Andy Studna

In an interview at the 2023 DPHARM conference with ACT editor, Andy Studna, Amy Cramer, steering committee board co-chair, HL7 FHIR Accelerator Vulcan gives an overview of Vulcan and how it is working with the global research community to solve challenges in clinical trials.

Vulcan is a Health Level 7 (HL7) FHIR which is a type of standard: fast healthcare interoperability resources accelerator dedicated to both translational and clinical research. What really excites me about Vulcan is the makeup of the members of Vulcan. it is intended to include the research community: patient advocacy groups, large vendors to small individual people in their garage working, academic sites, small sites, pharma, EHR vendors; it's meant to bring everybody together to work on these problems and by doing that what we do is we don't wind up creating a solution that creates a bottleneck somewhere else and also my hope is that we're starting to allow for adoption of the solution because we built it together as a group. There's a lot of really amazing projects that are coming out of Vulcan. We have already moved forward with several implementation guides that are now standards. One that really has been resonating and getting a lot of exposure is the Gravitate Health e-labeling implementation guide and that's getting not only traction within Europe where that project originated but across the entire globe. I think that really set us up as an organization to be ready to handle those types of global projects because we are a global industry and so we are very excited that the ICH is asking Vulcan to convene the technical specifications for the protocol digitization and there will be other parties that will obviously be a part of that, CDISC included. And that's really exciting. I love that opportunity to convene the different groups of people together so that we come up with a solution that we can all adopt and move forward. And let's be honest, protocol digitization, that's a game changer.

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Amy Cramer, steering committee board co-chair, HL7 FHIR Accelerator Vulcan, gives an overview of Vulcan at the 2023 DPHARM conference in Boston, MA.

DPHARM 2023: Vulcan FHIR Accelerator

In an interview at the 2023 DPHARM conference with ACT editor, Andy Studna, Amy Cramer, steering committee board co-chair, HL7 FHIR Accelerator Vulcan discusses what she is seeing with the use of data in clinical trials including how to balance collecting too much data and the "right" data.

 Interoperability has always been a passion of mine since the day that my binders fell apart on the floor as a clinical research coordinator and I said, “Oh my gosh there has to be a better way to do this than writing on paper.” Probably dating myself. But what I'm seeing is that we're looking not just at interoperability now but we’re looking at what data are we collecting and why? And so that's a really difficult question to ask because at some sides of the coin, yeah you don't want to collect more data than is necessary. Right? That makes sense. That's pragmatic. But at the other side of the coin you want to make sure that you're collecting the data that you're going to need in order to be able to evaluate and so how do you balance these two so that you don't collect more, but you have the right data in order to be able to move forward and that's a real big focus that I think a lot of people are leaning towards. it will really help with interoperability; we'll be reducing the amount of data that we have to move, but I think that's an interesting space.

Cramer also spoke on Vulcan and its HL7 FHIR Accelerator, which can be found 

Amy Cramer, steering committee board co-chair, HL7 FHIR Accelerator Vulcan, shares what she is currently seeing in the data space of clinical trials at the 2023 DPHARM conference in Boston, MA.

DPHARM 2023: Current State of Data Usage in Clinical Trials

In a breakout session at DPHARM 2023, Melissa Easy, VP and GM, Clinical Technologies, IQVIA discussed evolving technologies in clinical trials and how they are being utilized. “We’re very good at throwing products at people, but we’re not actually very good at sitting there and thinking about: what is the site going to do? What is the journey we’re asking the site to go on? It doesn’t make any sense,” Easy said about the industry.

While COVID-19 sparked innovation and prompted the evolution of more clinical trial solutions, it created more choices for industry to make. Easy recalls hearing about a site that was given 22 different systems to consider.

“When I think about clinical trials and patients, they have a very different experience with technology in a clinical trial compared to what they do in their day-to-day lives and I think we need to change that,” Easy said.

Between patient centricity, different types of data collection, personalized medicines, and many other factors, the technology involved needs to come together and be cohesive. How can industry achieve that?

While it seems like a simple solution, it is not. However, Easy believes there is great opportunity. Industry needs to reconsider how it brings together all the different types of data from the different systems available, as well as finding a way to make these systems interoperable. “It’s going back to that concept of the journey, and I think it has to also start with not only outcomes, but the data and how it flows.”

Easy believes we are capturing more data in studies than ever before. She referenced a study from Tufts that found industry is capturing 3.6 million data points per study which is three times more than it was capturing 10 years ago.

The key is providing more intelligence on how to use the technology that brings all these data points together. “You need people who understand the technology and the subject matter expertise to really come together to do this, otherwise you risk doing lots of great data analysis,” Easy said.

New Tools for Clinical Development: Hype vs What’s Really Working Today? September 22, 2023. DPHARM 2023, Boston.

How can industry bring its latest technologies together?

DPHARM 2023: New Tools for Clinical Development

In an interview at the 2023 DPHARM conference with ACT editor, Andy Studna, Colleen Hoke, co-founder and CEO, ObjectiveHealth, discusses potential advancements in patient recruitment such as increased accessibility.

There will be tremendous leapfrog advancements. I think in five years patients who want to be in a clinical trial will be able to access it in some way; probably mobile enabled. I think in five years the vast majority of healthcare will turn into a research engine, so as patients come towards regular healthcare visits there'll be more and more options for them to participate and it really will be awesome.

Hoke also presented in a DPHARM session on ObjectiveHealth’s solutions. Along with Josh O’Rourke, chief technology officer of ObjectiveHealth, the duo explored a real-world case study demonstrating the combined impact of the enrollment solutions: ObjectiveScreen and ObjectiveView.

ObjectiveScreen is the company’s artificial intelligence-recruitment tool. Rather than working off of social media or online campaigns, it is embedded into coordinators’ workflows at the company’s sites. It syncs with the electronic health care systems and uses machine learning to identify candidates as they are visiting the practice.

As a result, the solution enables patients to be identified “on-the-fly” as they come into the practice.

ObjectiveView is designed for sponsors. It works hand-in-hand with ObjectiveScreen to offer a real-time view into the total eligible recruitment funnel for all enrollment activities. Sponsors are given full access to the data, with which they can create criteria as they see fit for their study.

The real-world case study presented was from ObjectiveHealth’s own sites and a nonalcoholic steatohepatitis (NASH) trial that is currently ongoing. 

More on the entire presentation can be found 

Colleen Hoke, co-founder and CEO, ObjectiveHealth discusses what the future of patient recruitment could look like at the 2023 DPHARM conference in Boston, MA.

DPHARM 2023: Future of Patient Recruitment

In an interview at the 2023 DPHARM conference with ACT editor, Andy Studna, Colleen Hoke, co-founder and CEO, ObjectiveHealth, discusses the challenges she is currently seeing in patient recruitment including the role of trust and personalized medicines.

Trust. I'd say patients have to trust the process. They trust in their doctor. They have to trust it's the right thing for them. They have to trust that it will fit in their lifestyle and I think we have to overcome that as an industry and there's all different types of research. There's lots of different people trying to address it in lots of different ways and it all needs to happen. There's really a huge mismatch between supply and demand; demand in terms of improving our lives with personalized medicine. It's going to take a number of different solutions to get the right patients to the right trials, but I would say trust is paramount and then I think we're lacking a framework to support patients and their doctors or patients and their caregivers and we're all trying to build that too.

Colleen Hoke, co-founder and CEO, ObjectiveHealth discusses the challenges industry is currently seeing in patient recruitment at the 2023 DPHARM conference in Boston, MA.

DPHARM 2023: Challenges in Patient Recruitment

In this session at DPHARM 2023, Colleen Hoke, co-founder and CEO, and Josh O’Rourke, chief technology officer; both with ObjectiveHealth explored a real-world case study demonstrating the combined impact of its enrollment solutions: ObjectiveScreen and ObjectiveView.

Following an introduction from Hoke, O’Rourke emphasized the impact of the solutions on the company’s own clinical trial sites. “This year, these have gone a long way in accelerating trials within our own sites, enabling transparency to our sponsors,” he said. ObjectiveHealth began offering them as solutions outside of its own site network in 2023.

The real-world case study presented was from ObjectiveHealth’s own sites and a nonalcoholic steatohepatitis (NASH) trial that is currently ongoing. Following intervention from ObjectiveScreen, which included machine learning for NASH risk, rules-based matching for criteria, and optimized patient prioritization for targeted recruitment, the number of eligible patients increased from 12.5% to 46.4%. A jump in screened patients occurred from 19.9% to 51.2%, enrollment rate increased from 10.9% to 23.1%, and screen fail rate dropped from 89.1% to 76.9%. These changes occurred over the span of 8 weeks.

Accelerating Clinical Trial Enrollment: Unleashing the Power of EHR Integration and Intelligent Patient Matching. September 21, 2023. DPHARM 2023, Boston.

ObjectiveHealth presents real-world case study on enrollment solutions in DPHARM 2023 session.