From the Archive: 6 Takeaways of DPHARM 2024 Keynote, Tufts’ Kenneth Getz, on Measuring DCT Return on Investment

“Return on investment is the language of senior management,” said Kenneth Getz, MBA, Executive Director & Professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine. “It’s an extremely important way that we persuade and ultimately drive adoption.” 

For those who are making the case for investment in new innovative tools and approaches for decentralizing aspects of clinical research, it’s critical to measure and communicate the financial return in order to persuade senior leadership and solidify organizational support. 

Below are key takeaways from Mr Getz’ presentation on how to measure and convey value: 

1. Measure ROI in the Short-Term and Long-Term

Mr Getz broke down ROI into two streams: short-term and long-term. Short-term ROI is a more immediate focus because of the challenging current economic environment, and details the impact on immediate trial performance outcomes, including speed, quality and cost. “Time is really the critical driver in short-term ROI,” said Mr Getz, 

Long-term ROI, which Mr Getz quantified with expected net present value (ENPV), looks at the entire development and commercialization of a program. ENPV takes into account the development cycle’s duration, the success rate, sales and market exclusivity, and models scenarios both with and without an innovation, like a DCT. The difference in value represents the financial return created by applying that innovation. 

2. Use the Expected Net Present Value Model to Show Overall Impact

The initial model from 2020 that Mr Getz referenced was focused on oncology trials, using benchmark data from 33 trials conducted just before the pandemic that had one or more virtual/remote elements. Mr Getz noted that the sample was limited in scope, and the study also utilized data from Medable and estimates from Medable on the average investment required at each phase. 

The findings were that with a deployment investment of $1.9 million, the base case saw a reduction of three months in a Phase II cycle time. That translated into a 5x return on investment, roughly $9 million in value creation. The change for Phase III was even larger: deployment investment of $3.1 million, a three-month time savings, and a net financial impact of $41.2 million compared to benchmark. Mr Getz noted that the financial impact change in growth from II to III was given to the size and scope of those programs. 

““Return on investment is the language of senior management. It’s an extremely important way that we persuade and ultimately drive adoption.” 

3. Most Common Areas of DCT Usage, according to PACT Consortium Data

The study highlighted the need for more actual data, leading to the formation of the PACT (Partnership for Advancing Clinical Trials) Consortium, spearheaded by Tufts, Medable, Regan-Udall Foundation. The goal is to gather more granular, actual data and be able to look at the impact of individual solutions, by disease condition, by phase, etc. In the first year, 30 companies joined and Mr Getz shared data submitted by its member organizations from nearly 70 clinical trials. 

The companies involved in the PACT consortium all anticipated that they would be applying DCT elements to 45% of their trials within a five-year-period, but all were encountering challenges in doing so. That included not having a measurement for ROI, which led to a retreat from rapid DCT adoption, as well as mixed reports from using virtual/remote solutions, scaling and capacity, site adoption, and more. 

With the caveat that only 17% of the trials were complete, Mr Getz shared the following key learnings. The most common area of deployment for virtual/remote solutions was during the study visit, with an average of 3 solutions. There was a broad range, but the 5 most commonly included eCOA, apps for patient reminders and data collection, home visits, and telehealth or video. 

“We’re seeing some indications that organizations have access to the data much faster when a virtual or remote solution has been integrated.” 

4. Expectation vs Reality for Cycle Time with DCTs

When it came to performance outcomes, even with a limited sample size of trials using DCT elements/components, the data showed the actual timeline came close or beat the planned timeline. Mr Getz noted that a flaw with the methodology was that many organizations, because they have limited experience with DCT, might take longer to plan. The data would continue to evolve as more companies contributed and as more companies became more familiar with DCTs. 

However, despite the expectation from some organizations that the inclusion of a DCT element would extend cycle times or cause delays, Mr Getz noted that there was no significant differences. There were slightly longer startup and initiation cycle times, but the virtual/remote component helped to catch up once the trial was underway. “We’re seeing some indications that organizations have access to the data much faster when a virtual or remote solution has been integrated.” 

5. Demographic Representation 

Mr Getz pointed out that from the data being collected on demographic representation, it showed there was a higher representation of women and Asian patient communities in trials that involved DCTs, and another study indicated that local labs, local locations and specialty locations contributed to higher representation in clinical trials. 

“This particular output, which we will be able to update over time with more data, helps inform our understanding of changes and shifts in diversity representation,” said Mr Getz. 

6. The Cost of a Day’s Delay in Clinical Development

The cost of a day to run a clinical trial is an important measure that can be used to determine the value of short-term ROI. According to a study published around the time of Mr Getz’ presentation, the cost of a day’s delay in prescription drug sales was roughly 25% of what it had been in 1992-1999. In today’s market, an increasing share of the portfolio is made up of drugs targeting rare/ultrarare diseases in narrow patient populations. That means that expected net present value must be evolved to account for today’s environment. 

Conversely, the daily cost to run a clinical trial has not kept pace with inflation. Many sites are finding that many procedure costs have declined over time but are being asked to do more with limited/constrained budgets. 

For more information about the upcoming 2025 DPHARM: Disruptive Innovations to Advance Clinical Research program, go to DPHARMconference.com.

Kenneth Getz, MBA

Executive Director and Professor

Tufts Center for the Study of Drug Development

Kenneth Getz, MBA

Executive Director and Professor
Tufts Center for the Study of Drug Development

Kenneth A. Getz, MBA, is the Executive Director and Professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine, where he conducts research focusing on drug development management and operating strategies and tactics; protocol design practices; and global outsourcing, investigative site and patient recruitment practices and policies. He is also the chairman of CISCRP – a nonprofit organization that he founded to educate and raise public and patient awareness of the clinical research enterprise. A well-known speaker at conferences, symposia, universities, investor meetings and corporations, Mr Getz has published extensively in peer-review journals, books and in the trade press and writes a bi-monthly column nominated for a Neal Award in Applied Clinical Trials. He holds a number of board appointments in the private and public sectors including WCG and ORA and serves on the editorial boards of Pharmaceutical Medicine and Therapeutic Innovation and Regulatory Science.  Mr Getz received an MBA from the J.L. Kellogg Graduate School of Management at Northwestern University and a bachelor’s degree, Phi Beta Kappa, from Brandeis University. Mr Getz is the founder of CenterWatch, a leading publisher in the clinical trials industry.