How To Measure ROI in Decentralized Clinical Trials

At the 2024 DPHARM conference, Ken Getz, Executive Director and Research Professor at Tufts Center for the Study of Drug Development (CSDD), provided a comprehensive exploration of the complexities involved in measuring Return on Investment (ROI) in decentralized clinical trials (DCTs). His presentation highlighted the critical role of financial metrics in driving the adoption of innovations within the pharmaceutical industry, offering a detailed analysis of both short-term and long-term ROI. Getz’s insights underscored the importance of understanding ROI as a persuasive tool for senior management and corporate decision-makers, emphasizing its impact on portfolio management, resource allocation, and capital investment.

Understanding ROI in Clinical Trials

Ken Getz’s presentation delved into the multifaceted concept of ROI within clinical trials, mainly focusing on decentralized clinical trials. He emphasized that ROI is not merely a financial metric but a critical language that resonates with senior management and corporate decision-makers. This language is essential for influencing decisions related to portfolio management, resource allocation, and capital investment. Understanding ROI is crucial for those involved in developing and promoting innovations. It serves as a persuasive tool to drive the adoption of innovations by demonstrating their financial viability and potential benefits. Getz explained that a broad spectrum of methods is available to gather economic data that informs ROI. On one end of the spectrum are qualitative measures, such as patient stories and direct experiences, which can be powerful in persuading stakeholders. These narratives provide a human element that can highlight the real-world impact of innovations. On the other end are quantitative measures, often seen as business’s ultimate language. These include detailed financial analyses and metrics that provide concrete evidence of an innovation’s value. Quantitative measures are particularly effective in gaining traction within organizations, as they offer a clear and objective assessment of financial performance.

The Role of Expected Net Present Value (ENPV)

Much of Getz’s presentation explained the concept of expected net present value (ENPV) modeling. This approach is widely used in the pharmaceutical industry to assess the financial value of a drug development program. ENPV involves comparing the commercial performance of a drug against the costs invested in its development, both with and without the benefit of an innovation. Getz highlighted that ENPV is a comprehensive model that considers multiple scenarios, including success and failure, to provide an average expected outcome. He elaborated on the process of ENPV modeling, which involves discounting future commercial inflows to present-day dollars and inflating the costs to reflect their present value. This allows organizations to assess the net financial value of a program over its entire lifecycle. Getz provided examples of how ENPV modeling can be applied to decentralized clinical trials, illustrating the potential financial benefits of adopting virtual and remote solutions in clinical trials. He noted that this approach is particularly valuable for evaluating the impact of innovations, as it provides a clear comparison between traditional and innovative trial designs.

Economic Context and Its Impact on ROI

Getz also discussed how economic conditions influence the focus on ROI within the pharmaceutical industry. He explained that in periods of strong economic growth, organizations tend to emphasize long-term financial value through ENPV modeling. This is because robust capital markets and strong market demand create an environment where long-term investments are more viable. In such times, companies are more likely to focus on their programs’ expected net present value, as it provides a comprehensive view of financial value over time. Conversely, there is a shift towards short-term performance outcomes in challenging economic environments, such as the current global economy. Getz noted that in periods of economic uncertainty, organizations prioritize metrics like speed, quality, and cost at the clinical trial level. This shift reflects the need for immediate results and cost-efficiency in a softer economic environment. Getz provided examples of how short-term ROI measures can be particularly valuable in times of high inflation and reduced commercial performance, as they offer a more immediate assessment of an innovation’s impact.

Data-Driven Insights and the PACT Consortium

In his presentation, Getz introduced the PACT (Platform for Accelerating Clinical Trials) consortium, a collaborative effort to gather more granular data on the impact of DCTs. He explained that the consortium was established to address the need for better data on the effectiveness of virtual and remote solutions in clinical trials. In its first year, the consortium included 30 member companies, each contributing to collecting data on clinical trials. Getz highlighted the importance of establishing consensus definitions and collecting hard data to ensure consistency across the industry. Preliminary findings from the consortium revealed a growing understanding of hybrid and customized approaches specific to trials and diseases. The data collected by the PACT consortium offers valuable insights into the effectiveness of various DCT elements, providing a foundation for future research and innovation. By leveraging this data, companies can optimize their use of DCTs, ensuring they are implemented effectively and efficiently. The consortium’s efforts to gather more granular data will play a crucial role in overcoming challenges and optimizing the use of DCTs in the pharmaceutical industry.

Challenges and Opportunities in Decentralized Clinical Trial Adoption

Despite the promising potential of decentralized clinical trials, Getz acknowledged several challenges organizations face in adopting these innovations. He noted that the lack of ROI measures has led some companies to reconsider their rapid adoption of DCT solutions, particularly in the wake of the pandemic. This decrease reflects the need for clear financial metrics to justify the investment in new technologies. Getz also highlighted the mixed reports from organizations implementing virtual and remote solutions. While some companies have seen positive results, others have encountered challenges related to their collaborators’ preparedness and the marketplace’s capacity to provide scaled solutions. Investigative sites, in particular, have reported feeling burdened by the need to support these solutions without adequate support. Despite these challenges, Getz expressed optimism about the future of DCTs. He emphasized the importance of continued data collection and analysis to refine the understanding of these innovations and their impact on clinical trials. The PACT consortium’s efforts to gather more granular data will play a crucial role in overcoming these challenges and optimizing the use of DCTs in the pharmaceutical industry. By addressing these challenges, companies can unlock the full potential of DCTs, transforming clinical research and improving patient outcomes.

Conclusion

Ken Getz’s presentation at the 2024 DPHARM conference underscored the importance of robust ROI measurement in adopting decentralized clinical trials. By leveraging data-driven insights and collaborative efforts like the PACT consortium, the pharmaceutical industry can better understand the financial impact of innovations and optimize their implementation. As the dataset grows, Getz expressed optimism about the future of decentralized clinical trials and their potential to transform clinical research.