4 Steps To Make A Business Case For Digital Endpoints
By Anita Burrell, principal, Anita Burrell Consulting LLC
Digital biomarkers and endpoints are increasingly used in clinical development and have gained acceptance from regulatory authorities. In fact, to date, 97 digital endpoints have been in Phase 3 studies and nine have been used as primary endpoints in Phase 3 studies by seven different manufacturers, according to the Digital Medicine Society (DiME) open-source Library of Digital Endpoints. Across all stages of development, 129 digital endpoints have been noted as primary.1 Their use is compelling, considering R&D costs have risen to an average of $2.23 billion per asset in 2024.2
Although they have huge potential to improve trial operations, digital endpoints often require an up-front investment to ensure they can be implemented effectively. This article details the steps needed to build a business case for their inclusion and the elements to consider, using examples from literature.
How Can I Build A Business Case For Digital Endpoints In My Study?
DiME3 has several excellent resources to help researchers identify the value of incorporating digital endpoints as well as ensuring that these are analytically and clinically validated measures designed with regulatory or reimbursement in mind. The value of including a digital endpoint will differ depending on the therapeutic area and the clinical development stage, as well as other factors, such as the intended use of the digital measure.
1. Identify The Value Proposition
The Digital Endpoints Value Framework4 describes four reasons for including a digital endpoint and offers specific aspects that can be improved through these measures. Digital endpoints might first be used in screening to facilitate faster recruitment by conducting remote identification of eligible participants, finding more representative patient populations, and/or offering improved sensitivity in identifying the target population due to more frequent measurement when compared to traditional endpoints.
Continuous real-time monitoring of early safety signals is another area where digital endpoints can offer advantages over traditional endpoints. For example, smart devices, including but not limited to KardiaMobile, Apple Watch, CardioSkin, BodyGuardian, and ECG Check, measure QT intervals.5 The gold standard for QTc analyses is the 12-lead ECG, which requires a clinic visit, but smart watches and smart devices allow patients to record an ECG without traveling to a clinic and do so more frequently. While a device should be fit-for-purpose, the advantages of improved adverse event management, in this case for heart rate abnormalities, are a clear value driver for digital endpoints.
A third possible use case is to detect early proof of efficacy, to unearth confirmatory evidence, or to provide real-world insights. Digital endpoints allow researchers to detect treatment effects earlier or identify subtle signals, which can reduce the sample size required and the trial time needed to show an effect.
Finally, in the post-approval stage, digital endpoints can help collect evidence for additional label claims, such as new indications, or to inform market access and reimbursement decisions. In each case, DiMe’s Digital Health Measurement Collaborative Community Value Framework outlines conditions to be met and provides supplemental information.
2. Establish The Budget
Once the value drivers are established, the business case for endpoints must provide a detailed breakdown and comparison of the costs for both digital and non-digital approaches. As noted by the business case template, this should “provide a clear and realistic estimate of the financial resources required to implement digital endpoints in your clinical trial.”
The key cost categories include the technology itself, as well as the wearable, sensor, or tool, and any licensing fees and software needed for data collection, storage, and analysis. Data management and integration costs, such as validation costs, system integration with existing trial infrastructure, and cloud storage and cybersecurity considerations, should also be anticipated.
Other notable cost categories include third-party vendor costs for devices and support, as well as external consulting for regulatory strategy, validation, and implementation; operational and training costs; and compliance and regulatory filing preparation. The template suggests providing an estimated cost per unit (e.g., per trial participant, phase, or device) in each of these areas, the total projected costs, and the division between capital expenditure versus operating expenses to calculate the difference between digital and non-digital approaches, including highlighting cost savings.
3. Calculate The Projected Return On Investment
A key part of the business case is providing the expected net present value (eNPV) and return on investment (ROI) calculations for digital endpoints; the aforementioned resources include a reference guide6 and an online ROI calculator. The calculator is based on the model developed by diMasi et al (2024, a collaboration paper between DiME and Tufts Center for the Study of Drug Development, which illustrated the potential returns using evidence-based sources relating to revenue forecasting, costs of trials and marketing efforts, trial size, and trial length).
The model calculates the eNPV by estimating the revenue and costs of a program each year for digital and non-digital approaches, weighting them by the probability of success, and discounting based on the cost of capital. If the model shows a strong positive impact, it suggests that digital endpoints could make drug development more cost-effective.
The ROI is calculated as the ratio of the estimated increment in eNPV by using the digital endpoints to the mean cost of implementing the digital measure. If the result is a positive ROI, it suggests that digital endpoints provide financial value beyond their cost. If the ROI is negative, it indicates that the investment may not be justified based on current conditions.
4. Anticipate Risks And Barriers
The template provides examples of challenges to implementing digital endpoints and encourages researchers to think through mitigation efforts. It notes that this “demonstrates proactive risk management and strengthens your business case.” Potential risks and barriers could exist in terms of regulatory acceptance, data reliability, site adoption, patient engagement, and/or budget constraints, among others. A final section showcases successful real-world examples so researchers can choose case studies that are in a similar disease area and/or have used comparable endpoints or devices.
Final Thoughts On Digital Endpoint Integration
The steps outlined above provide a systematic approach to building a business case that can justify the cost outlay required to include the digital endpoints in clinical studies. Including digital endpoints has been shown to reduce sample sizes, shorten study timelines, and reduce costs. By following the DiME template, researchers can add to the case studies of successful implementation, such as the use of digital multimodal speech biomarkers in amyotrophic lateral sclerosis, which have proven stable and responsive enough to allow signal detection in samples of only 15 patients.7 Whether a business case results in reduced trial durations from remote data collection on an ongoing basis or yields a reduced burden on trial participants while facilitating a more diverse population and accelerating recruitment, following the template to provide a rational and compelling argument will increase the likelihood of success.
References:
- https://dimesociety.org/library-of-digital-endpoints/ accessed August 30th, 2025
- https://www.deloitte.com/us/en/Industries/life-sciences-health-care/articles/measuring-return-from-pharmaceutical-innovation.html
- https://dimesociety.org/access-resources/
- https://datacc.dimesociety.org/building-the-business-case-for-digital-endpoints/value-framework/
- Hoek L et al Frontiers in Cardiovascular Medicine 2023, https://doi.org/10.3389/fcvm.2023.1172666
- https://udxufgxkxmv8-u4418.pressidiumcdn.com/wp-content/uploads/2025/03/Digital_Endpoints_ROI_Calculator_Reference_Guide.pdf
- Neumann M et al, Computers in Biology and Medicine 2024, 108949 https://doi.org/10.1016/j.compbiomed.2024.108949
About The Author:
Anita Burrell has over 23 years of pharmaceutical industry leadership experience in the UK, France, and the U.S. in a variety of roles. She led global pricing and reimbursement for Sanofi, directed the development of Aubagio (an oral MS therapy), and was the head of strategic commercial excellence. As the principal of Anita Burrell Consulting LLC since 2015, Anita helps companies understand market dynamics and payer behavior, design integrated evidence plans and value communication projects, as well as understand the implications of digital health and possibilities to use behavioral economics. Anita served on the Healthcare Businesswomen’s Association Global Board of Directors and is the past chair of the ISPOR Digital Health SIG, which addresses opportunities in the healthcare sector emerging from the increasing use of digital technologies. Anita holds a BA (Hons) in economics from the University of Stirling, an MA in economics from Dalhousie University, and an MBA from Kingston University.