The benefits and challenges of clinical research trials.

 

 

Episode Introduction

Clinical trials can transform healthcare and the patient experience, yet they are not without their challenges. In this episode, Jim Cagliostro, VIE’s Clinical Operations Performance Improvement Expert, interviewed Todd Nicklas to discuss his experience with clinical research, including the positive impact for hospitals that participate in clinical trials, overcoming patient hesitancy, and the high cost of achieving FDA approval. 

 

Show Topics

 

• Why clinical trials matter to healthcare
• From bench research to real life scenarios
• Clinical research can reduce patient readmissions
• Trialing heart donors with Hepatitis C
• Overcoming patient hesitancy 
• The $2.6 billion cost of successful clinical trials
• The impact of COVID-19

 

 

01:55 Why clinical trials matter to healthcare

Todd said clinical research can attract patients to hospitals by giving them access to brand new treatments.  

 

‘’Physicians and patients have access to cutting edge new technologies and that's brand new technologies and medicines that maybe are a few years down the road in development, or maybe that just got approved and that hospital has it ready to go in their formulary and ready to be used. They're maybe ahead of the game versus other hospitals around their area. And that might get people excited to come to their institution. I worked in clinical research on the hospital side for about 10 years, and some patients would come to our hospital for the very reason of trying out a research medication or trying to work with a physician that's doing a trial with us with a medication. Got them excited to come to that institution versus maybe their own hospital that they're at.’’

 

 

03:56 From bench research to real-life scenarios 

Todd shared an early example of artificial hearts, trialed in a cow.

 

‘’Another great thing, I would say, is a fair amount of hospitals have translational bench research and they want to translate that into real life scenarios and putting it in patients and giving it to patients. So you see something that maybe was developed 30, 40 years ago. You and I worked at Penn State Hershey Medical Center for a few years, and I love the story in the, I believe it was the 1970s. They were working on the first total artificial hearts. And this device was pretty primitive at the time. It's developed a good bit as of today, but they put it in a cow and they have a neat story that it was a pneumatic system. It was an air compressed system and they plugged it in, it was back in the 70s, they had the plugs in and I guess some electrical problem happened, and the cow dropped like it was dead because the power went out and somebody thought to blow on the pneumatic tubing that was in the back of the machine to have the blood pump for that cow and, to bring it back to life until they get the electrical power back on. And the cow lived for weeks and months after that. But it gets people excited, "Oh, Hershey Med's doing this? And look at this neat story." And then the years to come, the cow survived, they put it in patients a few years after that, but it's doing great and people can get that now at home. They can actually go home with a total official heart and a driver. ‘’

 

 

05:24 Clinical research can reduce patient readmissions 

Todd said new medications can improve patient outcomes, leading to fewer readmissions, rehospitalizations and ER visits. 

 

‘’….Physicians that are so used to certain procedures, certain medications, certain devices, they might have good outcomes and they might do fine. But what if there's a new medication that gives them 50% better outcomes or 50% less hospital burden where people are coming into the hospital, 70% less, or pick a number. Why wouldn't that be something that's a top priority or a top consideration in your mind? I worked with the CardioMEMS device, which was a really neat device that was bought by a larger company. But at the time, it was the small company that was running it. And it's a device implanted into your pulmonary artery to measure heart pressures, and to tell you when your heart pressures are not doing well, and even if you're not symptomatically feeling that change… And the biggest reason why it got FDA approved was the fact that it was reducing re-hospitalizations, readmissions, and even people coming back for ER visits, even for heart failure. So why wouldn't that get hospitals excited saying, "Hey, we can reduce our heart failure admissions by X percent." That's less burden on the hospitals, less burden on the doctor, nursing staff, supplies, beds.’’

 

 

12:45 Trialing heart donors with hepatitis C

Todd shared his experience working in heart failure and transplant, when patients were out of options. 

 

‘’I worked in heart failure and transplant where people are at the end of their rope and last ditch options with heart failure.... Hospitals did a study where they would have patients be able to get hepatitis C hearts from donors that had hepatitis C. But the goal was that if they did receive that heart, that they could get a treatment that would immediately t rid of the hepatitis C. And it would open the doors to more options when you're waiting on a heart transplant for years, and you never know if you're going to make it to get a heart or not. I remember talking to the second patient that got it at Upenn, and he was ecstatic about how he got... I think he got a heart within two weeks of signing up with the study and it would've been months and months. So yeah, it was a leap of faith. It was a little bit of nerves with him, but he read the consent form. He talked with his physicians, he understood the safety behind it, and what he could know and not know at the present. And he made his own decision.’’

 

 

13:39 Overcoming patient hesitancy 

Todd highlighted the importance of transparency around risks and benefits for patients. 

 

‘’Clinical research is very focused still today on the patient first and safety first. You can quit a trial at any time and you can work with the physicians to do so. And I'll talk about this a little further down the road, but I think a big hesitancy is the fact that research in the past, maybe 30, 40, 50 years ago, there were times where people wouldn't tell people that they were doing... Physicians or clinicians wouldn't tell people that they were doing a trial on someone, or wouldn't be as transparent about the risks and the benefits, or maybe say, "Oh yeah, this is the next best thing, but not really tell both sides of the equation of saying, "Well yeah, but we don't know X, Y, Z about it. But nowadays, I've given patients consent forms that are 20 to 26 pages long, just to say every single thing about the study and how your data is going to be shared and confidentiality and safety, benefits, visits, little bit of everything. So I think it's really developed even the last 10 or 15, 20 years, but I think that's a big hesitancy in the past is, if you think about the Tuskegee studies in the 1930s and forties come up pretty often here. I know that was about 80 years ago, but that's a big one where people were not told at all about multiple things.’’

 

 

19:56 The $2.6 billion cost of successful clinical trials

Todd outlined the complexities and huge costs of achieving FDA approval. 

 

‘’That's a tough thing to know because one, it wastes cost and money to put all that forth, that effort, if you're not really learning a lot from it, and it's not slam dunk at the end of the day, but we don't know what we don't know sometimes. And it is speculation. There's so much money that has to go into these trials. I looked up a 2018 study, they said that 12% of drugs in clinical development stages get approved 12%. And it costs about $2.6 billion on average to get a drug from the very first stages of it being studied, maybe in animals or even before that to getting it FDA approved. So people don't understand that it takes so many different iterations of trials and money and understanding all the, how does it affect your kidneys? How does it affect your heart? How does it affect your brain? How is it broken down? How effective is it? All these studies have to be done for the FDA to make a good decision. And sometimes knowing how to asset in a protocol could make or break protocol, the development of that some people might just toss it aside and say, "Well, we can't develop that anymore because we don't have the money for it and we missed the target on this." So that's a tough one, I would say upfront.’’

 

 

23:11 The impact of COVID-19

Todd said that the pandemic showed how participation in research studies can have a positive impact. 

 

‘’I think people across the board are still hesitant to research in the sense that they think they're their Guinea pig. I came across it a lot where people would say, "Are you just trying this out on me because I'm a Guinea pig and I'm just saying yes to it?" And the misconception I think is because, until there's a big cure for cancer or a big cure for something major where people are saying, "Wow," from a societal perspective, like we really now appreciate research and understand I think COVID vaccine a little bit, but it also has some political components to it where people were like, "Look at the impact of the COVID vaccine. But then some people kind of are worried about different sides of how that data has landed. But I think when there's big things that really hit the clinical medical world where people are like, "Wow, this is great that we have research that people are willing to do." Then you get the sense of people jumping all in. We actually had that in 2020, 2021 where people are, were really banging down the doors to say, "I want to do research," because they saw how much COVID was affecting the world, and how maybe their participation in a research study could help our understanding of it.’’

 

 

Show Links

Connect with Jim Cagliostro on LinkedIn

Connect with Todd on LinkedIn

Check out VIE Healthcare Consulting

 

 

You’ll Also Hear:

 

The benefits of clinical trials for your hospital – from attracting new patients, to building partnerships with pharma companies and device manufacturers as ‘’first adapters.’’ ‘’…People will say, "Well, do I want to go to a hospital that has 10 years of experience with it, or they just started last month?" You're going to have a hospital that's really well respected in that landscape.’’

 

Taking a leap of faith: The true story of Dr Forssmann and the first (self-administered) catheterization, ‘’He actually performed the first catheterization on himself. What he did was he actually took a fully catheter and put it into a vein in his arm... Because he believed that this was a doable procedure. This was 100 years ago, 1929.’’

 

Overcoming cultural issues: why participation on a clinical trial can’t be based on patient-doctor relationships alone. ‘’There's been times where I've had to fight and advocate for my patients to say, "Hey, I don't think this patient knows enough about what they're saying yes to."

 

The red tape around clinical research and why it’s always ‘’safety first’’ for patients. 

 

Why it’s important to understand that most patients don’t meet the criteria to successfully enrol on clinical trials. ‘’I think it's like 70% of the people tend to not meet the criteria. And then another 30% to 50% tend to decline the study. So when you already take those numbers down, let's say you have 1,000 people that would meet the criteria.’’

 

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