Shorter, Faster, Cheaper: Powerful New Data On Digital Endpoints
By Sarah Valentine, partnerships lead, and Bert Hartog, VP of sustainability and transformation, Digital Medicine Society (DiMe)
Over 80% of studies fail to enroll on time. With the clinical trials market anticipated to grow at a compound annual growth rate of 7.07%, and with trial sponsors already struggling to recruit and retain participants in such a complex and competitive research environment, our industry, which patients depend on to bring new lifesaving and life-changing drugs to market, is on a dangerous trajectory. This much is evident from the sheer number of layoffs, reorganizations, and restructuring efforts we’ve seen in the past year alone. To combat these very real risks, clinical trial executives across the life sciences industry continue to search for new and inventive ways to reduce enrollment and study timelines, and leading researchers are conducting groundbreaking research to demonstrate potential value creation and cost reduction strategies.
Enter digital endpoints.
The idea of leveraging novel, sensor-based measures to gather data for clinical trials is not new, with the first trial reporting a digital endpoint dating back to 2005. Since then, the adoption of digital endpoints has grown rapidly, as evidenced by DiMe’s Library of Digital Endpoints. In 2019 when the library was first established, it contained only 34 unique endpoints. Today, that number stands at 422 — a 1,141% increase.
Many innovators began to hypothesize that digital endpoints not only provide an unprecedented view into patients' true lived experiences over time, but with the added richness of data collected using sensor-based digital health technologies, digital endpoints may allow sponsors to conduct trials with fewer participants over shorter durations.
Sure, the idea is compelling, but where’s the evidence?
As an industry renowned for its quality and rigor, the proof is in the pudding and so far, the pudding… hasn’t existed. There have been individual success stories, to be sure — Roche, Lilly, Verily, Bellerophon, and others have produced significant case studies that illustrate reductions in study duration and enrollment with the advent and application of digital endpoints — but a field-wide examination of the benefits, costs, and return on investment associated with digital endpoints has not been undertaken - until now.
Examining The Evidence
The Tufts Center for the Study of Drug Development recently partnered with the Digital Medicine Society (DiMe) along with industry leaders from J&J, Roche and Genentech, UCB, Bayer, Takeda, and Mindmed to conduct a study looking at evidence found in the ClinicalTrials.gov database to determine the true value of digital endpoints. The results, recently published as a preprint, indicate that digital endpoints can lead to significantly reduced enrollment and trial timelines, resulting in three- to four-month reductions in Phase 2 trial duration and four- to five-month reductions in Phase 3 trial duration.
The authors also evaluated the costs of developing and implementing digital endpoints. As anyone who has deployed these new capabilities knows, digital endpoints aren’t known for being cheap, and the data gathered and presented in the preprint illustrates this. However, the manuscript not only reports the average costs of digital endpoint implementation but also employs an expected net present value (eNPV) model to contextualize the benefits and costs associated with digital endpoints.
The results of the eNPV model are even more compelling. In Phase 2 studies, digital endpoints are associated with an increase in value of $2 million to $3 million. In Phase 3 studies, the eNPV grows to $25 million to $48 million, increasing the return on investment by four to seven times.
Though digital measures and endpoints have existed for quite some time, the clinical trials enterprise has yet to fully capitalize on the true value that these measures promise to deliver. With the current pressure to reduce spend and increase clinical trials' efficiency, this first-of-its-kind research is timely. Could digital endpoints provide a new way forward for clinical researchers to weather the current challenging economic and research climate? This new evidence suggests that the answer is yes.
The Way Forward
To further increase the value of digital endpoints, the bottom line is this: We have to reduce the bottom line. In addition to reducing the costs of digital endpoints, organizations should also look for ways to share the costs and risks of developing the measures that underlie these endpoints. Collaboration in the development of digital endpoints can spread both cost and risk to further increase time to value and absolute value for every organization involved.
Organizations like DiMe, the Critical Path Institute (CPATH), and the Foundation for the National Institute of Health (FNIH) convene industry leaders to develop digital measures, with groups like the Digital Endpoints Ecosystem and Protocols (DEEP), Duke’s Big Ideas Lab, and Sage Bionetworks going a step further to establish shared algorithm assets to enable faster and more affordable measure development. These forums are an important starting point for R&D teams looking to maximize each dollar they spend.
In particular, DiMe’s next project will build on the findings of this study to further quantify the value of digital endpoints. This upcoming effort will focus on the development of a value framework along with benchmarking and forecasting tools to support further data-driven investments in these innovative digital capabilities.
About The Authors:
Sarah Valentine leads partnerships across life sciences at the Digital Medicine Society (DiMe). In her role, she thinks critically about the challenges we face in drug development and commercialization to drive strategy, prioritization, and concept development across areas of unmet need where there's opportunity at the intersection of healthcare and technology to deliver unprecedented value to patients and other stakeholders across our industry. She convenes teams of interdisciplinary thought leaders and subject matter experts to tackle some of the biggest challenges we face as a field in order to advance the ethical, effective, equitable, and safe use of digital medicine to redefine healthcare and improve lives.
Prior to her role at DiMe, Sarah was a digital implementation lead at Eli Lilly & Company, where she led efforts at the intersection of clinical development and digital health to leverage innovative digital technologies including digital measures, combination products, and other DDTs in clinical research.
Bert Hartog, MSc, PhD is an international industry expert in clinical research and digital health. He graduated in medical biology and obtained a Ph.D. in medicine from Utrecht University. He held management positions in clinical operations, quality assurance, and IT at Eli Lilly and Johnson & Johnson.
In the last 10 years, he has focused on patient-centricity, designing solutions based on robust science to optimize the patient experience in clinical trials. He augmented this with digital health, developing solutions for disease characterization and remote monitoring.
Bert is co-founder of a tech startup that standardizes the development and qualification of digital measurement solutions and drives harmonization of digital measures. He also studies the environmental impact of clinical research and digital technologies, looking for ways to reduce e-waste by bringing circularity into digital health, which resulted in the EU-funded program DiCE that launched in October 2022. In early 2024, he left Johnson & Johnson and joined the Digital Medicine Society (DiMe) as their interim VP for sustainability & transformation.