Clinical Trials in 2024 - Are We Making the Grade?

Clinical Trials in 2024 - Are We Making the Grade?

This article is based on the session titled, “The State of Clinical Trials in 2024: Are We Making the Grade?” at the DIA 2024 Global Annual Meeting, in San Diego, June 2024. Many thanks to the presenters: Summer Starling (CTTI), Jennifer Miller (Yale School of Medicine), and Linda Sullivan (Tufts Center for the Study of Drug Development) for their valuable insights. This translation is the author’s rendering of their points and should not be taken as exact quotations. 

In 2024, the clinical trials landscape is undergoing significant transformation. To gauge our progress and effectiveness, we must scrutinize the metrics and measurements driving clinical trial innovation and performance and get a handle on the enormous amount of data being generated. When the audience was polled, diversity, cost, and efficiency top the list of what comes to mind when thinking about measuring progress and improvements in clinical trials. While understanding impact and sharing meaningful results topped the audience list for what is the biggest change to implement for pursuing metrics and measurement in clinical trials. 

Linda Sullivan, from the Tufts Center for the Study of Drug Development, emphasized clinical trials are generating unprecedented amounts of data. This deluge raises critical questions about which data to prioritize and how to derive meaningful insights.  

One of Halloran’s key consulting services is tied to proactive planning to prepare your organization for evolving regulatory requirements impacting data integrity by implementing scalable data oversight processes, procedures, and governance to minimize risks. Our training programs aim to ensure your teams are equipped with the latest industry knowledge to strengthen your organization’s ability to handle the data deluge referenced in this session.  

Clinical Trials Transformation Initiative (CTTI) 

CTTI provides a strategic vision for transforming the clinical trials landscape by 2030. Their vision offers a comprehensive framework to measure and guide global clinical trial progress. CTTI has identified eight pillars essential for understanding and advancing clinical trial performance. These pillars serve as the north star, with each domain containing three specific metrics, culminating in 57 metrics to measure success across 19 domains.  

Pillars include patient-centered methodologies, improving access, full integration into health processes, designed with a quality approach, leveraging all available data, and improving population health.  

Innovative trial designs, such as pragmatic trials, simulations, and adaptive designs, are crucial for balancing innovation with practical applicability. Access to high-priority metrics necessitates exploring data collaborations, and socializing and publishing findings for public input is vital for refining and validating clinical trial approaches. This inclusive strategy seeks opinions and reactions to ensure comprehensive understanding and acceptance of clinical trial transformations. 

Linda Sullivan reminded the audience that the focus shifts to the messages conveyed by an organization’s metrics. Metrics should establish priorities, influence behaviors, and clarify what actions are rewarded or overlooked. This ties into the broader question of whether we are effectively measuring the right things and defining success appropriately. The metrics must help answer key questions, define acceptable standards, and motivate performance through effective communication. 

Organizations often focus on tracking issues rather than celebrating successes. Improving metrics involves not just highlighting what is going well but also showcasing where there are improvements to be made. This dual approach—akin to a good pharmaceutical scorecard—can spotlight positive frameworks and encourage transparency and accountability. The Good Pharma Scorecard, for instance, grades pharmaceutical companies on their performance and transparency, providing a model for clinical trial metrics.¹ 

Setting achievable performance targets and celebrating milestones is essential. Diversity in clinical trials remains a challenge, and realistic goals are crucial for making meaningful industry-wide progress. By refining our metrics, fostering innovation, and maintaining clear communication, we can ensure that clinical trials continue to evolve and improve, ultimately benefiting patients and advancing clinical research. 

Take a Stand 

What are you doing to advance clinical trials this year and beyond? Consider attending Halloran’s Clinical Operations Retreat for Executives (CORE) conference, October 16-18, 2024. CORE is an event designed for like-minded clinical operations executives and senior leaders in life science to talk through the most pressing issues around product development and building companies in this industry. Let’s continue the conversation and keep innovation at the forefront. To learn more, register here. 

Reference: 

1. Bioethics International. Good Pharma Scorecard. https://bioethicsinternational.org/good-pharma-scorecard