November 2022


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Editorial Board

Content stream editors

Translational science
Gary Kelloff US National Institutes of Health
Ilan Kirsch Adaptive Biotechnologies Corp.

regulatory science
Isaac Rodriguez-Chavez ICON plc

Patient engagement
Trishna Bharadia Patient Advocate and Media Contributor
Mary Stober Murray National Minority Quality Forum

Editorial Staff

Alberto Grignolo, Editor-in-Chief Parexel International

Sandra Blumenrath, Managing Editor, Scientific Publications DIA Scientific Communications

Chris M. Slawecki, Senior Digital Copyeditor DIA Scientific Communications

Regional Editors

David Mukanga Bill and Melinda Gates Foundation

Jin Shun Sandoz

Richard Day University of New South Wales, Medicine, St. Vincent’s Hospital

Ling Su Shenyang Pharmaceutical University, Lilly Asia Ventures

Julie O’Brien Pfizer

J. Vijay Venkatraman Oviya MedSafe

Ozawa Goshi Real Discovery Outdoors Co,. Ltd.

Cammilla Gomes Roche

Ebony Dashiell-Aje BioMarin

Young Professionals Editor

Kaley Lugo Daiichi Sankyo

DIA Membership

Bringing together stakeholders for the betterment of global health care.

Introduction: The Digital Virtuous Loop

igital health data technology is transforming clinical research and therapeutic product development from a straight-line model (with data flowing “from beginning to end” to inform sequential, gated phases) to a self-reinforcing feedback loop–a digital virtuous loop that informs the entire product development lifecycle in an iterative manner.

Data Standards Optimize Patient-Centric Clinical Trials
Richard Young
Veeva Systems

ne fundamental challenge facing life scientists is establishing standards for clinical data sharing that enable decentralized or digital trials. During the 30-plus years that the Clinical Data Interchange Standards Consortium (CDISC) has been in place, the ways that the biotechnology and pharmaceutical industries think about data have changed significantly.

Cloud Cover: Accelerating Global Medicines Development, Assessment, and Patient Access
With cloud-based data storage, computation, and sharing already changing other aspects of the life sciences, some organizations are pursuing the cloud’s potential power to streamline clinical research data submission and regulatory review. “The overall vision is to be able to submit once and having regulatory authorities accessing the same information in parallel,” says Dominique Lagrave (Accumulus Synergy). “Each authority may have different timing depending on their regulatory processes, but the end is that once the information is made available, all health authorities have access to this same information and collaborate.”
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Case Study: Finding the Needle in the Haystack
How Technology Can Help Match Cancer Patients with Cancer Trials
Selin Kurnaz
Arturo Loaiza-Bonilla
Massive Bio

ore than 18 million Americans have been diagnosed with cancer in the past decade, according to the American Cancer Society. This is by any measure a staggering figure. And while the past century’s scientific advancements have greatly improved detection, treatment, prognosis, and life expectancy for these patients, there is still much work to be done in the search for a cure.

Bench to Bedside to Bench: Value of Data Loops
Surging global innovation in data analysis and related technologies has created a data-driven sea change in the healthcare product development lifecycle. “Once a product goes into a human being, how does that information that gets developed as a kind of phase 4 trial go back into expanded uses, new indications, or patient populations that haven’t been addressed before?” asks Brooke Casselberry (NNIT).
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Digital Revolutionizes Data-Driven Reimbursement

Digital technologies are rippling through clinical research and care, promising deeper links between healthcare research and delivery. In her interview with Global Forum US Editor Ebony Dashiell-Aje (BioMarin), Digital Medicine Society CEO Jennifer Goldsack expresses concern about the lag between producing evidence that something is fit for purpose and the conversations that need to take place with payers and HTA experts. “We don’t want to demonstrate, using the best, most novel measures possible, that new therapies are making a meaningful change for patients in ways that we haven’t been able to measure before but are critically important, then delay going to market because additional evidence is required by our payer colleagues because we haven’t taken time to take them with us.” Jennifer served as a panelist in the Paying for Digital Health: What Evidence is Needed? discussion at DIA Global Annual Meeting 2022.
Technology’s Burdens and Blessings for Patients in DCTs
Moving traditional trials to decentralized clinical trials (DCTs) means implementing the technology needed to realize their greatest benefits. In one study, 50 percent of sponsors and CROs agreed that the extra technology burden placed on patients is one of the biggest obstacles to decentralization. “There’s lots of fun ways we can get participants engaged, make their lives easier, and make it easier to do a clinical trial,” suggests Staci McDonald (Celerion). “But how many people have a smartphone, that’s a challenge we’re going to have to address. Right now, we are at about an 8 percent paper rate. That’s a real portion. We’re going to have to figure out how to solve for that.”
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More Than One Way to Crack a Walnut: Four Fundamental Components of a Successful Decentralized Clinical Trial
Joel Morse

Curavit Clinical Research


here’s more than one way to architect a decentralized clinical trial (DCT). While this flexible model has many benefits, it can be overwhelming to bring together all the right elements to operationalize a trial that’s predominantly digital. Every trial is unique, so it is not realistic to templatize (impose a standard implementation template on) a DCT. But four common, fundamental components combine to facilitate a seamless, patient-centric DCT.

“It’s like a trial in a box, but each box is a little bit different,” said Steve Rosenberg, CEO of a cloud-based platform company that powers decentralized clinical trials. Even with a DCT’s inherent optionality, foundational components can ease implementation and improve execution.

Strength in Numbers: Distilling RWE into Clinical Practice
The clinical impact of real-world data gathered from electronic health records, pharmacy claims, and other sources is reaching into the connections between research and care. “Think about access for patients,” suggests Verantos founder and CEO Dan Riskin. “In real places where real people are getting care, we see a diversity of population consistent with the populations being treated. We get answers and evidence of how it’s working in that population. We can properly prescribe with evidence, and that’s the ultimate form of access.”
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Right Time for Roadmap to Harmonizing RWE?
EU Industry Perspective on Future Directions
Karin Van Baelen
Janssen Pharmaceutica, NV
Susan Sandler
Janssen-Cilag Limited
Álmath Spooner

eal-world evidence (RWE) policy is evolving around the world, with increasing recognition that RWE offers a value proposition for all stakeholders in the research, development, and healthcare ecosystem. In the European Union, the European Health Data Space (EHDS), if optimally implemented, has the potential to advance the concept of a learning healthcare system that enables not only sharing of data but also sharing of insights. This concept provides a vision for a future when improved, more connected use of data will enhance decisions on therapies for individual patients, with feedback loops from clinical practice to research and development, and then back again, with each helping the other to make better decisions faster.

Integrating Sensor-Generated Data into Data Platforms to Power Clinical Research & Patient Care
Wearables are building growing connections between patients, clinical trials, and caregivers and are delivering unprecedented high volumes of sensor-generated data. Greater computational powers now allow us to make increasingly valuable use of these data. “We should be much better at hypothesis generation based on the data we see,” says Digital Medicine Society CEO Jennifer Goldsack. “We can use real-world data to do that. Then we can determine whether a single patient who meets our inclusion/exclusion criteria actually exists.”
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The Value of Digitized Medicines for Patient Engagement
Jeannette Tighe
TruTag Technologies

he pharmaceutical industry has embraced digital transformation as a means of generating data that enables faster and better-informed decision making. Digitization has resulted in improved cohesion and overall effectiveness across the pharmaceutical value chain.

Thanks for reading our November 2022 Issue!
Views and opinions expressed in Global Forum are those of the authors alone and do not necessarily represent those of DIA or any other agency, organization, employer, or company. DIA does not guarantee the accuracy or completeness of any information published in Global Forum and will not be responsible for any errors, omissions, or claims for damages, including exemplary damages, arising out of use, inability to use, or with regard to the accuracy or sufficiency of the information contained in Global Forum.