2025 Clinical Trials Outlook: Six industry trends to expect

Rising costs, shifting regulations, and the surge of artificial intelligence (AI) have been hot topics in the industry this year and are trends that will continue into 2025. At Velocity, we’re bracing for a year defined by technology-driven efficiencies, an increased emphasis on multisite networks, and lingering regulatory uncertainties.

1. Rising costs will drive efficiency 

Research and development cost pressures are ongoing in pharmaceutical development and will facilitate the need for more efficiency throughout the value chain. Technology, particularly AI, offers a solution to reducing costly administrative burdens, recruiting and retaining participants, and enhancing data quality. It will be essential for streamlining drug development throughout 2025 and beyond. 

This year, Velocity demonstrated the benefits innovative technology can deliver for clinical trials with the launch of our technology platform, VISION. It has two distinct applications: VISION Recruit and VISION Engage. 

VISION Recruit is designed to improve the patient experience, increase efficiency, and accelerate recruitment. In its first year of use, Recruit sped up prescreening by 650%. The second application, VISION Engage, is a user-friendly mobile app that connects patients to trials. 

Dr. Gregg Lucksinger from Velocity’s Austin site noted, “Whenever I see a new subject, I ask how they found out about us. Traditionally, it’s been online or through social media, but now more participants say they learned about trials through the app. It’s a great resource, particularly for those who like to do trials.”

1. The role of site networks will continue to expand 

Sponsors and CROs increasingly favor site networks. The L.E.K Clinical and eClinical Pharma Survey showed that utilization of site management organizations (SMOs) across Phase 1, 2, and 3 trials has grown significantly over the past few years, with 21% of P3 trials often or regularly using SMOs in 2023, compared to just 15% in 2021. 

Working with multisite networks simplifies trial management for Sponsors and CROs. They can engage one entity to manage multiple locations, often with a single project manager overseeing the trial for the network. This centralized model accelerates trial startup times, facilitates shared learning between sites, and gives Sponsors and CROs the benefits of specialist tools like VISION, which deliver an engaged and highly targeted patient population — advantages that will prompt increased use of site networks in clinical trials. 

1. New players will emerge as the industry matures

The growing interest from Sponsors and CROs in engaging network organizations has already prompted consolidation of site organizations, with independent sites becoming part of owned networks. 

Similarly, we expect to see merger and acquisition activity amongst existing networks, as more of these come to market in 2025. This trend started in 2024 and the economic health of the site industry suggests it will continue next year.

Both trends will continue and, as networks grow and become more common, there will be a need to educate industry and policymakers on the benefits they offer and ensure networks can provide a reliable, consistent service. This shift will precipitate the formation of a trade association that can advocate for site organizations and put measures in place to guarantee consistency and quality for those engaging multisite organizations. 

1. Access to purpose-built technology will increase 

There was no escaping mention of Generative AI (GenAI) in 2024, which will likely be just as prominent in 2025. A Deloitte survey of 150 C-suite executives in pharmaceutical and medical device manufacturing found that 60% intend to increase GenAI investments across their operations next year. 

With the rise in networks — which have the scale and resources at their disposal — we’re also likely to see an increase in technology (digital tools and AI) developed specifically for sites by sites. This will inevitably lead to increased interoperability of technologies as sites gain access to purpose-built tools that address their day-to-day challenges. 

Ultimately, this will put sites in a stronger position to advocate for using their own tech, a trend with wide-reaching benefits. Using universal or interoperable tech platforms will prevent site staff from switching between multiple, independent systems, which adds unnecessary admin burdens and contributes to burnout, and increase their ease with the system they’re using, ensuring better, more consistent data for Sponsors and CROs. 

1. There will be a surge in obesity trials

Early studies have shown GLP-1 antagonists are well tolerated and effective in weight loss and lowering blood sugar. The success of this class of drugs has already contributed to a significant growth in obesity studies and an increased demand for patient populations with high BMIs. 

With more than half of the world’s adults expected to be classified as obese or overweight by 2035, GLP-1 antagonists hold substantial commercial potential. Over the next decade, research is likely to prioritize metabolic enhancement and the development of novel delivery mechanisms for these drugs.

1. Changing policy and regulatory shifts will drive uncertainty

The FDA issued all guidance related to the Federal Drug Omnibus Reform Act (FDORA) in June 2024. This includes guidance on the late-stage protocol submissions required under the Diversity Action Plan (DAP), a mandate intended to ensure that clinical trials better reflect real-world patient demographics.

Currently, DAP is set to take effect from June 2025. However, whether the new Administration will support or enforce it is unclear. The Trump team has yet to comment publicly on the mandate, and there is the possibility that they will delay or stall the project indefinitely. 

Uncertainty around the new Administration’s stance on vaccine development also has the potential to contribute to vaccine study delays and cancellations. It may force trials into territories outside of the US, increasing business for sites in the EU and South America.

Looking ahead 

While 2025 promises advancements, much of the focus will center on consolidating existing trends. The industry’s growing reliance on multisite networks and the development of purpose-built technologies should help to drive efficiencies, reduce costs, and enhance patient engagement, improving overall trial quality and delivery. 

However, there are challenges ahead, including the possibility of evolving diversity mandates and uncertain policy priorities. If we can successfully meet these as an industry, we can continue to advance the quality, inclusivity, and impact of our work.