DPHARM 2024: Analyzing DCT Deployments
Session reveals how organizations can implement DCTs into their clinical trial planning and execution processes.
One of the first presentations to kick off DPHARM 2024 (following the patient keynote) was hosted by Ken Getz, executive director and research professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine, centered around “Examining Short and Long-Term ROI of DCT Deployments.”
Getz noted that ROI—or return on investment—is “an extremely important way that we [the industry] persuade and ultimately drive adoption,” in essence, it serves as a way to entice the adoption of an innovation.
His objectives heading into the presentation were to review the past research that measured the short and long term ROI of DCT (decentralized clinical trial) deployments; discuss the on-going techniques that organizations are employing in order to incorporate DCTs into their clinical trial planning and execution processes; and share results from the PACT Consortium, which is essentially a collective of 30 sponsors and contract research organizations who have shared metrics for benchmarking DCT use and impact.
Short-term vs. long-term quantitative ROI assessment
In a nutshell, Getz explained that short-term ROI, is arguably the most meaningful measure today. It's most commonly used for clinical trials during periods where the economy is more challenged—particularly in a softer economic environment—and could be represented by periods of high inflation. However, it’s limited by being narrowly focused, and the fact that it only measures point-based effects.
On the other hand, long-term ROI is utilized in the opposite climate: a robust financial environment, measured during program development.
What is eNPV modeling?
eNPV modeling—short for expected net present value—is a long-term financial technique used to measure investment value, specifically pertaining to technical, operating, and regulatory risk. It’s run by many major pharma and mid-sized pharma companies, mapping out the outflows (all of the program development costs) and inflows (commercialization revenue).
This model, Getz added, “looks at multiple scenarios, some where a drug will fail, others where it will succeed, and the expected net present value is the average for all of the outcomes in the model.”
And according to Tufts CSDD studies, a Phase III program’s probability of achieving approval is 56%, with with an average overall direct clinical phase cost of $285 million. For additional perspective, Cortellis, Adis Insight data revealed that it takes an average of 10 years for a company to achieve peak sales, which, at the point, could potentially reach a mean of $1.8 billion.
Introducing the PACT Consortium
As alluded to above, this collective provides actual DCT use and performance outcomes data from recent clinical trials. It was launched summer 2023, receiving funding from both the Regan-Udall Foundation and Medable.
In the first year alone, members have established governance, define consensus definitions so that they are all on the same page in terms gathering and measure the same qualities, including data on the demographic representation of patients enrolled in the studies that needed to be gathered properly.
For year two, the goals revolve around scaling the data set and conducting much more granular analysis.
Reference
Getz K. ROI Keynote: Examining Short and Long-Term ROI of DCT Deployments. September 17, 2024. DPHARM 2024. Philadelphia.
