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The Power of More: Re-imagining the Traditional Business Model for Oncology Clinical Research

Webinar for Research Institutions

About the Webinar

Rising costs. Shifting resources. Increasing pressures. “New Normal” virtual settings. Critical challenges provide ample opportunity to re-imagine the traditional business model for clinical research. Motivated clinical research leaders want increased focus on patient care, faster study starts, more patient access to trials and better performance – while reducing costs and staffing burdens.

Join us to hear from Franciscan Health as to how they have navigated the changes in the traditional business model and incorporated unique solutions to enhance efficiency while ensuring quality and compliance.

What You’ll Learn

During this 45-minute webinar, you’ll hear Franciscan’s case study and pick up key strategies to engage more clinical trial patients, access more studies, and maximize revenue.

We’ll also cover key topics, including:
• Differentiating your oncology clinical trials program
• Practical approaches to increase patient focus during clinical trials conduct
• Improving target study activation timelines

Webinar Transcript

Meg Troast:                    

Welcome everyone to today’s webinar, the Power of More: Re-imagining the Traditional Business Model for Oncology Clinical Research. I’m [Meg Troast], Vice President of Study Startup and Administration at WCG, and in my role, I have the privilege to develop solutions that solve administrative pain points for sites and institutions. I’m thrilled to see many of our site partners on this webinar.

Now a bit about WCG. WCG is the world’s leading provider of solutions that measurably improve the quality and efficacy of clinical research. Specifically for sites, we support many of the critical pieces along the clinical-trial life cycle, including ethical review, study startup, financial management, patient enrollment and engagement, as well as enterprise technologies. Our managed-research solutions were purpose built to serve the individuals on the front lines of science and medicine, and allow them to focus more time on patient care.

We have two speakers today. Kathleen Kioussopoulos, the Director of Research Administration at the Franciscan Alliance Research in Mishawaka, Indiana. The Franciscan Alliance operates 14 hospitals in communities in Illinois and Indiana under the Franciscan Health name. Ms. Kioussopoulos leads the organization’s research efforts across those 14 hospitals and associated physician practices. Her career has spanned both clinical nursing, cardiovascular research, program development, leadership, and site operations. Among her many accomplishments, she is also an active member of the Association of Clinical Research Professionals. Kathleen was a charter member of the Clinical Trial Best Practices Study Coordinator Advisory Committee from the Duke Clinical Research Institute.

We also have Sandy Smith, SVP of Clinical Solutions and Strategic Partnerships at WCG. Sandy is an oncology focused advanced practice nurse and health care leader who has held diverse roles in corporate and community-based practice and hospital settings. She has spent her career partnering with physicians and other healthcare stakeholders to drive customer value and clinical excellence in patient-centric oncology services.

Prior to WCG, she was the VP of US Oncology Research and Oncology Site Management Organization of Independent Practices, and hospital-based research programs. Sandy was responsible for developing strategic partnerships with sponsors and sites, to expand clinical trial services in early and late phase trials. And she launched a gene and cell therapy program. At WCG, Sandy works the sites to assess operational challenges, and strategically aligned clinical solutions to optimize their clinical trials processes. You can go to the next slide, Greg,

For the agenda today, we’ll begin by highlighting some trends in oncology and oncology clinical trials. We will then outline challenges that contribute to optimal clinical trial workflows, impeding many organizations research team’s ability to open more trials, enroll more patients, and drive profitability, in order to continue to reinvest and grow a research program. Our highlight we’ll be hearing from Kathy and how she and her team have re-imagined their research program at the Franciscan Health System and redefined their research business model to adapt to the evolving clinical trial landscape. For a bit of housekeeping, you can submit your questions via the chat feature, and we’ll also have a few polling questions during the presentation. This session is being recorded and the recording will be available post-webinar at this time. I’d like to turn it over to Sandy.

Sandy Smith:                   

Thank you, Meg and good afternoon, everyone. What an exciting time to be in cancer research, even though we’re only a few months into 2021, the year has already given rise to a number of events impacting our work in clinical trials, beyond mass vaccination. If you could advance to the next slide, please? 2021 marks the 50th anniversary of the National Cancer Act signed by then president Richard Nixon officially declaring the war on cancer. The act form the National Cancer Institute and among other accomplishments expanded the national clinical trials network. Over the past few decades, federal investment in cancer research has helped lead an almost 30% decline in cancer death rates. Unfortunately, not all individuals with cancer have benefited equitably from this success, as Blacks, patients living in rural areas, populations with lower income, and education levels, and others continue to experience lower survival, and higher mortality rates for many cancers.

On a positive note, over 1500 new cancer, drugs or indications have been approved by the US Food and Drug Administration since 2006. Your collective work has led to these accomplishments. And in recent news, just last Friday, the Biden administration proposed the creation of a $6.5 billion medical research agency aimed at curing cancer. If the agency is established, it could a fundamental shift in how the US government funds research steering the emphasis from basic science to higher risk projects, more directly aimed at major medical breakthroughs. Next slide.

As we all know, minorities are underrepresented in cancer research. While clinical trials tend to provide patients with the most innovative and sometimes the only treatment option, yet only an estimated 3% of adults with cancer participate in clinical trials. And with that, inequities exist in clinical trial enrollment while there are many contributing factors, payment parody has been an obstacle for individuals covered by Medicaid, which is approximately one fifth of the US population, representing nearly 68 million individuals, according to medicaid.gov. The Clinical Treatment Act, which was passed in late December, 2020 requires States to create Medicaid payment policies, to cover routine items and services such as the cost of physician visits or lab tests that are provided in connection with participation in clinical trials for serious and life-threatening conditions. The law includes a 2022 start date, and that’s January of 2022, for this coverage through Medicaid. Currently 15 States provide coverage, but this would bring parity among all 50 States.

I also wanted to mention these underrepresented groups, as health disparities and clinical trial diversity is something of great interest among sponsors. So if you are gathering information on the patient populations you serve, I think that will do well for you in the future, and if you don’t, it may be an area that you choose to begin to explore. Next slide, please?

I mentioned over 1500 cancer approvals since 2006. You can see from this graph that the pace of approval has accelerated in the past few years, both for new drugs, as well as for expanded uses. We’ve seen the complexity of trials increase, including study designs, basket trials, adaptive designs, and along with this, more administrative work, as it’s generating many, many more protocol amendments. Despite the disruptions caused by the pandemic, the FDA Center for Drug Evaluation and Research approved 53 novel therapeutics in 2020. This is the second highest total ever, falling just short of 2018’s all time high of 59. Next slide?

As we look at therapeutic areas, you can see from this five-year comparison that oncology has been, and remains a very strong therapeutic area. This year, we can expect to see trials continue in immunotherapy used alone, or in many multiple combinations, as well as an expansion of cellular and gene therapies. The boundaries for cancer research just continue to expand. Think about CRISPR and the gene editing opportunities, cancer vaccine trials, and then cellular therapies, for example, [inaudible]; over 50 trials initiated since December of 2015 and diffused B cell lymphoma, mantle cell, indolent non-Hodgkin’s lymphoma, multiple myeloma, sickle cell, the acute and chronic leukemias, as well as multiple solid tumors, including sarcoma, melanoma, non-small cell lung cancer, prostate, pancreatic glioblastoma, as well as biomarker driven basket trials. Some of the key ingredients to participate in these exciting trials in 2021, will be conducting molecular profiling and harmonization of these next gen sequencing reports. There’ll continue to be services in demand for clinical trials, as well as for personalized medicine.

The availability of liquid biopsies will hopefully make the burden on patients, less burdensome. Digital tracking devices, and continuing to optimize the use of telemedicine services in a recent report over half of the top disease indications were in oncology. So again, the pipeline is robust and lots of demand for sites for sponsors to place their trials. So prior to bringing in Kathy and learning more about her research program, I’d like to initiate the first of four polling questions, and this one is rather lengthy, so it will come to you in two parts. Can we initiate that first question? So what are the top issues impacting your site today, and please check off all of them that apply?

Craig:                                

So this is Craig, thank you, Sandy. We have our poll up, so make sure to check all that apply. There are two parts there, and so make you see the second part before you make your submission, and [inaudible] force you to make a selection. So if it doesn’t apply to you, click that N/A option before submitting. And I do see we’re going to number of responses in now.

Sandy Smith:                   

Thank you, Craig. And when those responses start to slow down, we’ll move into the second half.

Craig:                                

Okay, so I’ll go ahead and end this here. 3, 2, 1. And we’ll share the results. So we see we have both halves on the same [inaudible].

Sandy Smith:

So trial enrollment seems to be a major pain point. But clearly, lots of pain points, and we’ll be talking about some of them today. Great response, thank you to the 93 of you who responded. All right, with that, I’d like to invite Kathy to join us.

Kathleen Kiouss:         

Hi, Sandy.

Sandy Smith:                   

Hi, Kathy. Thank you so much for joining us today. As the Research Program Administrator for a multicenter research program, we’re delighted you can join us today. I know you’ve spent a lot of time and energy planning for changes pre-pandemic. Maybe some pivots had to occur as a result of the events of 2021, but would you tell us some of your experiences in managing, and re-imagining your multi-center research program, maybe focusing on some of your biggest challenges, and do they differ from two years ago, and some areas that you’ve been targeting for making efficiency improvements?

Kathleen Kiouss:         

Sure. And thank you for having me today, I really appreciate the opportunity. Franciscan Alliance and its associated hospitals and clinics, we have kind of a unique… We’re a community-based health system, right? And our location geographically is mostly in central Indiana, and Northern Indiana, and the South suburban Chicago area. And one thing that’s unique about our organization is, with us being a faith-based organization, our sisters who started the hospitals many, many years ago, took our hospitals to places that were underserved and underrepresented. So, listening to your initial slide deck, and listening to the questions about health disparities and populations that are underserved, I think, I can certainly appreciate that, from the system level here at Franciscan, as that’s a particular interest to us as an organization.

So in terms of our research program, we operate our oncology program as more of that hub and spoke model where you see in other. So our central hub of research for oncology is based in our Indianapolis campus, and our program there is a partner with the Alliance Group, and so we bring in our cooperative studies through that. And we’ve developed a distributed model for cancer research across our organization with that in mind. 2020, obviously for all of us in research had kind of a variety of effects. For us in particular, I was very much surprised to see the role and the evolution of our organization’s understanding of research, and how much it valued research, and how we actually became more integral to the clinical care that was being given, as a result of the pandemic. And when you look at some of the therapies early on being under emergency use, or especially in the very beginning, when it was under compassionate use. Immediately our system looked to the research staff to make these therapies available. One of the earliest things that I remember at least in this pandemic is, as a non-academic center, we’re not really maybe first in line for a lot of the trials that were being offered. And for us as an organization, I felt it was important for us to get involved early on in some of those COVID studies, which now there are hundreds of. But early on, it was quite competitive. And for us, I think having the relationship we’ve had with WCG and Western IRB allow for us to have access to a trial early on that then also helped bring that visibility of research forward in a health system that’s really more focused on community-based hospitals.

So two years ago, I would say the research department very much mirrored what the health system was doing. And at that time it’s a group of hospitals that were kind of loosely affiliated through a name. But becoming a health system and operating as a health system is a cultural shift that occurs in over time. And so we were able to take our research department and use our infrastructure within our health system to allow us to bring out some of those trials that I mentioned through cooperative studies and also some industry studies throughout the last couple of years. So some of our struggles, I would say, have been trying to establish a common infrastructure across a large health system can be challenging if you’ve had legacy departments or legacy staff in different parts of the organization that maybe were embedded in their historical methods.

So what we did as an organization is created a system-wide infrastructure with the office that I sit in, and we created those system-wide standards. For us as an organization we’ve chosen to partner with WCG for most of our IRB and IDC projects. And basically, it helps us. One of the things that that helps is it creates that common standard. And in a Catholic Health System we have specific requirements that are there that maybe other organizations don’t have. And for us, partnering with a large IRB has helped us create that. Our consent form looks the same, whether you’re in our Northern Indiana hospital or Western Indiana or Indianapolis. So that’s been helpful for us. The other thing that we’ve done in terms of trying to get some common infrastructure put in place is having a standard pricing model for research, making sure that we are adequately budgeting for our projects.

And what I’ve experienced over … and I’ve been doing research for over 20 years. What I’ve seen is a big shift. The administrative burdens that have been shifted over to the sites and the complexity of the trails as you mentioned, the trial design itself, the number of visits for the patients and all the different components. And then you layer on top of that, that the organizations and these community hospitals, we are tasked with the Medicare compliance associated with all of that, the billing compliance. And really, ethically we don’t want our patients to receive any harm financially from participating in research. We’re supposedly here to help them have access to these treatments. So part of what we’ve done as an organization to help offload some of that is for us to create that standard fee schedule, for example. Having a standard pricing model. Making sure that we apply the same requirements to all the different trials that we see. So part of, I guess … I don’t know, Sandy, if you had other components of that, if I touched on everything. I feel like I …

Sandy Smith:                   

Yeah. That was great. We’re going to drill down into a little bit more detail, I think, in the coming slides. Thank you, Kathy.

So certainly some of the things that you mentioned, standardization has become a big buzzword now. And I think we know that standardization provides predictability and visibility, should allow workflows to be established so that when you have multiple parts of organization, which is really the reality of working in clinical research, that the right and the left hands know what’s going on. Things that you mentioned, like your standard fee schedule, your use of a central IRB. And we’ll go into a lot more detail on those. If we could progress to the next slide, please.

So when I think about success factors in conducting clinical trials, three things come to my mind. One is rigorous study initiation or startup times. The second is meeting and exceeding enrollment. And the third, and this is what pharma pays us for, is quality and timely data entry. So I think before we go any further in talking about initiation and getting into some of these details about the pressure on sites, we have another polling question about study initiation. So if we could bring up that polling question. So this one has to do with your study startup timeline. And for this poll, we’re defining it as when the protocol is presented to your institution, to the point of trial activation.

Craig:                                

Thank you, Sandy. That poll is up and getting lots of responses coming in. So we’ll keep this open for a few more moments.

Sandy Smith:                   

Thank you.

Kathleen Kiouss:         

I don’t know, Sandy. This topic, I think has been one of the key kind of pain points for clinical research for a long time and continues to be one that I think we all struggle with. So it’ll be interesting to see what people comment.

Sandy Smith:                   

The Nirvana of getting below 30 days. Certainly something to strive for, but only 2% of those of you who responded are able to achieve that. Although I will say a number of you, 18% within that 31 to 60 day timeframe, and seeing some much longer. Clearly we know that there are studies that have been done that looked at a couple of elements related to study startups. So maybe Kathy, we can talk about some of those.

One factor that we know has an impact on study initiation is the workflow. Are the elements being done serially or in succession where one task has finished before another one or concurrently? And some of the studies have shown that if you put concurrent workflows in place, that that can reduce the time by up to a half. However, in some cases you may be working at risk and therefore if something falls short in the negotiations and you don’t move forward with that study, you’ve expended time and effort that’s really not going to be realized with conducting the trial. So I wonder if you can comment on your workflows?

Kathleen Kiouss:         

Yeah. Like I said, I think this topic has been central to the clinical trial enterprise for a long time, and it continues to be an issue. But what is fascinating to me and I think maybe others on the call is to see that when you have a motivated sponsor, when you have a situation like COVID, where suddenly all parties have a very vested interest to see a trial get up and running quickly. As a research enterprise across the US, we actually completed trials and got the vaccines out on the market and in a record time. And that was in large part due to site to enroll these patients. So for us as an organization typically, we do measure, we do try to keep track and get in within 30 days, that’s our target. But there’s so many pieces of that that are so outside of our control, but for us, we do things in parallel to whatever degree possible.

We want to make sure we’re at least fairly certain. We want to make sure we’re selected as a site for one thing. That’s a key thing is understanding if the site’s been selected. But like I said, we try to do things in parallel. The other partnerships that we have established, and this was many years ago, I think probably five or six years ago. We started utilizing the PFS services that WCG offers. And for us, it’s allowed us to have the ability to A, standardized the approach in a very consistent fashion. We are able to offload some of that administrative burden from my office. We don’t carry the staff costs to negotiate budgets and to do coverage analysis, for example. But if we need the surge capacity, so let’s say suddenly we have 15 studies we need to look at, we can send them off, get those done. And that work happens in parallel in a efficient way.

So for us, that’s been helpful. But the pain point of the back and forth, and I think you and I talked the other day, I think for us as a site, what we see or what I’ve experienced is sometimes there’s an interested third party, meaning sometimes if the CRO is involved, you deal with an additional sometimes delays that are outside of the site’s control. You could turn things around in 24 hours and wait to hear back because there was maybe a change in staff at the CRO or the sponsor. So it’s a tricky thing to really nail down what’s driving it, but it’s been a long, a long time pain point for a lot of sites, but again, we try to do whenever possible things in parallel.

Sandy Smith:                   

Yeah. And as we look at the number of items that are listed on this slide that contribute to startup delays, we certainly do have responsiveness of the sponsor CRO. Some things we can impact such as budget negotiations, contract negotiations, and others, we just need to work on improving the communication and workflows. I will say one other item related to study startup is the size of the study portfolio. And there has been some data shown that sites that are managing under 100 studies can be a little bit more nimble and might closely approximate those lower study startup times than very large institutions. And if they’re managing 300 plus trials, that too can be a big burden to continue to process, and that can lead to longer delays. But I’d say the target, if sites are looking to establish metrics should be somewhere between 30 to 45 days, ideally.

Kathleen Kiouss:         

So it looks like there’s a few questions in the question box, if that’s okay.

Meg Troast:

Yeah, Kathy. Let me kind of prompt those for you. This is Meg. The first one is how do you respond to sponsors who push back your standard fee schedule and standard requirements as sponsors are dealing with multiple sites across the country?

Kathleen Kiouss:         

That’s a really great question. And it does happen. I think one thing to really have a really good understanding of is fair market value and pricing. So how are you priced? What’s the basis for your price? And what’s the rationale for what your ask is? And if you understand that and you can give documentation that really supports your ask, I see that probably, I’m going to say maybe 80% of the time, you will get what you want. What the sponsor doesn’t want to have. And you don’t really, as an organization want to have it either is you don’t want to be that outlier, so the average site is costing them X and you’re twice that, or you’re somewhere out on the some end of the spectrum. Now you’d also don’t want to undersell.

That’s the thing. Like I said, we talked about the burden being shifted to the site. And I think one thing I’ve learned over time and in doing a lot of this is it’s important to get your costs covered and be sure that you’re adequately budgeted. So I think you will get push back and that’s okay, but as long as you can give proper documentation, and that’s where when you have a defined fee schedule and I explained to sponsors, “Look, here’s the basis for our price. It’s based on this metric. And it’s an item that everybody can look at as a standard. It’s publicly available.” So Medicare pricing as a basis or whatever your standard would be. So that’s how I respond to that. And sometimes it doesn’t work. And sometimes you have to decide is the item that you’re fighting about so to speak, worth it? Sometimes it is and sometimes it isn’t. Sometimes you can give a little bit on the price of, for example, of a CBC versus the price of a PET/CT.

Sandy Smith:                   

Yeah. Kathy and I think one thing that I have found in my experience that is often undervalued is time. Whether that’s the time on the part of the position of the CRC, the person that’s collecting the tissue or even the pharmacist time. So making sure that as you’re looking at those protocols, that you are considering all the time for the multiple professionals that will be contributing to that study. I’d like to do another polling question now, and this one has to do with the coverage analysis and budgets. So, does your site itemize fees in your trial budget for creating the budget, negotiating the budget, and conducting a coverage analysis?

Kathleen Kiouss:         

This is a good question. I’m interested to see what people’s reaction is to it.

Speaker 1:                       

I think we got most of our responses ongoing in this polling, sharing the results.

Sandy Smith:                   

So 68% [crosstalk] including it?

Kathleen Kiouss:         

Yes. That’s so important. The way trials are budgeted, typically there’s appropriation amount. Just because you’re given appropriation amount doesn’t mean that you shouldn’t itemize on your end as an internal discussion. So you should have a very systematic way with which you are as an organization’s going to take that money and divide it across whatever expenses you’re attributing to it. So having that work done on that, in what I call an internal budget, it’s really important from a compliance standard, I think.

Sandy Smith:                   

I agree. The coverage analysis will not only provide insight into the true cost of your clinical trial, but it’s also going to guide your billing compliance. And again, as you’re looking to benchmark your own staff internally, or possibly an external partner, if that turnaround is more than about seven days, that’s just adding to your overall study startup process. I think also related to budget preparation and valuing of time, as we’ve moved more into a remote monitoring environment, has that been easier on your staff, Kathy?

Kathleen Kiouss…:         

Well, if you ask my staff, I think, again, the work has shifted. What’s required to host someone on site versus what’s been required of us to allow someone to have access to our health record, there’s a lot to it. There’s a lot more to it than just sending a link out there that someone can access via the web. We, as a healthcare industry are targets of different cyber attacks and things. And we do care deeply that our patient’s PHI is protected. So to send a web link out to a monitor sitting wherever they sit, it’s been interesting to see because we’re asking them to provide us with some details. We asked for the date of birth and their last for their social. And why are you asking for that? Well, you ask us for a lot of things. And if you want access to see our patient records, these are some things that we are required to ask. So it’s been a little more work, I would say, on our staff to do the remote monitoring.

Sandy Smith:                   

[crosstalk] And then valuing your staff’s time, whether it’s onsite or whether it is remote, having good estimates of what that time allotment will be, so that, that too can be itemized in your budget. And I will say, I loved your comment before about having a fee schedule, but then also taking into consideration inflation. So not too long ago, I worked with closing down a 15 year study. That was a survival study. And as we reflected back at what research looked like 15 years ago, paper forms were being faxed. None of the automation was there. And so unless you are putting some kind of an inflation factor into your budgets, particularly for longer term studies, you may find that new expenses may pop up that you can certainly approach by an amendment, but being able to account for some inflationary factor is a good idea.

And so the budget negotiation includes not only the turnaround time, which we were talking about as part of that trial startup process, but then also achieving your budget negotiation goals. And again, if you don’t ask for it, no one’s going to really offer it to you. Okay. How about contract negotiation, Kathy? Certainly this has changed in recent years. You referenced cyber security years ago. Having cybersecurity insurance was not part of any clinical trial agreement. What are some of the things that you’re seeing language-wise that are now appearing in agreements that maybe weren’t part of the CTA in years past?

Kathleen Kiouss…:         

I think some of the European requirements that are coming through, some of the EU new requirements are coming across in contracts. So we’re being asked to have foreign [inaudible] be a part of our contract, which I think is hard to imagine why we would agree to that. The thing that surprises me, I think there is a question about subject injury. And it was a few years ago, I used to fight on every contract about subject injury. And that seems to have died down for whatever reason. Indemnification is still important. And we still sometimes have to push back a little bit on certain trials to be sure that that’s there. Again, it’s protection of the organization, but it’s also protection of the patient. In the contracts, I guess, the other big area… For me, one of the biggest things, it’s a pain point for sites is this concept of hold back in terms of budget.

So the whole back of a percentage of your budget and what other model is out there in terms of a business that would operate off of, “Oh, you’re going to hold back 10% or 15%.”? That is a negotiation I do try to push to get that either removed or reduced. That’s one thing. The other big thing in the contract that I think is sometimes a pain point is term and termination, being able to terminate the trial if you need as a site to be able to potentially terminate the trial for certain things. A lot of the agreements are very one-sided. So for example, PHI, the sponsor should be able to say that they’re going to hold our information confidential as much as we hold their information confidential.

So some of that bilateral language is where we see some pushback. So if I try to change the wording to make it bilateral, meaning both sides have to agree to it. It’s interesting to see the pushback, but things that I used to fight about are less common now, especially, I think there was a question about subject injury. But sponsors seem to have gotten it that they can’t ask us to bill Medicare first.

Sandy Smith:                   

And it was the collective [crosstalk] sites, right, that led to that?

Kathleen Kiouss:         

Yeah. Because [crosstalk] we own the [inaudible].

Sandy Smith:                   

I think one other comment I’ll make about budget development, unless the right people are preparing it, and to your point, including all of the costs for the trial, what you may find is you are awarded the trial and as soon as you get it open, you realize that something has not been done well. And then you begin doing amendments. And certainly doing amendments on contracts and budgets just consumes internal staff time, oftentimes delays payment. And just becomes very, very complicated in terms of not being able to bill until your budget amendment has been approved.

So trying to get that done, well, at the beginning of a trial, will just allow for a much smoother execution. So those are the top two start-up delays that were listed on this graph on the survey that was done by WCG center watch. Let’s now shift gears a little bit to enrollment. Some staggering statistics, 25% of cancer trials fail to enroll a sufficient number of patients and 18% of trials close with less than half of the target number of participants after three or more years. So we do have this challenge. And in fact, in our initial survey, enrollment was identified as a pain point. So Kathy, maybe you can tell us a little bit about your experiences with study enrollment.

Kathleen Kiouss…:         

It’s important when you’re in the negotiation phase and when you’re considering the trials, understand your patient population and how well do you know the protocol and how well do know your population? And so it’s a challenge. So we see hundreds of patients a day in the clinic and how do we know which patients have which disease? Or is it the right trial for us? So doing some homework upfront in terms of looking at your patient population, in terms of disease process and statistics, in terms of maybe looking at your analytic cases and understanding exactly what you treat and how you treat. We work a lot with our pharmacists to be sure that whatever studies we’re bringing in don’t conflict with, maybe you have a hospital standard date you follow that your practice uses.

So one of the things that we’ve done recently is we’ve partnered with a company. It’s a startup company, but we are looking at… You had brought up the question about molecular testing, or you were talking about that in matching patients. Our molecular testing, interestingly enough, the way it comes back into our health record is through like a PDF. So it’s not a discrete field in Epic. And we have partnered with a company that’s looking at using natural language processing and AI to pull out some of those molecular markers to see if we have the patient population. And so it’s really been helpful for us to identify to say, “Do we really have patients with that mutation or do we just think we do?” And so getting those real numbers to help us discern if that trial is really going to fit with what we see, for us, it’s under a pilot right now, but it’s something that we’re looking to do more of with Epic.

Sandy Smith:                   

Great point. Between the feasibility and that budget review, the coverage analysis really should give enough information to a site to determine is this the right trial? And sometimes the patient population is there, or the science is really exciting for the investigators. And at least you’re moving forward knowing that there may be some risk associated with certain trials. Some of the other things that I’ve seen from an enrollment standpoint that can impact enrollment is when you’re dependent on referrals from a particular surgical specialty, sometimes those referral sources change. Someone moves out of town and you’ve taken on a trial with an assumption that the referrals would come from a particular source and then it’s no longer there. You’ve mentioned using technology, clearly there are a lot of solutions that are being touted on the marketplace as to helping with enrollment. And I’m not sure that we’ve identified anyone that is the absolute best, but certainly a lot of people are trying very hard to find that magic bullet.

And I think the other piece is looking back at past performance on similar trials. You mentioned looking at competing trials, but also were you able to be successful previously with a similar trial? And hopefully if you weren’t, the group did look at the reasons why to know that this is what occurred so history would not repeat itself. But I will say, if you have poor enrollment with a sponsor, that is something that’s very difficult for them to forget. So when possible doing your feasibility to not only meet the target that you’re putting forward, but you’re going to have raving [inaudible] if you can exceed it.

And then the last item that’s been referenced in the literature multiple times is there is a correlation with the time that it takes to enroll the first patient. And I’ve seen anywhere from 60 to 70 days from trial activation. So when you’ve opened a study, if you’re able to get that first patient enrolled, that it really is an indicator that you will be successful in your enrollment. Kathy, what’s been your experience with the time to first enrollments?

Kathleen Kiouss…:         

I think that’s a really valid point. And I agree with that. I think that if you’re not able to find a patient within those first 60 days, ideally, prior to even starting the trial, you would have at least some concept of some patients that would be… If you had the trial there today, we would have these patients beyond study. I think making sure that your physicians are aware of the trial getting close to being opening. And I think what’s hard is if you don’t have that date, don’t have that timing of knowing exactly when that trial is going to be open or if it gets delayed. I think that’s where people lose the enthusiasm. From the time we start considering the trial and you have an investigator or a group of physicians who were all excited, and then it drops to the bottom of the list. And so how do you put it in front of them? And again, in a way that they’re thinking about it when they’re seeing the patients. We haven’t leveraged Epic in that way yet. There’s some capabilities within the Epic research module that will allow you to do advisories, for example, like if there’s a patient who meets a certain criteria. We haven’t implemented that aspect of it, but we have used some of the other functionality within Epic, as far as messaging and tagging patients for a potential interest in trials. I’d be interested to hear if other sites have used that functionality, but for us, we’re still developing it, but we are trying to leverage every piece of technology that we have to keep us from digging through Excel workbooks and sending documents around that maybe get lost in email.

Sandy Smith:                   

As I mentioned earlier, the end work product for what we do in clinical trials is the data that’s supplied to the sponsor. I would like to talk more about staffing, so I’ll just briefly mention from a data entry standpoint, I would caution sites to not only be aware of what your standard operating procedures call for in terms of data entry times, but also what’s in your clinical trial agreements, because that clinical trial agreement will be what you’re measured to. And again, being able to meet those timelines, have less of a burden of queries will only hold you in better standing with sponsors.

And we talked about IRB. Clearly, as we look at IRB turnaround times, using a central IRB, as many sponsors are submitting their trial upfront, as sites are added, it becomes an expedited review and those reviews can generally be done in about eight to 10 days, so very quick. Clearly, there are some sites that still have second reviews done locally. That could be a contributor to your startup times, or if it’s solely with a local IRB, I’ll just encourage you to measure those turnaround times and then what impact that it has on overall study startup.

Okay. With that, we’ll move to the next slide and our fourth and final polling question, and this has to do with staffing. For those of you who filled out our pre-survey question, staffing came up quite a bit. What strategies or resources does your site use to flex up staffing for periods of high enrollment or during staffing changes? And as we’re waiting for that to close, I’ll just say reading a headline this morning, talking about some of the challenges that hospitals and institutions are facing with lower patient volume, canceled elective procedures, screening procedures, have certainly plummeted. Then the higher expenses to the pandemic have really created a crunch from a cash standpoint for hospitals. And we’re seeing some of that impact then on staffing with furloughs, delays in capital projects, pay cuts, and so forth, early retirements.

 Okay, here’s the results. Some having a very small number in in-house temporary staffing pool. Over time can only go so far, I think, before you burn out your team members. Adding new positions. It’s great if you can. We’re hearing from sites that that’s not always an option. Accessing external resources used by some, and then just none, we have a fixed number of staff. Kathy, what’s your response to this poll?

Kathleen Kiouss…:         

Yeah, I was going to say that would have been my answer. I think it takes time to find really good qualified people and they’re such a valuable resource. I think that you’re only as good as your weakest study coordinator. And so to keep a good qualified coordinator in the clinical research setting is challenging. Which is why I think we have to be mindful, as you take on the number of trials, it’s not about quantity, it’s about quality and it’s about making sure that you give people the opportunity to do that data entry.

If you have, and I’m sure anybody on this call is probably saying yeah, the physicians think that once you’ve signed the consent and you’ve done the enrollment that, well, let’s just keep going. Well, there’s a lot of work that goes along with that. And so making sure that you keep the cadence correct for that enrollment, not just to say, I need to be the top 10. I need to be in the top 10 sites. Well, no, I need to be a good site that gives good data, consistent and that you’re managing that balance between enrollment and quality and being able to catch up and not [crosstalk] your staff.

Sandy Smith:                   

I think ideally sites are challenged. So oftentimes they do run lean. But in looking at the ideal world, if you were able to increase your capacity by five to 10%, so if you get a trial that all of a sudden just really takes off, being to have some type of staffing strategy for how to be able to continue to provide those life-saving therapies or potentially life-saving therapies to patients, but yet deal with the additional burden that that places on the site.

So in this word cloud, try to capture many elements that influence an organization’s ability to be nimble with opening new trials. It is remarkable that when we look at trial opening and some of the influences with it, not a lot has really changed in the past eight to 10 years. Certainly, technology has become more prominent in our sites. And so Kathy, in the last couple of minutes, if you would address maybe what types of technology that you use and what changes that you’ve seen in the last few years.

Kathleen Kiouss…:         

Yeah, so the biggest technology component that we’ve implemented in the last two years has been using leveraging our Epic research module. We also have a… SignalPath is our CTMS program that we’ve been implementing. So we’ve been on CTMS programs for quite some time, so that’s important.

Sandy Smith:                   

How about electronic consenting? Has that become part of your routine workflows?

Kathleen Kiouss…:         

Yeah, so we have, through the COVID studies, been using some electronic consenting. But that creates its own set of challenges in terms of how we stay up on the versions, and I think we’ve had some issues with that. But yeah, we have used the electronic consenting. And I think I lost video some point here.

Sandy Smith:                   

But we can hear you, thankfully.

Kathleen Kiouss…:         

Okay. Okay, which is fine. But yeah, we have seen some electronic consenting, especially in the setting of COVID.

Sandy Smith:                   

So Kathy you’ve mentioned partnerships a couple of times during your presentation today, how have strategic partnerships played a role in your site’s evolution?

Kathleen Kiouss…:         

Yeah, I think finding those partners that will help you optimize your operations. And I did mention our relationship with WIRB has… Our organization’s been partnered with WIRB for many, many years, and having those standards embedded in the process with them has been extremely helpful. And then we have partnered with PSS as I mentioned, and that helps us. So I don’t have to get bogged down in looking at the minutia, if you will, in the coverage analysis. And I can’t keep up with all the standards of… The oncology trials being as complex as they are, it would just be impossible, for me at least, to keep up on all that. But having that standard that is followed, we set the standards and our partners help us implement those standards, raising the visibility for research across the organization, having a good institutional buy-in in terms of our leadership groups and making sure that we provide a consistent product to the sponsor. When they come to our site they should expect rapid turnaround as far as we can have it be. And I think by having some of those partnerships that we’ve established, I think has helped that.

Sandy Smith:                   

Well, Kathy, we appreciate at WCG the partnership that we share with the Franciscan Health Alliance, both for the ethical review, as well as the financial expertise in clinical research, we can move to the next slide. Just to sum up a couple of attributes for successful sites. Certainly, we talked a lot about knowing your organization’s true costs, doing a complete budget development and coverage analysis is essential, knowing that you have a fee schedule and updating that regularly. And if a trial is not financially feasible, making that decision, again, knowing the risk for your organization. Having a plan staffing strategy, inadequate staffing really does place your program at risk. So looking at staff augmentation availability for all positions, permitting your team to focus on patients, whether it’s the finance team, whether it’s CRCs data entry or regulatory. And again, WCG is in a position to partner with sites in staff augmentation and the study startup process, measuring and monitoring those elements that contribute to study startup and anticipating the potential obstacles.

So next slide. Are you ready to re-imagine your research program? Many organizational leaders are thinking about the upheaval of 2020, but acknowledging the successes that occurred. So what’s next? Resetting recalibrating, embracing change, ask why you’re doing things the way you’ve been doing them. Is there a better way? Look at those value added services, who does them? Can they be done better or more quickly and an alternate delivery model? Explore options to re-imagine ways to accomplish the same work with the result of allowing you and your team more time with your patients, the ability to enroll more patients and open more trials. So with that, I thank everyone for attending. Meg, we may have time for one question. Are there any questions in the queue?

Meg Troast:

There are lots, Sandy, so thank you to Kathy and Sandy. What we’ll be doing is compiling those questions. We’ll be answering them in the next few days and sending out an FAQ. So I didn’t want to interrupt the great conversation, but we do have a number of questions that I think will be great for follow-up and we’ll be sure to get those answers over to you as well as the recording, if you would like to share it. But again, thanks, Sandy and Kathy, it was great conversation and everybody have a great day. Thanks everybody. Take care. Thank you.