Don Tracy

In this session at DPHARM 2023, Steve Rosenberg, CEO, uMotif, offered insights on the constantly improving innovations in digital technology and how it related to clinical trial patients.

Rosenberg launched into the session with a brief background on joining uMotif. After initially retiring in 2020, he rejoined the workforce to run Motif after a couple of months on its board. He then began with his thoughts on handheld technology.

“The evolution of handheld technology is something new that’s represented by the type of proposal proposed with all these new apps and capabilities,” Rosenberg stated. “Back when PHT was a pioneer, it basically had to use paper instruments for being validated from the screen, and that’s when we started out. That’s still what the state of most of the product is today, you have this validated sticker on your device or tablet, and you get the patients to fill that out.”

When the team was formed a decade ago, they initially wanted to help patients record and share their health with the doctor. However, they soon realized that in order to achieve success, it would have to be through the patient’s device. “It had to compete with Instagram and Twitter,” explained Rosenberg. “I pick up my phone eight times a day and what do I do? I check the apps and email, maybe even a lot of stupid pet videos. That was something they had to compete with.”

As a result, uMotif came up with a new user interface for patients to answer questionnaires where they simply slide to the next question on their phone.

Rosenberg summed up his presentation with opportunities for the future. “80% of studies with patient reports, only half of them are electronic with a lot of them still on paper,” he stated. “There’s an opportunity here to take the current paper and make a patient experience that takes advantage of their device that they use every single day.”

The Evolutionary Impact of Mobile Devices on eCOA/ePRO. September 21, 2023. DPHARM 2023, Boston.

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Steve Rosenberg, CEO, uMotif, discusses how patients would like to be involved in clinical trials as innovations in digital technologies continue to evolve. 

DPHARM 2023: The Evolutionary Impact of Mobile Devices on eCOA/ePRO

In the discussion “Zeitgeist Talk on the Current and Future State of Health Data Interoperability,” held at the 13th annual DPHARM conference in Boston, Micky Tripathi, PhD, MPP, national coordinator for health information technology, US Department of Health, answered questions from Amy Cramer, MMCi, BSN, CPHQ, founder, board of directors co-chair, Vulcan, HL7 FHIR® Accelerator, on the current status of USCDI and TEFCA and the next steps to advance evidence generation systems.

The following has been edited for length and clarity.

What got you excited about HL7? Specifically, the fast healthcare interoperability resource and the Argonaut accelerator?

Back in 2014, I was a part of the health IT policy committee. There was a report cast on who could provide technical advice and strategic advice to the federal government. One of the things that was pointed out was that healthcare needs to discover the internet and the internet needs to discover healthcare. In other words, healthcare needs to move to an application programming interface (API)-based framework, like the rest of the internet economy. During a meeting, a group of us got together and decided to take the initiative. I was asked to be the project leader for the API. That’s when I got involved and it was really exciting.

: I want to talk a little bit about CDI. What can you tell us specifically about USCDI?

: The USCDI is the US Core Data for Interoperability. It’s the minimum data set that is required to be supported by all certified electric health record systems. The idea is that it needs the 80/20 rule. Hopefully, all of us agree that we should have a minimum data set across the country that’s basically the least common denominator that you can count on, whether it be in Juneau, Alaska, or Portland, Maine.

One of the things we hear from our scientists a lot is getting specific data elements and lab data is a great one to move in. When you receive data, you can put anything you want in there. If you don’t get those research resources, it’s hard to get out. The calendar of events for a research study is very dynamic and very different from clinical care. So, when can we have our research resources? What's your expectation for that?

We don’t have a fixed timeline currently. I think it's sort of driven in part by our ability to work with our agency partners on things like the USCDI+, for research and for clinical trials, for example, there's very specific data elements that are much more exacting than the general kind of data that we use for the USCDI, and in some ways are used for clinical care. I think that's where we rely on accelerators, like Vulcan, for example, to be able to identify some of these things and say, these things aren't yet at the level of maturity that we need for set standards. Let's accelerate those through the process to get those more standardized. That puts us in a position of being able to say that these are at a level of maturity now that we're able to put them in the pipeline.

: Let’s talk about TEFCA, it stands for Trusted Exchange Framework and Conference Agreement.

: TEFCA is from the 21st Century Cures Act 2016 to establish a nationwide model for network-to-network interoperability. Think about the way that cell phones and ATMs work today. We have the user experience of there being a single cell phone network across the country, right? That's our experience. We don't worry about any Verizon phone, I bought AT&T. They don't think about that for a minute. And that's because there's a ton of work that's gone on behind the scenes such as governance, technical specifications, and industry collaboration that makes sure that those systems are connected, even though it's actually a set of private networks that connect on the back end. That was essentially the direction that Congress gave us to say do the same thing with clinical interoperability networks. There are a number of them out there, there are state and local ones, some of which are on their last breath, but some of which have sustainability, and they will continue going forward.

: There are people out there that are critical of TEFCA, and they are colleagues that we highly respect. They feel that the way TEFCA is set up will set back inoperability two years. What would you like to do to respond to people that we respect in that space?

: We have ongoing discussions with all of the individuals who we are talking about here, and we certainly appreciate their points. I think a part of that criticism is two things. One, I think it reflects comments back on our draft rule, which was published. We have those to get feedback and comments. I would encourage everyone to wait until you see a final rule before you make your judgements about TEFCA. We’re the ones that have been very invested in FHIR from the beginning. So, the fact that we would do anything to undercut the adoption of FHIR APIs seems to not have a lot of credibility. The second thing that is important for us all to understand is that FHIR APIs have will have great difficulty scaling without the networking infrastructure that TEFCA provides. You can have a FHIR API, and let’s say what you want to do is access information from 1000 different provider organizations across the country. First question you're going to have is, where are the data use agreements on all of those? Second question, who's handling the onboarding and the security for that kind of exchange? Again, am I going to have to do that? And is every CRO going to have to do that with the same set of providers? Third, where are the electronic endpoints for those 1000 providers? I need an electronic address. My technical team is going to say, what's the URL? Where do I point this? That was enough for them to make the phone call and write it down? Or say, please email me your electronic address. Fourth, where are patients’ records? You need to know to order the patient records and where the addresses are. Without the infrastructure of TEFCA, you’ll have to figure that all out on your own.

Zeitgeist Talk on the Current and Future State of Health Data Interoperability. September 21, 2023. DPHARM 2023, Boston.

Session discusses next steps to advancing evidence generation systems.

DPHARM 2023: Current and Future State of Health Data Interoperability

When it comes to selecting Digital Health Technologies (DHT) providers, there are numerous factors that need to be considered when deciding.

In the discussion, “Key Considerations for Evaluating and Selecting Technology Suppliers for Digital Health Technologies,’ held at the 14th Annual Summit for Clinical Ops Executives (SCOPE) meeting in Orlando, Sonali Bhatnagar, associate director of clinical innovation & digital health, R&D, sourcing & procurement for Merck, examined the trials associated with evaluating, selecting, and onboarding new suppliers and the questions that should be considered.

Bhatnagar explained the need to include enough time for negotiating, or it could lead to a frustrating experience. “We need to make sure we build enough time to build a relationship with the supplier and deliver good things for our patients,” she said.

She also stressed the importance of understanding the role of subcontractors, and the extent that they impact the project. “If they were to be acquired, we would need to have a backup plan. Ultimately, we’re responsible for getting data back. We need to make sure we’re having those conversations with subcontractors beforehand.”

Communication is vital to selecting the correct vendor…companies need to make expectations clear prior to any agreement. “Responsibilities need to be clear in regard to what we are doing, what they are doing,” explained Bhatnagar. “Tie-in your milestones to payments.”

At each stage of negotiations, Bhatnagar believes that an appropriate assessment should be conducted.

“We want to build fast, but we also want to follow our policies and keep going,” she said. “Have a conversation at each stage to see how things are going.”

Key performance indicators (KPI) were also recommended as something important to the negotiation process, especially for newer vendors. According to Bhatnagar, KPIs can be helpful based on the scope of the project, and where they make sense.

Bhatnagar wrapped up her presentation with some final thoughts to consider. These include:
•	Does it work the way we expect it to?
•	What are the regulatory implications?
•	What markets are we thinking?
•	What would the cost of clinical trials look like?

Reference
Bhatnagar, Sonali. Key Considerations for Evaluating and Selecting Technology Suppliers for Digital Health Technologies. Presented at : SCOPE; Feb. 6-8, 2022; Orlando, Fla.


SCOPE session discusses key challenges of evaluating potential providers. 


Tips for Selecting Digital Health Technology Suppliers

In the discussion: “Novel Evidence for Regulatory Decisions: The Key Factors for Success,” held at the 14th Annual Summit for Clinical Ops Executives (SCOPE) meeting in Orlando, panel members offered suggestions on how to successfully implement novel evidence—defined as RWE, digital biomarkers and novel digital endpoints—in the life cycle of drug development. The panel, moderated by Michelle Crouthamel, D.BA, head of digital sciences for AbbVie Inc., consisted of Jennifer Goldsack, CEO of Digital Medicine Society (DiMe); Christopher Boone, VP, global head of health economics of AbbVie Inc., and Amy Abernethy, president of Verily Life Sciences.

Boone kicked off the discussion, explaining what he’s noticed across the industry and suggested preliminary steps to take. “We’re seeing an awakening in the pharmaceutical industry,” he said. “It’s not just about R&D and regulatory approval but thinking about our evidence plans and the continuous evidence generation across the life cycle of an asset is very important.”

Boone also noted Crouthamel leads AbbVie’s digital science team, which “accesses the landscape of these novel technologies and certifies their usefulness before we put our hands on them.”

Abernethy described her own experiences using novel evidence through Project Baseline, a study that enrolled 2,500 individuals in order to create a 360-degree view of health.

“Reflected across time, this view of health included clinical data, echocardiograms, and visits with clinicians,” she said. “It also included wearing sensors on the wrist in order to understand movement and sleep across time. The sensor was also able to alert participants to answer questions, helping understand their story over time.”

Abernethy stressed that in the end, the science matters. “We have to do the hard work of understanding performance, reliability, and the correct context for intended use.”

Goldsack agreed: “When we think about a digital health model, we aren’t thinking about a single proprietary product, but about a high performing sensor technology, coupled with a trustworthy algorithm that works in every single person,” she explained.

Crouthamel asked the panelists for key takeaways.
“The number one thing to think about is building scalable infrastructure at which we can do this science,” said Abernethy. “Longitudinal infrastructure that sets up the mechanism to continuously validate all of the endpoints that we are talking about. We need to set a scale so that we don’t have to do this over 40 years, but only a few.”

Boone continued by stating, “The data infrastructure piece is very important. The upscaling and rescaling in addition to building longitudinal data points is key.”

Goldsack agreed. “I think that what the infrastructure affords us to do is have a more thoughtful digital strategy that transcends these individual slings shots. That allows us to think about how we capture return on investment for our business and for the patients through the development of these new tools. We need appropriately trained colleagues to make this happen. Pathways to ROI need to exist.”

Reference
Crouthamel M, Goldsack J, Boone C, Abernethy A. Novel Evidence for Regulatory Decisions: The Key Factors for Success. Presented at: SCOPE; Feb. 6-8, 2022; Orlando, Fla.

Panel at SCOPE discusses applying novel evidence in regulatory decision-making. 






Expert Insights into Novel Evidence 

Despite ongoing challenges following the COVID-19 pandemic, there is a lot of optimism about the future of drug research.

In the discussion: “Navigating a Global Crisis: Pandemic, War, Hyperinflation, Supply Chain Disruptions…You Name It,” held at the 14th Annual Summit for Clinical Ops Executives (SCOPE) meeting in Orlando, members of a panel noted the challenges imposed on clinical trials because of the COVID-10 pandemic. The panel, moderated by Balazs Flink, senior director of clinical development operations at Daiichi Sankyo, included:
Gaurav Sawhney, VP, head, clinical partner management, Takeda Pharmaceuticals Inc.; Deborah Profit, PhD, VP of clinical management & applied innovation, Otsuka America Pharmaceutical, Inc.; Ken Getz, MBA, founder of CISCRP; deputy director of the Center for the Study of Drug Development, Tufts University School of Medicine, and Bryan O’Neill, global head of clinical supply operations at Daiichi Sankyo, Inc.

Profit said that Otsuka leveraged quantitative and qualitiative data during the pandemic to respond to the pandemic, shifting resources when necessary from more impacted areas to less. She said they also gathered data on how their employees were impacted, as well as site trial areas to make decisions about research.

“This is our moment, quite honestly,” said Profit. “This is our opportunity to take what we’ve learned through the pandemic to do better.”

Getz noted that while there are opportunities for improvement, “the long-term outlook is remarkably positive and optimistic.”

He noted that pipelines are growing by three to four percent a year, with major areas of focus centering on rare diseases and personalized medicines. “Sixty percent of all drugs approved are relying on biomarker or genetic information to really target a therapy and there’s huge promise there.”

While there is no shortage of optimism for the future, the experts agreed that there is still room to grow.

“What we still need to understand are the intangible ways that we collaborated as a team,” said Getz. “We are often trying to draw lessons from how we handled and succeeded in addressing a global pandemic.”

In addition to the challenges that Getz spoke about, O’Neill also discussed ongoing supply chain issues.

“When supply chain staff are stricken with COVID-19 protocols, we all of the sudden have a very high touch process that is not very vendor friendly, especially when they are trying to deal with personnel challenges,” said O’Neill. “For me, there was a great deal of learning during the pandemic and figuring out what would work to keep the supply chain flowing.”

Flink B, Profit D, Sawhney G, O'Neill. Navigating a Global Crisis: Pandemic, War, Hyperinflation, Supply Chain Disruptions…You Name It . Presented at: SCOPE; Feb. 6-8, 2022; Orlando, Fla.