Hello and welcome to the totally clinical podcast brought to you by tech guru, totally clinical is a deep dive into the freshest trends, big time challenges and most excellent triumphs of clinical trials. I'm Hannah, your host. Join me as I chat with industry experts, trailblazers, thought leaders and, most importantly, the people benefiting from clinical research. So tune in, settle back and don't touch that dial.
It's time to get totally clinical.
This week, Chelsea McCabe joins me on the podcast. Chelsea is an experienced health care project manager who's overseen over 30 phase OneOncology clinical trials during her 10 year plus career. During this podcast, we discuss the unique set of challenges affecting phase OneOncology trials, the complexity of dealing with a ton of different portals and amendments, why patient centricity is the future of trials, and how sites are finally finding their voice.
Welcome, Chelsea. Could you start by telling the listeners about what motivated you to work for sites? So I
started working in oncology over 10 years ago. Now I started as an intern and then I went to college close to home, and I really just have always worked at a site for whatever reason.
My career has always just worked out like that. It's funny. I think everyone has their also their own unique story of how they ended up in research. For me, I met our principal investigator and him and I really connected on how we could kind of change how things were functioning from an organization structure, as well as just a growth.
And so I started working in my current role as the project manager for phase 1 research in the last five years. It has completely changed, and that's part of the other exciting piece of working site side is when you work for one sponsor, you get to know how they do things and what their portfolio is. When you work at the site, you get the exposure to over dozens of clinical research sponsors and what drugs are in development and where is the field going. And you get this whole picture.
And when I tell you, in the last five years, how first year the drugs that we were working on, now we're seeing them go into phase two and phase three. And it's so exciting to be able to sit back and think I was there for the very first dose and also where the field is going.
If we think about oncology trials, there are a lot of specific challenges. Could you expand more on these so.
Phase OneOncology trials are a very unique set of challenges. First off, for phase one in a lot of different areas, you're looking for healthy subjects in phase OneOncology trials. Unfortunately, it is the exact polar opposite. Most of inclusion and exclusion for phase OneOncology trials are that the subjects must have failed all therapies known to provide clinical benefit.
They must have failed standard of care. And so you're kind of looking for patients who, unfortunately have no additional therapy line options for them. So this brings in a whole unique set of challenges, both from a patient acuity standpoint, because the patients are assuming assuming they're very sick, but also from an overall patient care standpoint. These patients are desperate.
They have been most likely being treated for their disease for quite some time. So they're typically pretty well versed in how things work in the oncology space. And they're also kind of coming to grips with the fact that their treatment is potentially coming to an end very soon. So there's a lot of different factors that play in from a patient standpoint aside from the actual complexity of the clinical trial.
So when you have a phase one, typically when it first opens, a lot of the studies are being written that they are all solid tumors or a wide variety of tumors, and they're dose escalation and they're really just there to prove safety. We all know this, but then when you're running a phase one unit, you have to think long term and long term in the sense of where is the study going to be in 12 to 18 months? Because yes, when the study first opens, it could be for all solid tumors. So you have a sense of what you can enroll.
But then as the study progresses over those 12 to 18 months, it's going to most likely HyperFlex on one to two diseases. And so you have to be very cognizant as a phase I site that you have enough clinical trials that allow for ample amounts of slots so you can actually enroll the patients you want to enroll. However, in 12 to 18 months, you don't end up with seven studies, all enrolling sarcoma. It's a very delicate balancing act.
So
could you explain how that plays out in your unit? In our unit, we enroll about 150 patients a year on phase I clinical trials, and so we have to have a lot of studies that, in a sense, compete with each other. But in phase one, you only get a slot once every 12 or so weeks, depending on when the drugs dose escalate. So you need to have these excess studies so you have access slots, but then you also have to, again, think about, OK, well, where a study is going to be in 12 to 18 months.
Because if study B is going to be in the same place and we can't support two competing studies for sarcoma, then that's something we have to think about. So it's not just right here and right now, what can we possibly be able to do, but also in the future with the unknown? Sometimes sponsors have a lot of ideas of OK. It's definitely going to go into sarcoma and then they see a signal during the phase I dose escalation in lung cancer.
And before you know what the study is now a lung cancer study. So there's all these different challenges from a lot of different avenues from a patient perspective of clinical trial, just complexity perspective. And then the other perspective is the number of trials that you need to have with the number of sponsors that you need to have.
So we work with over a dozen sponsors and small biotechs, all ranging in their capabilities of how they function and how they run clinical trials.
So it's not like we have five studies with one sponsor. So we have a group and we know what's happening, but that sponsor and how they work, we have 10 studies with 10 sponsors, so you have to get to know each of these different players. And it makes very, very complex dynamic because we all know sponsors function a little bit differently. They all have different portals.
They all have different ways of doing things. They all have different forms and some have eligibility forms, some don't. All of that really plays in from a site perspective of how well we can work together because we have to remember that we don't just work for one sponsor. We have a whole portfolio.
And so remembering what sponsor a sponsor wants is sometimes very tricky that we need to always keep into account. So there's a lot of moving pieces. From a patient sponsor actual clinical trial. Yes, trials
can be incredibly complex for site staff, especially with the many trials you're running.
I imagine there are also a lot of amendments. Sponsors have an idea of, OK in further dose expansion. We're going to go into sarcoma. Then they see a signal in lung cancer, and now it's a lung cancer study.
All of the clinical trial amendments that go into that are essentially like opening up a brand new study for a site. If you have a sponsor that has six seven eight amendments, it's essentially like that site has opened six, seven or eight studies for one study, and it's an incredible amount of work. It's not just submitting it to your eye or B and calling it a day and waiting for the approval. If you're adding arms that requires whatever the site needs in regards to orders for patients.
So if they're electronic in the EMR, those chemo orders those lab orders a lot of times they add, you know, patient reported outcomes. So now we have to account for patient reported outcomes. If there's an update to the EKG schedule, all of these things have to be taken into account, which is essentially why an Amendment is a brand new study, and more and more sponsors are issuing amendments like their candy on Halloween. And so it really requires a ton of work for the site, and it is not just as simple as submitting to the IRB and calling it a day.
There is a lot more that goes into it that people need to recognize. So you
may have come across different technology solutions because with COVID sites have had to adapt really quickly. How have these solutions benefited the teams you manage and oncology trials generally? Yeah so during the pandemic, we were a site that was kind of still stuck in a very heavy paper era.
Yes, we had electronic medical records and the basic electronic systems. But when COVID hit, we had to completely regroup and we had never experienced remote monitoring. We had never experienced remote auditing or sponsor audits. These were all new things to us.
And so we, you know, being in the Northeast, we were hit swift and quick in March of 2020, and we in a matter of two weeks had to come up with an entire policy for how monitors can continue to monitor oncology. Research was still considered essential, and so we had to. You know, continue enrolling. We were obviously very selective in how we enrolled, but we were still seeing patients, patients were still coming to the site and how to navigate that while keeping people safe.
So we revamped our remote monitoring and by revamped, I mean, we created it. And we are actually, you know, 18 months out, we are still only allowing remote monitoring. And I can tell you those first few weeks were definitely tricky. And now we've kind of come full circle and that I think I would say we're pretty well versed in this remote monitoring world.
Now our monitors are able to access our medical records, get all of the regulatory documents that they need, all sorts that they need. And we're really kind of rocking and rolling with that. The other aspect of the pandemic and technology that really influenced us essentially immediately was also the telemed visits for patients. We had a ton of patients who obviously did not want to come to the site and be possibly exposed and vice versa.
We had staff who were like, if a patient doesn't have to come here and expose us, we don't want that either. But how do we continue caring for these patients. And how do we continue doing that safely? And so we implemented a lot of different telemed visits, which required a ton of collaborations with sponsors in regards to if it was a cycle to day 15 and we needed to do a telemedicine visit.
But the patient also needed a study kit. Well, are we taking a deviation for that study? Are we drawing the study kit in their home? What does all of that look like?
And every sponsor kind of handled that a little bit differently, which again plays into the fact of the complexity of the phase one space. Every sponsor really handled COVID very differently. So figuring out which way they wanted us to do things. But the telomeres really helped keep patients on study, keep patients safe while on study during the pandemic, and still allowed us to continue paving the way for new therapies to come through.
Now
you've mentioned sponsors quite a lot and how they handle situations differently. Could you explain more about this? A lot of sponsors, like I was saying, handle things very differently and having these expectations at a site who is running at the bare minimum of staff, because we had staff in and out of the office, we had to do remote, we had to flex. There was a lot of things happening and all we were trying to do at the end of the day was bring the care to the patients and no matter what that looks like.
And a lot of sponsors were still very much expecting the same level of communication, the same level of service that we had always provided specifically to them. The patients always came first. But we had a lot of sponsors asking, oh, can you go into portal x, y and z to do this, this and this? And we unfortunately, the site had to say not at this time.
We're being pulled in thousand different directions. Some of our team was pulled to do COVID studies and we needed to be able to prioritize both of these, you know, our oncology patients, as well as the COVID patients with the same number of staff and a lot of sponsors thought that by creating these different portals and different access points and different workflows and all of these different things that I would actually make of sites life easier. And I imagine that if a site had one sponsor with one study in more than likely did make their lives easier. But when I was saying, if you have 10 sponsors, 10 studies with 10 sponsors and unfortunately really doesn't make it easier trying to remember what 1 through 10 have specified what they want us to do during this time of absolute and utter chaos.
We really just wanted be able to send an email and just collaborate and figure this out together. We are the boots on the ground and we needed sites need to have a voice. And more times than not, sites feel that their voice is lost, and that was really prevalent during those first few months of the COVID pandemic were obviously still very much in the pandemic. But we've kind of taken our training wheels off and we've just gotten used to this new normal, which is obviously very unfortunate.
But those first few months, there were a lot of lessons learned very quick and swift from how we interact and how we interface with all of our different sponsors.
Looking forward, how do you see clinical trials changing in the next few years, especially after the pandemic? Looking forward in the next few years, I think nothing is going to get more simple. I think things are only going to get more complicated, which is both exciting and challenging and all of those great things.
But we also need to figure out how are we going to do all of those things, especially in this post. And again, I say post very lightly post-pandemic world, it's obviously like I was saying, still very much here, but we kind of just gotten used to it. How do we manage that? Obviously, for a lot of sites, there has been a.
Emerging of staff health care definitely saw a lot of things that people never thought they would see in their careers, so site retention has been a huge challenge kind of across the board. And that really has to play a factor in these clinical trials changing because like I was saying, you know, every study now has six or seven amendments. That's essentially like opening up six or seven new studies. But when sites have limited staff, how do we continue to do that?
How do we continue to enroll the way that we need to? How do we continue bringing the patient care that is so desperately needed and the clinical trial landscape over these next few years? There's a huge emphasis on cellular therapies, which are a huge burden on sites. While yes, being very cool technology and a great opportunity for patients and quite honestly, super exciting when you kind of come up for air for a minute at being at the site side and seeing what you're doing.
But they are incredibly complex and require so many ancillary departments to be able to actually do this study. And so it requires a huge amount of workforce at the site. On top of that, there's also, you know, a huge focus as they're really always has been on precision medicine. So a lot of studies are going into these specific mutations.
And these specific key areas. Are there any other
changes you've seen a lot of what a lot of sponsors are doing, and there has been FDA guidance on how to do. These types of studies are the master umbrella protocols. And so you have a master protocol and then four or five sub studies under that master protocol.
And again, it's one of those items that in theory, is an excellent opportunity for patients. A patient can enroll on onto that master protocol and be able to get a dozen different therapy options based off that one protocol. And you know, you can bring all of those to the site with just one study. However, from a site perspective, that is not just one study.
You have your master protocol, which is one study and then you have your 4.5 six, whatever that number is of your sub. Studies that all have different treatments, all have different schedules, all have different requirements for eligibility. And so that actually for the site is about four or five or whatever.
That number is different studies. And again, sites very much understand the unique benefit that provides patients. However, it is an incredible amount of work for the site because it is not just one study. It is, however, many of those sub protocols are.
That's actually how many studies it is for the site to be able to prep and operationalize. And all of these things are all going. They're all growing immensely, and I don't foresee those things stopping anytime soon in the near future of how they're going to evolve and change over the next few years. Obviously,
in this pandemic world, there's a lot of keeping things off paper because people are working from home.
And this remote lifestyle that a lot of people have the benefit of. And so that means a lot of different portals and different technologies. We recently and our site kind of did just a brief survey because we wanted to see how many portals are we actually being asked to use. And on average, every study had four to five portals.
Again, when you have one study, four to five portals, that doesn't seem like a ton, that's manageable. I can remember four or five passwords. However, when you tie-in the fact that most sites have upwards of 10 studies, you're now looking at 40 to 50 portals, you're looking at these huge number of portals. And that is a ton of work and remembering.
OK, so study one two three has a portal for IP addressing, but they also have a portal for these safety reports, and they also have a portal for the collection of our pros. And remembering all of these things while trying to enroll patients in record time is a lot. That sounds very intense now. Two of
our key values at tech are diversity and accessibility.
What is your view on how clinical trials are changing in this area? There's a huge emphasis right now as there should be of diversity enrollment on clinical trials, and that's going to change the landscape. And as it should because there is a huge need and there's going to be a push for how do we get clinical trials to sites that can benefit these communities? And how can we figure out ways of being able to get minorities on to clinical trials as quickly as possible and bring the care to them?
There's also going to be a stronger patient voice patients now and are being able to have say in their care they're more educated than ever. And these are all very empowering things, especially for patients to be able to have a say in how clinical trials are developed, where clinical trials should go. There's so many patient advocacy groups and like the same patients, are more educated than ever right now on clinical trials, and that is so exciting to see. At the end of the day, everything that we do is to benefit the patient, and now that they are getting a say in the care that can possibly be provided to them is just it's awesome.
It's great to
hear that sites are moving in that direction. Greater patient input and diversity. Do you have any final thoughts to add sites? Having a voice, I think, is starting to actually evolve and we're starting to have a voice and that is a very exciting thing to have happen now.
Sites are being part of the protocol development process and we're being sent protocols not just from a medical perspective of how well they work and can they work, but from an operational perspective, getting protocols and saying before their final and saying, can you look at this pKa schedule and see if you believe that sites can do this? That's a great conversation to have. Thank you so much, Chelsea, for joining me on the podcast today, and
that's your dose of totally clinical for all the listeners out there. You can follow her on Twitter.
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