Rethinking Clinical Trial Design with Translational Models and Digital Tools
By: Soumya Shashikumar, MBiotech
Interviewee: Edwin Tucker, MD, past Chief Medical Officer, Jasper Therapeutics
Rethinking Clinical Trial Design with Translational Models and Digital Tools
By: Soumya Shashikumar, MBiotech
Interviewee: Edwin Tucker, MD, Chief Medical Officer, Jasper Therapeutics
Despite decades of investment in clinical research, participation in trials remains persistently low.
According to the 2020 Health Information National Trends Survey (HINTS), only 9% of US adults reported ever being invited to participate in a clinical trial — and among those, just 47% accepted. Structural barriers such as limited provider engagement, geographic access and trial burden were noted to restrict broader participation.
The urgency for better solutions is also reflected in the market: the clinical trial technology and services sector is projected to reach $60.8 billion by 2030, driven by the demand for digital platforms that can streamline recruitment, improve patient engagement and enhance regulatory compliance.
With about 80% of trials failing to meet enrollment timelines, digital innovation could enable faster, more inclusive research.
So, how can trial sponsors rethink clinical development to be more efficient, inclusive and responsive, without sacrificing scientific rigor?
In this Xtalks Clinical Edge interview, Dr. Edwin J. Tucker, past Chief Medical Officer (CMO) at Jasper Therapeutics, shares how transgenic animal models, digital tools and patient-reported outcomes (PROs) are shaping a more efficient and inclusive approach to clinical trials — from early-phase safety to patient-centric protocol design.
This interview with Dr. Tucker was conducted in 2025 when Dr. Tucker was the current CMO at Jasper Therapeutics.
Investigating Mast Cell Biology: A Dual Opportunity
Dr. Tucker opened by discussing how recent advances in clinical research — particularly those involving investigational monoclonal antibodies — are being explored for their ability to deplete mast cells, offering valuable insight into mast cell-driven conditions.
In certain areas, such as respiratory disease, sustained mast cell depletion is enabling researchers to better understand the long-term role these cells play in inflammatory processes. This combination of therapeutic potential and scientific value may help inform future decisions around indication selection and clinical trial endpoints.
Agile Preclinical Models with Translational Value
Recognizing the importance of preclinical systems that meaningfully inform real-world outcomes, Dr. Tucker illustrated the value of having what he called “agile technology” that supports faster and more informed clinical development decisions.
At Jasper Therapeutics, one such approach involves a proprietary transgenic model engineered to express a humanized receptor involved in mast cell biology.
This preclinical platform allows researchers to evaluate the in vivo behavior of humanized monoclonal antibodies in areas such as:
- Food allergy
- Dermatitis
- Asthma
- Additional respiratory conditions, with new data expected to emerge soon
According to Dr. Tucker, these models improve the ability to identify early signals and refine the direction of clinical programs more efficiently.
“Only about 10% of patients available in the world actually come into a clinical study, which is incredibly disappointing for our industry where we’re trying to find new solutions and it’s often rate-limiting across industry for studies when finding patients.”
— Edwin Tucker, Chief Medical Officer, Jasper Therapeutics
“Only about 10% of patients available in the world actually come into a clinical study, which is incredibly disappointing for our industry where we’re trying to find new solutions and it’s often rate-limiting across industry for studies when finding patients.”
— Edwin Tucker, Chief Medical Officer, Jasper Therapeutics
Digital Tools Are Changing the Way Trials Are Designed
“I don’t think it’s a one-size-fits-all,” stated Dr. Tucker when speaking to clinical trial design and execution. He emphasized that digital technologies, including AI and analytics platforms, are playing a growing role in trial design, especially when used to reduce the burden on both patients and investigators.
A few key aspects to keep in mind were:
- Protocol Simulation: Modeling tools can evaluate how a trial might impact patient and physician time, taking into account geographic and socioeconomic factors. These simulations also account for regional or socioeconomic barriers, allowing for more equitable recruitment planning.
- Enrollment Optimization: Simulations can also help identify barriers to participation and tailor attractive protocols to maximize engagement.
- Endpoint Selection: Examples such as the Urticaria Activity Score over 7 days (UAS7) — a validated tool for measuring disease activity — and the Urticaria Control Test, which helps support regulatory alignment, are increasingly being used as endpoints. Dr. Tucker noted that such measures could reflect meaningful changes in disease burden.
“Only about 10% of patients available in the world actually come into a clinical study, which is incredibly disappointing for our industry where we’re trying to find new solutions and it’s often rate-limiting across industry for studies when finding patients,” he said.
As Dr. Tucker mentioned, the industry continues to face challenges with trial speed and overall success rates — gaps that underscore the value of new digital and analytic approaches.
Elevating the Patient Voice in Outcome Measurement
Involving patients directly in outcome measurement is gaining traction across inflammatory disease trials. Dr. Tucker emphasized that patients are often the best source for capturing day-to-day symptoms like hives or itch — and they increasingly want to contribute.
“Patients want to be involved, they don’t want a doctor to measure their disease, they would like to tell you their disease,” said Dr. Tucker.
Tools like the Urticaria Control Test allow researchers to validate what patients report through cross-checks against other outcome measures, increasing data integrity from the ground up.
According to Dr. Tucker, these patient-centered methods do more than improve data quality. They also support faster development timelines.
“All of those things enhance both the quality of the data and the speed to market. That is really key for us because there are two things that we are not doing as an industry — we are not very fast and we are not very successful,” he added.
Actively shaping how disease is measured will enable trial designs that better reflect lived experience — and may be more likely to succeed.
“It’s trying to find that balance between a patient who’s motivated to come into a clinical study and not having to overburden those patients where they’re in the hospital for four or five hours waiting for yet their next test.”
— Edwin Tucker, Chief Medical Officer, Jasper Therapeutics
“It’s trying to find that balance between a patient who’s motivated to come into a clinical study and not having to overburden those patients where they’re in the hospital for four or five hours waiting for yet their next test.”
— Edwin Tucker, Chief Medical Officer, Jasper Therapeutics
Rethinking Safety and Insight in Early Phase Trials
In early phase trials, Dr. Tucker reaffirmed that safety remains the top priority. He highlighted the continued use of:
- Measured dose escalation protocols
- Independent data monitoring committees
- Innovative biomarkers to gather translational insights, even if they are not yet validated for registration
These designs also allow for detailed pharmacokinetic assessments, providing insight into how investigational agents behave in the body, even at the earliest stages of development.
This cautious, layered approach could allow sponsors to extract valuable data from small studies while minimizing risk to participants.
Designing Around the Patient Experience
Trial participation often requires patients to balance work, family and personal obligations. Overly long or complex visits can quickly discourage enrollment, especially when trials don’t account for the realities of daily life.
Dr. Tucker explained that early engagement helps researchers capture not only the scientific needs of a study, but also what is and isn’t working for patients throughout their trial experience. This includes understanding visit duration, scheduling challenges and the competing demands patients face, such as caregiving or religious commitments.
Today, software tools can help sponsors estimate the time patients are likely to spend during each visit, something Dr. Tucker noted was unavailable just a few years ago.
“It's trying to find that balance between a patient who’s motivated to come into a clinical study and not having to overburden those patients where they’re in the hospital for four or five hours waiting for yet their next test,” said Dr. Tucker.
Not only that, he highlighted that it’s about appreciating the choices patients make regarding a clinical trial, drug or therapy, even when considering off-label use.
Crossing these logistical concerns through better planning and patient input can create clinical studies that are more accessible and less disruptive.
The Ongoing Need for Operational Innovation
When asked about the biggest challenges facing clinical research over the next five to 10 years, Dr. Tucker pointed to long-standing issues around operational efficiency and regulatory alignment.
He highlighted new efforts to reduce the use of animal models in biologic development and noted signs that regulators are becoming more open to innovative development pathways.
Dr. Tucker concluded the interview on a thoughtful but optimistic sentiment, “It takes a village to deliver a new medicine that involves regulators, investigators, investors and also biotech professionals at the various companies. We have to keep pressing the innovation button every day to make these things happen.”
ABOUT Edwin Tucker
Edwin Tucker has over 30 years of clinical experience leading novel drug development. Dr. Tucker was most recently Chief Medical Officer at Goldfinch Bio, where he led clinical development and helped build the regulatory, medical affairs and clinical operations functions. Previously, he served as Chief Medical Officer at Mirum Pharmaceuticals, where he contributed to the achievement of key milestones in the development of medicines for adult and pediatric cholestatic liver disease, including the first FDA approval for Alagille syndrome. Prior to joining Mirum, Dr. Tucker was at Acerta Pharma LLC, now part of the AstraZeneca family of companies, ultimately serving as Chief Operating Officer. Prior to joining Acerta, he held leadership positions in development, medical safety and medical affairs at Genentech, Janssen Research and Development and Bayer HealthCare Pharmaceuticals.
Dr. Tucker is a member of the Royal College of Physicians (UK) and received his MBA from the University of Connecticut. Dr. Tucker holds degrees in Pharmacology and Medicine from the University of Leeds, United Kingdom. Additionally, he serves as a Managing Director at Golden Seeds, an investment firm dedicated to pursuing early-stage investment opportunities in women-led businesses.