Initial leap of faith inspires today’s fast-growing digital clinical trial movement
In clinical research, there is no such thing as ‘taking a leap of faith’ and yet the industry’s need for empirical certainty can sometimes thwart adoption of important innovation. Understandably, the life sciences industry traditionally only takes incremental, calculated chances based on scientific hypotheses, slowing progress while patients are, on the other hand, desperate for fast access to clinical trials and improved treatments.
Novel technology, however, could be the magic elixir that bridges the gap between industry’s innate cautiousness and patients’ need for speed.
This paradox was challenged by the COVID-19 pandemic, when the threat of rampant illness forced the global life sciences industry to suddenly leverage technology in new ways, sometimes for the first time. There was no other choice but to set up telehealth clinician visits and to provide patients with wearable devices, collecting data in ways not previously utilised at scale. Technology providers responded, delivering innovation at an unprecedented rate. New solutions flooded clinical research in torrents while regulators tried to offer tentative guidance and manage the flow. And new terminology, such as decentralised clinical trials (DCTs) and digitally enabled trials, were being defined and redefined, labelled and relabelled.
Change was the only constant – a dynamic that unsettled the innately prudent pharmaceutical mores.
Since 2020, many life sciences companies have moved back towards their familiar, cautious roots, taking stock of what did and did not work during challenging times, and implementing one trial at a time. To scale broadly and make a significant impact on clinical research without a pandemic forcing their hands, sponsors need evidence that electronic clinical outcomes assessments (eCOAs), wearable devices/digital health technologies, electronic informed consent systems, and other digital elements will work.
Today, there is now reliable evidence that digitally enabled trials provide value and can solve some of the most chronic clinical research problems. Digital technology is proving the antidote for high costs, slow timelines, poor patient experience, and uneven population representation across demographic groups. Here is the proof that we need.
Reducing costs & saving time
Common sense says that technology that enables more remote engagement would save both time and money, yet, the proof is in the pudding – or, in this case, the data.
According to a Tufts Center for the Study of Drug Development (CSDD) study, on average, decentralised trials can achieve net financial benefits from five to 13 times for Phase II and Phase III trials, equating to roughly $10 million and $39 million return on investment (ROI) for an investment on average of $500K in Phase II and $1.5M in Phase III trials, respectively.
Most of that financial return was the result of cycle time reductions. Nearly 85% of all clinical trials experience delay with a financial impact of an average of $500,000 per day (according to Tufts CSDD), but digitally enabled trials are shortening trial times. Next-generation AI is set to further shorten trial times by automating trial builds. Medable AI integrated in Medable Studio, for example, automates repetitive, time-intensive manual tasks to decrease time to First Patient In (FPI), dramatically accelerating study start-up. Building out multiple outcomes assessments for a study traditionally takes days, or even weeks, but can now be completed in 30 minutes, based on early metrics.
The Partnership for Advancing Clinical Trials (PACT) consortium in conjunction with the Tufts CSDD has also produced compelling results from a new study on 69 clinical trials that deployed decentralised elements and found that actual timelines beat planned timelines from first site activated to first patient enrolled, and from first patient to last patient enrolled. Actual timelines from first patient first visit to last patient first visit were, on average, 22.3 days shorter than the planned timelines. And mean actual timelines from protocol approval to database lock were 102.7 days shorter than planned timelines.
“Data completion rates were high across most usage and performance outcome variables – affirming the mission and viability of the consortium – and promising meaningful and actionable insights as the dataset continues to grow,” explained Ken Getz, Tufts CSDD executive director and research professor. “This study will become an invaluable source for granular data on the hybrid use and impact of individual DCT solutions and is already showing encouraging signs of the potential benefits of these technologies.”
Improving patient experience
Life sciences companies have historically struggled to improve the patient experience in clinical trials. According to Forte Research, the average dropout rate across all clinical trials is 30% and the average cost to recruit just one participant is $6,533. Retention throughout each phase of a clinical trial plays an important role in a study’s success, both from an economic and scientific point of view.
Despite the enormous impact that poor retention can make, a comprehensive study of more than 5,500 clinical trial participants conducted by the Center for Information and Study on Clinical Research Participation (CISCRP) in 2019, 2021, and 2023 shed some interesting light onto why retention is such a challenge. Participants face more onerous burdens in recent years. For example, in the 2021 survey, 44% of study participants indicated that travelling to a study clinic was “somewhat” or “very burdensome”, up 15% from just two years earlier. Additionally, the length of study visits was cited as “somewhat” or “very burdensome” by 40% in 2023 – nearly double what respondents indicated in 2021.
Remote participation in trials can have a major impact on patient experience. Specifically, enhanced eConsent solutions that incorporate digital elements (i.e., interactive videos, collapsible summaries, and knowledge checks) can help ease participation burdens.
Beyond eConsent, digitally enabled trials that leverage various tools for remote participation dramatically improve the experience, especially for patients with rare diseases. Christine Conlin, for instance, was diagnosed with Sjögren's syndrome, an autoimmune disease that caused her chronic fatigue to the point of desperation. After months of searching, Christine found a trial for Sjögren's hosted by the Tufts CSDD right in her backyard. Despite the proximity, commuting to and from triggered flare ups of her worst disease symptoms, so she was offered a remote alternative. Using a digital clinical trials platform, Christine only needed to visit a physical site once a month and log the rest of her data using a simple app on her phone. “This should be the standard of how trials are run. When people have a choice, the barriers to entry are nothing more than speed bumps,” said Christine.
Enabling population representation
Less than 2% of all US zip codes account for 50% of participation in FDA trials, and it is no secret that a significant discrepancy exists in how underrepresented patient populations are represented in clinical trials. To ensure appropriate safety and efficacy profiles of new drugs are established, they must be trialed on the same makeup of patients who will be using them in the real world once approved. It’s about science.
Digitally enhanced trials with more remote participation were expected to help dramatically improve patient access to trials, thereby improving population representation. But we didn’t have the evidence – until now. New data from the Tufts CSDD’s PACT Consortium links DCT/digital trial approaches to notably higher proportional representation among select demographic subgroups. The new research suggests that more strategic implementation of DCT approaches in conjunction with more rigorous planning can meaningfully improve diversity in clinical trials.
The analysis of 69 clinical trials showed that participants who identified as Asian comprised 20.9% of the total study populations when DCT components were deployed compared to only 14.2% when no solution was used. Proportional representation of indigenous communities (i.e., American Indian and Alaska Native) was nearly quadruple (1.9% versus 0.5%). Participation of women in DCT-enabled clinical trials was also significantly higher, at 55.7% vs 49.0%.
“The results show that DCT component use in clinical trials is associated with improvements in proportional representation by race and ethnicity, but there is still wide variation in patient preferences, by disease condition, and by the type of DCT component deployed,” said Getz. “Improvement in enrolment diversity and clinical trial access requires a very intentional and strategic approach. In a separate study, certain decentralised elements, such as local labs, were associated with significantly higher proportional representation among Black participants. As we collect more empirical evidence, it is very clear that one size does not fit all. Each clinical trial requires a custom approach driven by patient needs and preferences.”
Prove the value, now scale it
Historically, the life sciences industry purchases new technology incrementally at the study level and is frustrated with the lack of control and transparency with which the technology industry deploys these studies. Without the economies of scale, this approach often comes with higher service costs and slower innovation. Now, digital trial technologies are proving their value – garnering trust from large and mid-size life sciences companies alike. As evidence, Medable saw 80% revenue growth in 2024 across enterprise customers adopting portfolio-level electronic clinical outcomes assessment (eCOA) technology compared to study-by-study contracts.
The striking increase suggests rising industry confidence in the use of digital technology in clinical trials and a strategy shift from tentative, careful adoption to wide scale implementation across therapeutic areas, portfolios, regions, and even across the enterprise. Today, eCOA is foundational to technology-enabled trials and, by leveraging an SaaS model and shifting purchasing strategy, trial sponsors gain significant cost savings, operational efficiencies, and scalability.
From patients to sites, from small biotech to global pharmaceutical organizations – the confidence around digitally enabled clinical trials is skyrocketing. And it is no longer just the inflated excitement that helped the industry bridge the gaps during the COVID-19 pandemic. The technology works – now, it’s time to scale it.
To enable delivery at scale, organisations must diverge from the legacy, highly manual approach where each trial is treated as its own individual snowflake to a program approach with protocol-fit digital solutions that offer transparency and control. AI will be instrumental to enable automation while standardisation, common definitions, and global enterprise-level content libraries with reusable content will complete the scalability puzzle.
About the author
Andrew Mackinnon oversees the Medable Customer Value Team and leads product implementation to ensure that customers can successfully run efficient digitally enabled clinical trials. Mackinnon has more than 20 years of experience in managing clinical trials at large pharmaceutical, biotech, and CRO companies, most recently as a senior director in one of Covance’s therapeutic area delivery groups and as head of business performance. From his involvement in one of the earliest deployments of decentralised methodologies, he has been passionate about the benefits that this approach can bring in reducing the burden of clinical research on sites and patients and looks to leverage his broad operational expertise to improve how this approach is utilised globally.
