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10/27/2023

Q&A: Grow your clinical trial portfolio and increase enrollment with the TIME clinical trial network

Jason Claes, Clinical Research Manager at TriHealth, shares his perspective on optimizing TIME to increase clinical trial enrollment.
Authors Meghan Degele
Senior Director, TIME, Tempus




Jason Claes, MBA, MSM, GRCRA
Clinical Research Manager, TriHealth

TriHealth is a health system based in Cincinnati, OH, spanning four general hospitals, two emergency medical centers, and a rehabilitation hospital. The TriHealth Cancer Institute is the largest personalized medicine program for adults in the region.

Meghan Degele, Senior Director, TIME, recently sat down with Jason Claes, MBA, MSM, GRCRA, to discuss how he maximizes the impact of the TIME program to improve and grow his entire clinical trial portfolio at TriHealth. TIME is a just-in-time trial network that leverages data, technology, and a network of site partners to accelerate patient enrollment and open trials in an average of 10 business days. Read on to learn more.

Responses have been edited for clarity and length.

 

Meghan Degele: Could you please share what challenges you were facing at TriHealth that brought you to look at the TIME program as a solution to enhance your clinical trial portfolio and processes?

Jason Claes: Our partnership with TIME started two years ago when we had just lost an opportunity for a huge prostate study, caused by the nine months it took to navigate processes within our system to secure all the approvals and signatures needed to open the new trial. Our Medical Director said this can’t happen again, and that’s why we turned to TIME. TIME is fundamentally different because it does two things:

  1. It helps streamline the approval process with already approved contract language and a budget, and there is a review process to ensure that we, as the institution, approve. Overall, this cut down our time to activate a new trial by 94%.
  2. TIME automatically reviews a patient’s sequencing 1 and clinical history against a trial’s inclusion/exclusion criteria, which keeps patients who are eligible for a trial on the radar of our providers. This creates a conversation catalyst and a targeted evaluation of whether we take on a particular study, as we already have a population of patients who could benefit.

In contrast, in my experience with other institutions, you start from ground zero every time we look at a new study opportunity. We examine the study protocol, drill down into the details, switch over to our EMR system for an initial data mine, discuss, and come back to the EMR for additional data mining. TIME helped us eliminate the first vetting within the EMR system. We already know the base potential population who could benefit from the trial.

1. NGS sequencing with Tempus is not required for the TIME program


Meghan Degele: TIME was designed to help match the right patients to the right trials at the right time. What impact has TIME had on your overall clinical trial portfolio enrollment?

 

Jason Claes: Enrollment in my total clinical trial portfolio has grown from 2% to 17.5% in this recent fiscal year, with 37% of total enrollment attributed to trials that are in the TIME network. Three factors allowed us to achieve this 9x growth:

  1. TIME diminished the effort associated with startup. At the start of any new study, my teams are excited and ready to go. In a traditional study, two months, three months, four months pass while the study goes through all the paperwork to activate. When it finally opens in month nine, no one remembers the study anymore, or priorities have changed. So now all of a sudden, we have to rework everything to open up another study, putting the original study to the side. TIME has enabled us to significantly diminish this inefficiency, rapidly opening a trial so we can leverage the initial focus and excitement.
  2. TIME is constantly screening and surfacing patients who are eligible for trials that are in the portfolio. We can dive in further and say, “yes, we can support the study.” This helps us ensure we are activating trials where we have a population of patients who can enroll and benefit from the clinical trial opportunity.
  3. The quality of trials that we activate has vastly improved, due to the types of trials we have access to activate that are a part of the TIME portfolio. TIME has really identified trials that are new and innovative, that can be outside the scope of the general NCI trials as an example. I believe a really big factor contributing to how we are able to enroll better is that now my providers are excited about something brand new, or a novel option to provide to our patients.


Meghan Degele: Clinical trials also come with a financial impact. What ROI impact has TIME had on your trial portfolio?

 

Jason Claes:There is a financial impact to bringing a protocol live. I have an economics and finance background, I ran several clinical divisions, and I’m all about breaking even. That’s the first thing that I noticed with Tempus TIME trials. The program is actually looking out for us as a site to be able to financially cover our costs to bring a particular protocol to our patients.

As an example, collecting vitals or collecting a liquid biopsy — it could be one in the same. But, I look at what is the true labor cost of each activity? What does it cost my CRC in time, and I equate that into dollars. Now looking at the whole picture, I don’t just look at screening cycle day one. I evaluate a trial from the perspective of the cost if a patient goes through the entire study, and ask if the study is going to cover the cost of my scan in three years because of inflation. With TIME, we are able to say this study is very favorable for us to take on, or at least allows us to break even. So knowing this, I don’t have to worry about the financial feasibility of a TIME trial, or put as much effort into the financial factors compared to a trial that is not a part of TIME.


Meghan Degele: The TIME team works very closely with the sites that are a part of the TIME network. How has this engagement helped you with your program goals?

 

Jason Claes:TIME provides us with great customer service. For example, I’ve said to your team that we are very interested in a particular trial and are considering opening it up; however, we need some slides to be able to talk about this trial internally. Then, all of a sudden, I get these timely slides that can speak about the trial from a provider’s perspective, answering the question what does the trial specifically do for the patient, which is a critical piece of the conversation that our providers are asking. The customer service that TIME gives allows us to capture and maintain excitement and momentum with our providers and research team in regards to trials that are in our portfolio.

Meghan Degele: As we wrap up, what advice do you have for any new sites that are joining the TIME network?

Jason Claes:Two things come to mind that have had the biggest impact:

  1. There is a focus on a streamlined contract. I am so happy we have that agreement going across every single study. This saves me a lot of time because it is already pre-negotiated.
  2. The TIME Clinical Research Coordinator (CRC) program is incredibly helpful. We’re now bringing in our second TIME CRC. This CRC resource, paid for by TriHealth, focuses on Tempus TIME Trials, and alleviates the burden on my staff when monitoring and enrolling for trials in the TIME program. The CRC program has been very much appreciated and a godsend in building our TIME program.

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