ERT’s Vice President of Trial Oversight, Chief Diversity Officer, and Trial Better podcast host, Otis Johnson, is joined by Jennifer Stacey, Senior Vice President of Clinical Science and Operations at TriNetX for a conversation on real world evidence. They discuss how the non-global nature of real world evidence is changing for the better, and what that means for clinical research going forward.

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Tell the audience a little bit about yourself.

I’m currently at TriNetX as the Senior Vice President of Clinical Science and Operations, but I’ve been in the clinical and life sciences industry for 22 years. Throughout my experience, I realized a big piece missing in using data to better clinical research was patient-level data. About five and a half years ago, TriNetX came to me and I realized this was a new company up to great things, including using data to advance clinical trial research and planning.


For our audience members who aren’t familiar with TriNetX, can you share a little bit about the organization and what role it plays in the clinical research ecosystem?

TriNetX was founded in 2013 and commercially launched in early 2016. We are a global health research network and SaaS, on-demand patient data platform that includes advanced analytics and downloadable data sets. We connect the life sciences industry to patient data around the world and provide rapid insight generation to clinical and medical publications to advance thought leadership. We like to tell our customers, “Welcome to the revolution” – our mission is to help conduct trials that are faster and more efficient, so we can bring drugs to market faster and treat patients more quickly than they would have been otherwise.


Looking back three to five years ago, there was some criticism of the non-global nature of real world evidence. Has TriNetX responded to these concerns and, if so, can you tell us how?

It’s amazing how far we’ve come. Five years ago, TriNetX only had US data, but we knew early on that this wasn’t going to be enough. So, we set our sights on expanding outside the US, first targeting the EU, then the Asia-Pacific region and Latin America. This expansion, with the goal of building a network of data that is truly global, is very important to TriNetX.


I’m sure capturing this data at a global scale comes with complications. Have you faced any challenges throughout this expansion?

It hasn’t been an easy task to expand. The biggest challenge is how to get global data quickly. Our strategy has included organic growth of our network of sites outside the US, followed by inorganic growth through acquisition of Custodix, the “TriNetX of Europe,” in 2018. Over time, we’ve continued to expand our global footprint in every way; not just through our network, but through our employees, too. We’ve found it’s important to have boots on the ground around the world.


Have you seen sponsor motivation to use real world data change over the last few years in response to changes like capturing more global data?

We’re getting more and more requests for data outside the US on a daily basis. It’s still hard to come by this data, but there’s a high demand for global data that allows sponsors to optimize trials for patients, sites and PIs, or generate real world evidence of how drugs are being used in different countries.


How can real world data help the industry address ongoing issues with representation of diverse patient populations in clinical research?

Over the last few months, TriNetX has put an exceptional focus on diversity and inclusion in data. We believe real world data can provide a better understanding of all patient populations across various stratifications including age distribution, race and ethnicity, comorbidity, geography, and more. Sponsors can use real world data to expand their trials and pick sites that have more diverse populations of interest that would still be eligible for the study. They can also explore populations that may not be studied in randomized clinical trials, and how they’re using drugs and reacting to treatments in the real world. Having all this data and a large number of patients in observational studies is helpful for both trial optimization and trial design.


According to ERT research, as of last July, 82% of sponsors had adopted some type of virtual trial technologies into their studies. Does TriNetX have a role to play in helping sponsors run effective virtual or hybrid trials?

Yes! We’re heavily engaged with many sponsors to address the expanded demand for virtual and decentralized trials. We can work with healthcare organizations to do virtual and hybrid trials, but also use our data to help clients with external control arms, retrospective and prospective observational studies, parallel arms, and dynamic cohort studies (examining the incidence of a condition within patient populations.) These efforts can happen alongside randomized clinical trials, but demonstrate other ways of conducting studies that don’t involve enrolling patients in the old-fashioned way.


Do you have any final thoughts you’d like to share with our audience?

I think we’re progressing well as an industry in terms of recognizing the power of real world data and what it can do. I encourage everybody listening to do what they can to unlock more real world data and make it usable for our industry. Regulators are now accepting more real world evidence submissions and providing more guidelines on how to do it appropriately. From patients and healthcare organizations, we need more access to data, given it’s all provided with consent and in a de-identified manner. If we, as patients, all allow our data to be used, it’ll allow for bigger research populations, make studies less costly compared to RCTs, and ultimately help reduce drug costs. Using more and more data in research whenever possible is the most ethically sound way to keep moving drug development forward.


Coming Soon!


Jennifer Stacey
Senior Vice President of Clinical Science and Operations at TriNetX

Jennifer Stacey has 20 years of clinical research experience ranging from biomarker and target discovery to strategic conduction of drug development programs. By leveraging big data with health analytics and informatics, she has provided consultative trial planning, competitive intelligence, and custom project work for over 100 pharmaceutical and contract research organizations. Prior to joining TriNetX, Jennifer held scientific positions at Cell Signaling Technology, Citeline, and inVentiv Health. She received her BS in Biology/Pre-Medicine from St. Lawrence University.


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Watch the TriNetX webinar, “Closing Gaps in Patient Diversity Within Clinical Trials Using Real-World Data”


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