The Future of Clinical Trials: Four Key Trends to Watch in 2025

Rust Felix
Co-founder and CEO
Slope

The clinical trial landscape is on the brink of transformation in 2025, driven by groundbreaking shifts in regulation, technology, and collaboration. The convergence of new industry guidelines, increasing operational complexity, and the pressing need for innovation is reshaping how the industry approaches biospecimen management, compliance, and tech adoption.

Among the most significant changes is the European Union’s leadership in implementing the ICH E6(R3) guidelines. These updates emphasize data integrity and traceability, setting new benchmarks for quality that reflect the increasing complexity of protocols while signaling a growing need for industry collaboration. Going into the new year, we now find ourselves with an incredibly unique opportunity to reimagine how trials are executed, creating pathways for greater efficiency and precision that have the potential to bring even more new therapies to market.

To navigate the evolving landscape, I believe clinical trial professionals should focus on four critical trends: increased compliance demands, a heightened focus on data integrity and traceability, renewed focus on industry collaboration, and a growing need for integrated, site-friendly technology solutions. By understanding and preparing for these developments, stakeholders can better prepare themselves to navigate the inevitable challenges ahead.

There will be increased compliance demands driven by ICH E6(R3) adoption

With the EU advancing ICH E6(R3) guidelines, I predict that sample metadata standards will tighten globally, impacting all aspects of the biospecimen lifecycle. The guidelines’ explicit focus on data governance introduces stringent requirements for sample metadata capture, audit trails, and documentation. This means that sponsors will be expected to have more rigor in their processes when it comes to how they manage the increasing volume of data and stakeholders that support clinical research. Sponsors will need to prioritize compliance and visibility across the entire biospecimen lifecycle, raising industry-wide expectations for data integrity.

The emphasis on “quality by design” within E6(R3) underscores the need for proactive risk mitigation and precision in managing biospecimens and their associated data. The guidelines call for “clinical trial processes and risk mitigation strategies” that are “proportionate to the importance of the data being collected and the risks to trial participant safety and data reliability.” It goes without saying that the processes that govern the management of patient samples and their associated data demand a level of rigor that reflects their significance to patient safety and study outcomes. By embedding quality assurance measures for biospecimens across the entire lifecycle, sponsors can elevate the reliability of trial results while reducing regulatory risk.

Elevated focus on biospecimen data integrity and traceability will lead to more audits

Regulatory scrutiny of biospecimen data is intensifying, with greater attention on sample logistics, chain of custody, and lifecycle management. Sponsors will be required to provide meticulous documentation covering every stage of a sample’s journey—from collection, chain of custody, and analysis, to retention and destruction¹). This heightened oversight will undoubtedly lead to more frequent audits, creating a demand for comprehensive solutions that ensure traceability and compliance across every site and lab that supports each trial.

Academic Medical Centers, which have faced growing challenges in managing biospecimen source data, must also adopt built-for-purpose solutions to ensure their processes lend themselves to accurate and efficient sample metadata capture. By leveraging tools that support seamless sharing of more reliable data with labs, CROs, and sponsors, research sites can minimize errors and avoid costly audit failures.

There will be a rise of collaborative standards among industry stakeholders

In 2025, the industry is poised to take significant strides toward standardization in biospecimen management. Stakeholders across the industry are recognizing that fragmented processes hinder efficiency and compliance. The call for harmonized best practices is growing louder, and collaborative efforts will be critical to creating meaningful change. I expect to see more unified efforts to streamline sampling compliance, harmonize sample metadata exchange, and reduce the operational burden on all study stakeholders—from research sites to labs and sponsors.

When it comes to industry collaboration, clinical trial professionals should consider opportunities to engage with their peers through consortiums and working groups that influence the development of collaborative guidelines and regulations. The Biospecimen Management Consortium (BMC) and the Patient Centric Sampling Interest Group (PCSIG) are just a few examples of organizations that are bringing together diverse perspectives from across clinical research to educate the industry, develop best practices that impact sample management, and more. Sponsors should also consider ways to foster collaboration in the form of interoperable, vendor-agnostic technology that streamlines biospecimen management across their sites and labs.

Lab technology solutions will increase site burden

As labs continue to develop proprietary e-requisition solutions, research sites are increasingly burdened with managing a patchwork of tools and portals that lack interoperability. These systems may solve specific lab challenges, but they often introduce inefficiencies for sites—leading to issues with adoption, delays, and compliance risks. What’s more, these solutions can’t integrate with electronic data capture (EDC). Without vendor-agnostic solutions that work across all labs and EDC systems supporting a trial, sponsors will face challenges in meeting increasing compliance standards without overloading research sites with lab-developed point solutions.

Sponsors can combat this by opting for integrated solutions that centralize sample metadata management across all sites and labs that support a clinical trial. Digitized sample management workflows can be used to capture data from research sites during sample collection or within hours of collection, ensuring that this data is automatically shared with EDC and all downstream labs through integrations. Giving sites holistic tools and the flexibility to manage patient samples with greater efficiency and compliance fosters stronger collaboration and better study outcomes.

Looking ahead

The future of clinical trials is one of both challenge and opportunity. Sponsors who embrace the shifts in compliance, data integrity, collaboration, and technology adoption will be well-positioned to lead the way in transforming clinical research. By fostering innovation and collaboration, the industry has an unprecedented opportunity to redefine compliance and operational efficiency, paving the way for life-changing therapies to reach patients faster. Now is the time to rethink how we approach biospecimen management and data integrity.

Sources

1. Goo Clinical Practice. ICH. May 19, 2023. https://database.ich.org/sites/default/files/ICH_E6%28R3%29_DraftGuideline_2023_0519.pdf