be here.
Melissa Whitfield 1:13
Well, we're glad to have you on. How are you today?
Dr. Jennifer Kesey 1:15
I'm doing really good. It's a Monday, but still good.
Melissa Whitfield 1:18
Well, we're happy to have you, and if you could tell our listeners a little bit about yourself, what you do at the Health Sciences Center and how you became involved with the Clinical Research Institute,
Dr. Jennifer Kesey 1:27
Sure, my name is Jenna Kesey. I'm a longtime nurse and actually a family nurse practitioner. I've been here at the HSC and also working in clinical practice for about 23 years now. I have a lot of experience in the care of burn injured patients, trauma patients, surgical patients, and in that along the way, I've been involved in research for many years with different surgeons that I've worked with, and that all led me here to this position where I'm the managing director of the Clinical Research Institute.
Melissa Whitfield 1:57
Well, as I said, we're happy to have you on because one of the questions I get when I tell people where I work at is they ask me if we have any clinical trials going on, and I always say, I don't know. I have no idea. So we're happy to have you on. So what exactly is the clinical trial? And are there different types?
Dr. Jennifer Kesey 2:14
There are different types of clinical trials. So a clinical trial is a very special type of investigation where we are looking to determine if a treatment or a device or a medication that's used to treat different diseases and conditions for humans, whether or not it's effective. And so that's the basics of what a clinical trial is. And there's different phases and different types, and we do all different types here at Texas Tech.
Melissa Whitfield 2:38
Can you explain the different kinds of trials?
Dr. Jennifer Kesey 2:42
Yes, so there's two different broad categories. There's investigator initiated clinical trials. This is where our physicians and scientists come up with different ideas of treatments, procedures, medications that might be helpful for their patient population. And they come up with an idea on their own, and they either develop the treatment, medication or therapy, and they apply for a clinical trial so that they can investigate to determine if that type of treatment is effective for their patient population. But the idea all comes from our researcher or our physician scientist working right here at Texas Tech. So those are investigator initiated trials. Another type of clinical trial is an industry sponsored clinical trial. Those types of clinical trials is where there's people who work in the healthcare industry. So that may be pharmaceutical companies, it may be medical device companies, and they have developed a product or a treatment that they want to be used to treat different diseases or conditions for humans, and they will partner with Texas Tech and bring clinical trial opportunities to our patient population.
Melissa Whitfield 3:50
Why are clinical trials important in medicine and in healthcare?
Dr. Jennifer Kesey 3:54
Clinical trials are incredibly important for healthcare because they are the foundation of how we create new therapies. So if you think about all of the different types of therapies and medication used to treat conditions or diseases that exist right now, at one point in time, all of those therapies and medications were subjected to a clinical trial. So clinical trials really are the future of healthcare. So things that we are studying right now, someday will become the foundation of treatment and therapy for patients struggling with this disease or condition.
Melissa Whitfield 4:29
What are the different phases of a clinical trial?
Dr. Jennifer Kesey 4:33
So there's a lot that happens before you even get to a clinical trial. Oftentimes, investigators will do years of types of research to determine and investigate and identify that this you know, molecule or treatment or medication is going to be effective. Many times, there's animal studies that may or may not take place here at Texas Tech, depending on the study. And so lots of things go into developing and establishing whether or not this is even safe. Is to be applied to human subjects, and all of that has to go through the FDA. The FDA governs the safety of clinical trials that occur in the United States of America, and so in order for a clinical trial to begin, the FDA has to already deem that this is likely going to be very beneficial to patients suffering with that particular disease or condition. So you can apply to the FDA after you've done a lot of foundational work and research to determine that this is likely going to be very effective, you apply for the FDA, and phase one really has a focus on safety. This process takes about one year, and usually there's a smaller number of subjects. Sometimes healthy volunteers will come, and sometimes it's patients with a specific disease or condition, and this is strictly focusing on safety. Is there anything harmful about this medication that we're going to be giving to patients? And so after that initial assessment or phase one trial, then you send your data to the FDA and verify that it is indeed safe, and then you move forward to phase two. Phase two is typically where we are assessing the effectiveness of that medication or treatment. So this would be oftentimes set up with things called a placebo. So you may have one patient group that gets the trial medication or the trial treatment, and another patient group that gets a placebo, and those patients are going to be deidentified, it's randomized. There's a lot of checks and balances, lots of rules that are applied to this type of a clinical trial, and that typically has, you know, several 100 patients, and that process usually takes a couple of years, so about two years, maybe three. So then after you go through phase two trials. You submit all of your information back to the FDA, and they determine, yes, it was, in fact, you know, efficacious. Yes, there is benefit to this. We can continue to move forward. And then we'll move to a phase three trial, which is where we compare that new medication or treatment to the standard of care. So this usually involves 1000s of patients. So this takes usually one to four, maybe even five or six years. So it's a very long process where many, many patients are given an opportunity to participate and use this, what we'll call an investigational treatment or medication, and then they really track a lot of data to ensure you know, is it better than the standard of care, or is it less effective than the standard of care? And then again, you submit all of your information back to the FDA. So usually after phase three is when the FDA will give the FDA approval and your product will be able to go to market. But once your product goes to market, and so that means it would be available for anybody. So your any doctor or provider could prescribe this particular medication or treatment for your disease or condition, then it would go to phase four. And phase four trial is after FDA approval, and that's where they continue, even though it's FDA approved, we always want to err on the side of safety, and they continue to collect data on how the patients are doing or any adverse events or side effects that may be taking place, so they continue to collect data for one or more years after the medication has already been approved, so that we can make sure that you know things are going smoothly and that no unanticipated events are taking place. So that's a brief explanation of the four phases of a clinical trial for FDA?
Melissa Whitfield 8:24
Well, no, that's good because it gives us an idea of how long it takes. So how long do clinical trials typically take?
Dr. Jennifer Kesey 8:31
So if you add it all together, including your foundational research, before you even apply for a clinical trial, I can see it can take a decade or more. We have investigators right now, very brilliant scientists working at TTUHSC, in the basic science lab that are investigating new molecules to treat diseases that are affecting people that we love. And they're putting putting those molecules and doing all of the tests to begin this process so that hopefully those medications and treatments and different molecules will become clinical trials, so that we can determine whether or not they're effective in treating diseases that people we love are suffering with.
Melissa Whitfield 9:11
What kind of clinical trials are done here at TTUHSC?
Dr. Jennifer Kesey 9:15
So we have researchers here at the HSC involved in all different phases, everything from basic science and preliminary work, phase 1234, you know, across the gamut.
Melissa Whitfield 9:28
What safeguards are in place to protect the safety of the trial participants?
Dr. Jennifer Kesey 9:32
Well, first and foremost, I'll say that participation in any clinical trial is 100% voluntary. All patients have an opportunity to participate in a clinical trial, but no one is ever forced to do so. So even if you are offered an opportunity to participate in a clinical trial, it's incredibly important that you and all of our listeners understand that if you say no, then it will not affect your relationship with your provider in any way. And it won't affect the fact that we're still going to give you really great care here at TTUHSC. And so that's probably the most important safeguard. In addition to that, there's a lot of checks and balances that we go through in order to ensure that we're focusing on patient safety and ensuring that safety is our first priority. There's a lot of checks and balances and rules that the FDA mandates, but also here at TTUHSC, we have to make sure that the clinical trial opportunity is a good fit for our patient population, because if this trial isn't a good fit for our patient population here in West Texas, then it's not a good opportunity for us. We want to make sure, as a provider and as a scientist that we're offering trials that match what our patients need, we always want to have a clinical trial that fills a gap in the patients that we're caring for. So we're not going to offer clinical trials that aren't a good fit for our specific population here at the HSC. And then additionally, we also have what's called an Institutional Review Board, which is a board of scientists and other persons here at TTUHSC that whose entire focus is on ensuring human subjects research safety. And so their focus is making sure that the participants in a clinical trial or really any other research taking place here at the HSC are safe, and that we're providing for the safety of those patients at all times
Melissa Whitfield 11:26
Who can participate in trials and how do we sign up? Is there a monetary compensation?
Dr. Jennifer Kesey 11:32
So depending on the trial, that's a very valid question. Depending on the trial, some trials offer monetary compensation for participation. Some trials may offer help with travel. So if the trial requires you to come here to, let's say, the Lubbock campus of the HSC, then the trial may offer travel assistance or money to help with travel. Because, you know, we serve patients across a very, very large area, and we have a lot of rural patients as well, and it just depends on the trial. So some trials don't offer any monetary compensation. It just depends, and it usually matches with the level of complexity that the trial requires. So if you are engaged in a clinical trial that requires a very complex treatment regimen, then the sponsor would be more likely to offer a monetary compensation, but it just depends, and it's completely trial dependent. Different ways that you could offer to participate. At the CRI we have a website where you can let us know that you are interested in participating in future clinical trials, and we'll gather a little bit of basic information about you, and that information may include different diseases or conditions that you may be interested in participating. We also have an opportunity for people to participate in healthy volunteers trials, which is where different types of trials may ask for information from healthy volunteers so that they can add that as part of their basic science research.
Melissa Whitfield 13:01
What are two or three additional things or something you'd like to stress to educate people about clinical trials?
Dr. Jennifer Kesey 13:10
I think it's important to know one of them. I think I already stressed, but it can't be overstated. It's completely voluntary, and participating in a clinical trial is a choice. It's an informed choice. So if you are offered an opportunity to participate in a clinical trial, then we would talk to you about what the trial is about, what the what we're investigating, talk to you about the medication or treatment or what side effects may take place, and we'll go through an entire conversation about exactly what to expect. And then you can make what's called an informed decision, and if you choose to participate, then that's wonderful, and you're contributing to research that may, in the future, help lots of people. And if you choose not to participate, then that's entirely okay, and we're still going to give you great care. So I know that that's important, and I've covered that. The other thing is clinical trials is it's a very complex process, but we have experts right here in West Texas at the HSC that do this all the time, and to me, participating in a clinical trial, or us as an institution, bringing clinical trials to the population is is one of the ways that we're providing innovative care. So if you or a loved one is struggling with a disease or a condition that's difficult to treat, or maybe an unusual, uncommon disease or illness or condition, or maybe it is something that is common. Us offering you an opportunity to participate in a clinical trial is one method of innovative treatment. So again, these are the treatments of tomorrow. This is how we develop medications and treatments so that we can give great care, not only now, but looking into the future. So to me, participating in a clinical trial is an opportunity for that.
Melissa Whitfield 14:52
Is there anything else that you'd like to add?
Dr. Jennifer Kesey 14:57
I just really appreciate the opportunity to come here and talk about something that's near and dear to my heart. Our mission at the CRI is to assist with and facilitate research taking place across all of the schools, across all of the campuses for the HSC, and it's so near and dear to me. I myself have been a clinical trial participant before, because this is the future of medicine, and I'm just really happy to be a part of it.
Melissa Whitfield 15:21
Well, thank you so much for coming on our podcast and explaining to us what the Clinical Research Institute does and what the trials do. So now, when somebody asks me if we have them, I can say yes and refer them to this podcast.
Dr. Jennifer Kesey 15:32
That's wonderful. Thank you for the opportunity.
Melissa Whitfield 15:36
Thank you for listening to Texas Tech Health Check. Make sure to subscribe or follow wherever you listen to podcasts, this information is not intended to be a substitute for professional medical advice. Always seek immediate medical advice from your physician or your healthcare provider for questions regarding your health or medical condition. Texas Tech Health Check is brought to you by Texas Tech University Health Sciences Center and produced by TR Castillo, Suzanna Cisneros, Mark Hendricks, Kay Williams, Krystal Meazell and me Melissa Whitfield.