2025 Clinical Trial Trends
Clarkston’s team of life sciences consultants have highlighted the top clinical trial trends that businesses should consider. See an excerpt of the trends report below, and read all 5 trends for 2025 by downloading the full report here.
2025 Clinical Trial Trends
New technologies continue to drive innovative changes in the life sciences space, including clinical research. Transformations in data infrastructure, predominantly the shift from on-premises data storage to cloud-based systems, are pushing companies to reevaluate their data storage and processing systems to improve efficiency and expand their capabilities. While the uptick in decentralized clinical trials (DCTs) is not new, it is also indicative of this larger trend towards capitalizing on technological advancements in the virtual world. With this trend comes a push for Artificial Intelligence (AI), a tool that can streamline patient recruitment, improve the utility of real-world data, and increase the efficiency of the entire trial process. This is requiring companies to evaluate their current operating processes and is potentially revealing other areas for implementation projects to serve as steppingstones to effective AI use.
Clinical trial organizations need to be able to quickly pivot and adapt to changing circumstances, the globalization of the market, and changes in the collaborative elements of clinical research. Adapting requires moving away from the traditional clinical trial process to a leaner and more cost-effective model. Increasing diversity and representation within trials remains a priority going forward, and change is coming as regulators are more amenable to considering new ideas and innovations and as sponsor companies are brave enough to think outside the box and embrace a new way of doing clinical trials. In this report, we outline these trends and highlight their impacts on the clinical trials industry going into 2025.
Trend #1: Modernized Data Infrastructure
The clinical trials space is no exception to the plethora of benefits introduced by the implementation of cloud-based data platforms, including Software as a Service (SaaS) systems. Switching to the cloud can produce cost savings, expedite trials, improve data security, make data storage more efficient, and allow better access to real-time data. The shift toward the cloud has pushed leading suppliers of SaaS systems to expand their portfolios to explicitly support clinical trials, offering tools including trial management, payments, site connection, and training.
Change is a key factor with cloud-based service, and although it does require an upfront investment in underlying services, application remediation, and building new organizational capabilities, the ROI will soon be met as companies are able to complete the phases of a digital transformation faster and more efficiently. Clinical trials organizations also need to work to ensure that stakeholders are prepared for these changes to prevent the all-too-common failure of a system due to poor user adoption. Throughout an implementation of a new cloud-based service, it is important to keep stakeholders informed and involved and ensure proper hands-on training and preparation of end users.
Many companies, especially in the cell and gene therapy industry, are increasingly outsourcing clinical research, creating issues with the aggregation of information and data from a variety of organizations and sources. Switching to cloud-based data storage can help mitigate these issues by establishing a central repository in which to store data from several sites. Additionally, some vendors offer analytics services to standardize and present data, further aiding in the integration, sharing, and analysis of the data gathered in the clinical research process.
With the uptick in the use of cloud-computing across all industries, the implementation of cloud-based services becomes more and more advantageous due to the benefits of integration with other platforms. Cloud-based data storage opens doors to integration and collaboration as well as the implementation of Artificial Intelligence tools to streamline activities in every part of clinical trials.
Trend #2: Integration of AI: Distinguishing Utility from Fad
Artificial Intelligence (AI) has applications in virtually all spaces of clinical trials and is undeniably beneficial when implemented and applied appropriately. Its future success will rely on real, specific applications. It is vital to approach the implementation of AI strategically and with great care to prevent wasting time and resources without thinking of long-term sustainability.
For clinical research, AI can expedite trial design and patient recruitment and aid in data management. A computer scientist at the University of Illinois Urbana-Champaign developed algorithms to predict trial success and prioritize more recent trials for cross-referencing data. This can save time by reducing the manual efforts usually required by these tasks. In another example, a group at Stanford developed Trial Pathfinder, an AI system which suggests ways to adjust participation criteria to expand the number of eligible patients without increasing the hazard ratio for a trial. These examples illustrate targeted applications of AI that prove successful in achieving specific results. Research organizations do not need to bring on teams to develop AI programs internally. There are also software companies that can be brought on specifically to leverage AI to achieve an organization’s goals.
It is important to evaluate business needs for AI implementation; within a given organization, there will be no one-size-fits-all solution. Clinical research organizations must consider which parts of their processes can stand to benefit from AI solutions and how best to implement them. Additionally, despite common misconceptions, AI is simply a tool for researchers, not a replacement. To make efficient use of it as a resource, proper training procedures must be created to effectively eliminate excessive manual processes and ensure accurate results. AI cannot operate independently, and it is also necessary to ensure that proper systems are in place to perform quality checks and protect sensitive information. Continue reading by downloading the full report below.
Download the Full 2025 Clinical Trial Trends Report Here
Read last year’s Clinical Trial Trends Report here.
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Contributions from Sydney Epps