Why Digital Clinical Trials Need More Than Digital Tools
By: Soumya Shashikumar, MBiotech
Interviewee: Jennifer Goldsack, CEO, Digital Medicine Society (DiMe)
Why Digital Clinical Trials Need More Than Digital Tools
By: Soumya Shashikumar, MBiotech
Interviewee: Jennifer Goldsack, CEO, Digital Medicine Society (DiMe)
Clinical research is facing mounting pressure. Protracted development timelines, high failure rates and commercial uncertainty are forcing sponsors to rethink everything from trial design to pricing strategy.
According to a 2023 Grand View Research report, the global clinical trials market surpassed $80 billion, with the North American segment alone expected to grow from $41 billion in 2023 to over $60 billion by 2030. Meanwhile, funding for clinical-trial technology — covering AI recruitment platforms, digital biomarkers, decentralized platforms and blockchain — reached more than $5.5 billion last year. These figures reflect not only growing investment in innovation, but a rising expectation that it delivers measurable impact.
While digital technologies are often touted as the fix, Jennifer Goldsack, CEO of the Digital Medicine Society (DiMe), believes the solution demands more than tools — it requires intention.
In this interview, Goldsack shares a clear-eyed view of where digital solutions can make an impact, the misconceptions holding the field back and what it will take for the industry to stay viable in the years ahead.
The Promise — and Limits — of Digital in Today’s R&D Climate
Goldsack emphasized both the promise and the limits of digital innovation in clinical research.
“Do I think that digital technologies offer enormous promise to transform the way that we develop new medical products? Yes, absolutely,” she said. “Do I think that shoehorning technologies into every nook and cranny of clinical research is suddenly going to create an industry that's sustainable in the current environment? Not without an awful lot of intention.”
Goldsack pointed to external pressures, such as US drug pricing reforms, including expanded price negotiation and proposed international pricing benchmarks. Together, she said, these trends will likely reduce global revenue for biopharma developers.
At the same time, clinical timelines are stretching, not shrinking. Trials continue to center on historically tough therapeutic areas like CNS, diabetes, oncology and obesity. Diagnostics for rare diseases have improved, but treatment development hasn’t caught up.
“We can diagnose those diseases, but we still have to look those parents in the eye and say there’s absolutely nothing that we can do for you,” she said.
She added that the industry still faces a 10- to 15-year development timeline and a 95% technical failure rate — while the commercial upside is diminishing.
For Goldsack, these converging trends require not just optimization, but a reimagining of how therapies are developed and delivered.
From Discovery to Post-Market: Where Digital Can Deliver
Goldsack sees potential for digital technologies across the full development lifecycle.
In early discovery, she pointed to AI’s role in identifying novel targets, particularly as public funding for foundational research declines.
Beyond discovery, digital phenotyping and patient-generated data can help identify population subgroups most likely to benefit from treatment.
Digital tools can also improve trial execution. Smart onboarding and deeper screening enhance signal detection and retention. Hybrid models that pair virtual tools with local clinical infrastructure can expand access.
She added that AI-driven monitoring of scans and images can automate oversight, while digital endpoints continue to improve cost, timeline and inclusion metrics.
Even post-approval, digital solutions remain valuable. Companion apps can support adherence and outcomes, shaping payer negotiations. Goldsack cited GLP-1 makers using telehealth platforms as one example.
She also spotlighted DiMe’s work on a sensor-driven early warning system for cytokine release syndrome (CRS), which could enable outpatient immuno-oncology trials and reduce costs, while accelerating timelines and improving real-world access.
“These are the sorts of things across the whole life cycle that we need to be thinking about,” she said. “And, I don't know what the plan is for an R&D-heavy industry to sustain over time unless we capture all of those opportunities.”
“It’s not about ‘I want to get good at AI.’ It’s about, I want to think about the particular pain point my team is dealing with.”
— Jennifer Goldsack, CEO, Digital Medicine Society (DiMe)
“It’s not about ‘I want to get good at AI.’ It’s about, I want to think about the particular pain point my team is dealing with.”
— Jennifer Goldsack, CEO, Digital Medicine Society (DiMe)
Misconceptions, Regulation and the Real Barriers to Change
The biggest misconception isn’t technical — it’s organizational, according to Goldsack.
Goldsack argued the real gap isn’t resistance from agencies like the FDA, which have issued final guidance on decentralized trials (DCTs) and digital health tools. Instead, it’s the industry’s hesitancy to implement.
“The technology is outpacing regulation, but the industry is being outpaced by regulation.”
She used DCTs to illustrate this point. In one study, digital tools reduced in-person visits from 12 to four, with the rest handled by local labs. Yet over half of the blood samples arrived coagulated due to transport issues — a solvable but neglected logistical barrier.
While the digital systems worked, operational basics failed. She stressed that these kinds of problems, not the technology itself, are limiting progress.
Despite the pandemic revealing strong patient demand for virtual care, the industry remains slow to adjust.
“We are being too slow to figure out the nuts and bolts of getting this right. And digital is not the limiting factor,” she says.
Patient-Centered Impact — and How to Get There
To make trials more meaningful and accessible, digital tools must focus on capturing real-world impact.
Goldsack shared two recent examples of digital endpoints helping regulators evaluate drugs for Parkinson’s disease. In one case, tremor was captured using continuous digital measures — far more sensitive than traditional rating scales.
She reflected on a patient she met in 2015: a trained scientist living with Parkinson’s who spoke candidly about how his symptoms made it hard to button a shirt or use lab equipment. Under stress, things got worse, but existing measures couldn’t reflect what he was going through. Tools like finger-tapping tests lacked the granularity needed to support drug approvals.
Sleep tracking in Alzheimer’s trials is another example. Caregiver burden, driven by patient restlessness, emerged as a major driver for placement in long-term care — and became a meaningful endpoint.
In rare pediatric diseases, she added, digital endpoints and decentralized approaches are helping overcome cost barriers and unlock R&D investment.
“That’s what makes it more meaningful,” she says.
Meaningful means empathetic and feasible. Trials that are more patient-centric are often more fundable.
She urged companies to prioritize outcomes like shortened enrollment timelines, improved technical success rates, more representative datasets and payer-relevant evidence.
“Stop talking about AI. Stop talking about digital endpoints. Start talking about increasing your technical success rate… and then just do it,” she asserted.
“Do I think that digital technologies offer enormous promise to transform the way that we develop new medical products? Yes, absolutely.”
— Jennifer Goldsack, CEO, Digital Medicine Society (DiMe)
“Do I think that digital technologies offer enormous promise to transform the way that we develop new medical products? Yes, absolutely.”
— Jennifer Goldsack, CEO, Digital Medicine Society (DiMe)
Collaboration in Action: DiMe’s Current Initiatives
DiMe is currently leading two major collaborations — both aimed at solving problems that are too big or too expensive for individual sponsors to tackle alone.
The first centers on pediatric rare diseases. The effort brings together regulators, patient foundations, technology developers and sponsors to pre-competitively validate shared digital measures of function — like voice, mobility and cognition.
The goal: Reduce duplication and ease the burden on sponsors. Instead of building custom digital endpoints from scratch, companies would refine common tools to fit their study needs.
This strategy, she said, can unlock decentralized models and lower trial costs in low-population indications.
The second initiative extends DiMe’s work on monitoring CRS. A new prospective study will validate sensor data, test label strength and refine algorithms to support decision-making.
“It means we can start to move our immuno-oncology trials to the outpatient setting much more quickly,” she said.
Where to Begin and What the Next 3-5 Years Demand
For those new to digital medicine, Goldsack’s advice is simple: start with the problem, not the technology.
“It’s not about ‘I want to get good at AI.’ It’s about, I want to think about the particular pain point my team is dealing with.”
DiMe’s Digital Medicine Academy provides adult-learner-focused, case-based courses spanning regulatory, clinical and ethical considerations. The organization also works one-on-one with companies ready to move beyond molecule-by-molecule innovation toward platform-level strategies.
Goldsack also flags their ROI calculator for digital endpoints as a starting point: “It can fundamentally change the math around medical product development.”
Looking ahead, she sees a make-or-break moment.
“We are an industry that is somewhat in crisis right now,” she said.
Goldsack believes that visionary leadership might determine who survives — and thrives.
“It's going to be those organizations and those leaders that step up and have the courage to say, we are going to use the full armory of what's available in the digital era to do things differently,” she concluded.
As this Xtalks Clinical Edge interview reflects, digital tools are only part of the story — advancing digital clinical trials will depend on practical coordination, shared frameworks and a clear sense of purpose.
ABOUT Jennifer Goldsack
Jennifer C. Goldsack is the Founder and CEO of the Digital Medicine Society (DiMe), a 501(c)(3) non-profit organization dedicated to advancing digital medicine to optimize human health. Her work centers on applied, evidence-driven approaches to the safe, effective and equitable use of digital technologies across health, healthcare and research.
Before founding DiMe, Jennifer helped drive progress in two digital health start-ups, including one successful exit. She also served as a senior leader at the Clinical Trials Transformation Initiative (CTTI), a public-private partnership co-founded by Duke University and the FDA. There, she led several initiatives within CTTI’s Digital Program and was the operational co-lead of the first randomized clinical trial conducted using FDA’s Sentinel System.
Earlier in her career, she spent five years conducting research at the Hospital of the University of Pennsylvania, first in the Department of Surgery’s Outcomes Research group and later in the Department of Medicine. She then helped launch the Value Institute, a pragmatic research and innovation center embedded within a large academic medical center in Delaware.
Jennifer serves on the boards of the Coalition for Health AI (CHAI) and Sage Bionetworks. She is a member of the National Academies of Sciences, Engineering and Medicine’s Roundtable on Genomics and Precision Health, contributes to the World Economic Forum’s Digital Health Action Collaborative, and serves on the Executive Committee of the US Department of Health and Human Services’ National Committee on Vital and Health Statistics (NCVHS).
She holds a Master’s degree in Chemistry from the University of Oxford, a Master’s in the History and Sociology of Medicine from the University of Pennsylvania, and an MBA from the George Washington University. Jennifer is a retired elite athlete — a Pan American Games champion, Olympian, former world record holder and World Championship silver medalist.