Ask Us Anything About… Clinical Trials

Description – The video begins inside a clinical setting room at Penn State Health Milton S. Hershey Medical Center. Three individuals are standing in front of IV poles and monitors. The three individuals are looking at the camera and the individual on the left is holding a microphone. Standing from left to right is Scott Gilbert, Terry Novchich, RN, BSN, director, Penn State College of Medicine Clinical Trials Office and Dr. Neal Thomas, associate dean for clinical research, Penn State College of Medicine.

Scott Gilbert – We are at Penn State College of Medicine — welcome to Ask Us Anything About Clinical Trials. I’m Scott Gilbert. Clinical trials are a critical part of the process of approving drugs, treatments and devices. But you may want to learn a little bit more about them and that’s why we’re here today talking with Terry Novchich. She’s Director of the Clinical Trials Office here at Penn State College of Medicine. Terry, thanks for being here.

Terry Novchich – Thank you. I appreciate the time.

Scott Gilbert – And Dr. Neil Thomas is Associate Dean of Clinical Research at the College of Medicine. Dr. Thomas, thanks for being here.

Dr. Neil Thomas – Thank you, Scott.

Scott Gilbert – All right. We’re going to talk today about again clinical trials. And at any point in time, we welcome your questions and your comments in the comment field whether you’re watching this video live or on playback. We’ll get an answer for you from these two, all right? Let’s start with how clinical trials fit into that overall process. It can be a very lengthy process to approve drugs, devices and treatments. Where do clinical trials fit into that process?

Terry Novchich – They are in fact a lengthy process. In fact, there are instances where it can be up to between 15 and 17 years for a particular drug or device to get through all the approval processes before we actually see it and physicians are able to be able to provide that care. So there are multiple phases for particular types of trials and I’ll let you address that.

Dr. Neil Thomas – Yeah. It really — once the preclinical work is done, it starts with the phase one trial which basically focuses on safety either in patients with the disease or healthy volunteers. If it gets through the safety process — and about half of the medications that go through phase one actually get to phase two — then we begin to look at efficacy, how effective it is in the patient population still paying close attention to safety. If that is successful, then the large phase three trials are really the ones that you think about with a large randomized control trial where people will get a medication or get a device in large scale usually across multiple institutions across country or across the world. And that’s all extremely important and necessary information for the FDA to issue approval of a drug.

Scott Gilbert – You mentioned even half of those drugs don’t make it to phase two. Why is that?

Dr. Neil Thomas – There’s a very small percentage of potential drugs that actually make it all the way through. A lot of times the safety profile just isn’t good enough. There are too many side effects, and before phase one trials are very small and a limited number of patients, and the dose of a medication is escalated over the course of the study. If they find that the drug is not safe enough or has too many adverse effects, then that will be the end of the trial, and it will never move forward.

Scott Gilbert – Now, obviously a lot needs to happen even before a drug or a treatment can make it to the clinical trial phase. Can you talk about that? What happens in that long period of time leading up to clinical trials?

Terry Novchich – Well, we do have what we call the preclinical work. It first starts with somebody having the idea of a particular compound or particular treatment for an injury or for an illness. So it takes again many years to be able to develop those ideas and get through that preclinical work to then provide just truckloads of information to the FDA to then be able to want to move those into the realm of human subject research.

Scott Gilbert – You’re watching Ask Us Anything About Clinical Trials from Penn State Health and Penn State College of Medicine. I’m Scott Gilbert along with Terry Novchich and Dr. Neil Thomas. We welcome your questions in the comment field of this Facebook post, and we’ll pass those along to them. Whether you’re watching this video live or if you’re watching it on playback, we also encourage you to share this video if you find the information in it to be useful. Terry, you mentioned a bit about the FDA and their involvement. I know there are a lot of approvals involved both at the FDA and right here on the Hershey campus that need to happen throughout the process. Can you just tell me a bit about that?

Terry Novchich – Right. We have a human subject protection office. They’re our administrative arm of what we call the Institutional Review Board, the IRB. And our IRB mandated by regulations from the FDA includes scientists, nonscientists — so for example, I’m a member of one of our IRB’s, and more importantly we even have community volunteer members who are able to give us that different kind of a focus when we review these clinical trials so they go through a very robust review here institutionally to determine is the science really good? Is it a good fit for our community, and we have the ability to be able to do this study and do it well.

Scott Gilbert – How rigorous of a process is that with the IRB?

Dr. Neil Thomas – It’s very rigorous. Patient safety is always number one, and if the scientific integrity or the question isn’t good enough, then that gets weighed into it as well. But the IRB is the board that on our campus and across all places around the world, ethics boards or IRB’s review the potential benefits and the potential safety in ways that before things are moved forward.

Scott Gilbert – And then how do those approvals interrelate with the approvals needed from the FDA?

Dr. Neil Thomas – Well, they are really required before the — any clinical trial moves forward. So before even a phase one trial can get started, it requires IRB approval at the institution where subjects will be recruited or at any institution where subjects are recruited. As the phases of the therapy move forward, each protocol will be reviewed by the IRB, and that determination will be made.

Scott Gilbert – So people getting involved in a clinical trial may wonder well, “I don’t want to be the first person to try this medication,” but really a lot of careful steps have been taken to ensure the safety before that then.

Terry Novchich – There have been, and of course, that’s part of why we talk a lot about healthy volunteers, and many of these early phased trials, they are in fact the trials conducted in healthy volunteers. So that’s individuals without the actual disease or condition, and they’re just a key part to the research process.

Scott Gilbert – Sure, and healthy volunteers are the focus of our Penn State Medical Minute. You can find that online at PennStateHealthNews.org. That was just in this past week. We encourage you to check that out. And also while we’re on here, we want to tell you that clinical trials will be the focus of a TV show this Thursday evening, April 27, on WHTM TV, ABC 27, a special show where you can get your questions answered about clinical trials. 7:30 p.m. this Thursday night. So make sure you check that out. Let’s talk a bit more about healthy volunteers because that’s an interesting part of the process. What is the role of a healthy volunteer in the typical clinical trial?

Dr. Neil Thomas – Well, there are different aspects of healthy volunteer research. Some of it doesn’t relate at all to medications or treatments. Really understanding disease. So our Heart and Vascular Institute in the College of Medicine has a large number of trials where healthy volunteers are recruited and have certain stimuli applied to them and to determine the body’s response. That’s incredibly important to understand the mechanism of disease so we can develop these targets. Healthy volunteers also can be part of the early phase clinical trials particularly phase one trials. I always tell the story as a medical student, I was part of a phase one trial of a medication that’s now FDA approved. And I spent a couple of nights in a research center having my blood drawn and receiving this medication. So it is something that is necessary to move forward and sometimes for medications, healthy volunteers need to be tested before patients with disease.

Scott Gilbert – Must be neat knowing that you had a small part in that process of allowing that drug to become — put on the market.

Dr. Neil Thomas – It makes it easier for me to support clinical research and especially healthy volunteer research.

Scott Gilbert – Terry, talk to me about some of the reasons that people who have a given illness or condition should think about looking for the available clinical trials out there. What are the benefits to them?

Terry Novchich – Well, in many instances, it provides the ability for an individual to receive a particular treatment or of a therapy that they may not otherwise have available to them. It allows that individual to have a really — should have a robust discussion with their care provider to say what are the options out there for me with my particular condition? And to be able to be a part of that.

Scott Gilbert – Now, there is a control group in these studies, right? So I mean, there’s a chance that the individuals enrolling will get the actual treatments. Some may get placebo, right?

Dr. Neil Thomas – In the later phase studies, some phase two and all of phase three, most phase three studies, there is a placebo group. And so the only way to scientifically tell if a medication or a therapy has an effect is to compare it to what is standard of care. So I think it’s important to realize that patients with disease will receive standard of care. They won’t receive nothing if there is a medication or a treatment that is effective for that disease. And the placebo will be in addition to what they would normally receive.

Scott Gilbert – Very important point. You’re watching Ask Us Anything About Clinical Trials from Penn State Health and Penn State College of Medicine. I’m standing alongside Terry Novchich and Dr. Neil Thomas, and they welcome your questions here in the comment field below this video whether you’re watching live or if you’re watching on playback. We’ll make sure we track them down and get an answer for you. I would think another perhaps less tangible but still very important reason to be a part of a clinical trial if you have a given condition would be knowing the good you can do for patients with that condition in the future, right?

Terry Novchich – That is correct. It may be that at the current time that you are taking part in a clinical trial it may not have benefit to you, but know that you are actually contributing to perhaps certainly the scientific knowledge and the body of work for that particular condition that down the road may benefit others, absolutely.

Dr. Neil Thomas – Yeah, and I think it’s important when you ask — unfortunately only one percent of the U.S. population participates in clinical trials. But when you ask the people who have participated why they did, many times it was to further understanding of the disease and to develop treatments for the future, not for them.

Scott Gilbert – Talk to me a little bit about study finder. That’s a website studyfinder.psu.edu. That’s an important link to remember. We encourage everybody to check that out because that will tell you about all the clinical trials available here at the medical center, right?

Dr. Neil Thomas – Yes.

Terry Novchich – Go ahead!

Dr. Neil Thomas – So study finder, we’re lucky enough to have received an award from NIH called the Clinical and Translational Science Award. We are one of 64 institutions across the country that has those awards, and it’s an infrastructure award and through that award we’re able to borrow technology from the University of Minnesota to develop phase one of study finder, which we presently have where it will draw information about our phase two and phase three clinical trials. What we’ve worked on since then is phase two of study finder which will be live as of June 1, and that will be all of our clinical research including healthy volunteers survey studies, really anything that requires IRB approval that is recruiting human subjects will be one place, and that will be studyfinder.psu.edu.

Scott Gilbert – Sounds like a great resource, something we should all check out then. Studyfinder.psu.edu. Well, I really want to thank both of you for being here today to talk about this. I guess when we think about the future and what happens after a clinical trial, there is one more question I wanted to ask about. What does happen? Let’s say in that four phase process, let’s say a drug or a treatment makes it through all four phases, what happens then?

Terry Novchich – Well, then at that point depending on what it is, the drug or device then becomes available out in the — for the providers to be able to prescribe. There are some instances, we are seeing a little more of the FDA requiring what we call phase four followup studies, and that is again from a safety perspective to be able to collect more and more data when you get out to conducting or now providing this medication or treatment to a larger group of patients then just those that were in the trials. They want more information. So we’re seeing more of that as well.

Scott Gilbert – Great. Anything else you guys want to cover we didn’t touch on?

Dr. Neil Thomas – No. I think we — we hit all the high points.

Scott Gilbert – Good deal. Well, thank you both very much. We have Terry Novchich. She’s the Director of the Clinical Trials Office here at Penn State College of Medicine. We have Dr. Neil Thomas, the Associate Dean of Clinical Research here at the College. They both joined me for this addition of Ask Us Anything About. Even if you watch this video on playback, please do add those questions to the comment field, and we’ll make sure we get answers for you that we’ll also answer in the comment field. Feel free to share this video if you found the information helpful and make sure you subscribe to the Medical Center Facebook page so you can be notified about future editions about Ask Us Anything About. Thank you very much for watching Ask Us Anything About Clinical Trials from Penn State Health and Penn State College of Medicine.