As the clinical research landscape advances, the 2025 WCG Trends and Insights Report highlights the most critical trends and innovations transforming when and how therapies are delivered to patients. Drawing from WCG’s deep expertise, this year’s report focuses on five pivotal areas, offering actionable insights to navigate the future of clinical trials.
Diversity in Clinical Trials remains a cornerstone of equitable research. Increasing representation in trials is essential for delivering therapies that benefit all populations. This year’s report explores strategies for breaking down barriers, from community outreach to novel recruitment models.
The rise of Artificial Intelligence and Machine Learning is redefining operational efficiency. By optimizing trial design, participant recruitment, and site performance, these technologies are helping to accelerate timelines while enhancing trial precision.
Regulatory Innovation and the role of single IRB models reflects a significant shift toward streamlining review processes. Single IRBs are improving consistency, reducing redundancy, and shortening study start-up times, especially in multi-site trials, paving the way for greater collaboration and efficiency in trial governance.
The focus on Site Preparedness for Future Clinical Trials emphasizes the elements that drive, and enable, success. Infrastructure and training, and fostering trust, collaboration, and team cohesion are all emerging as differentiators in site performance and participant engagement.
Finally, Precision Oncology and Biomarker-Driven Trials are ushering in a new era of tailored therapies. With biomarker-based approaches at the forefront, oncology research is delivering more targeted, effective treatments for patients, setting a new gold standard in personalized medicine.
These trends underline the innovation, inclusivity, and efficiency shaping clinical research in 2025. This year’s report equips stakeholders across the ecosystem with the knowledge to adapt, excel, and contribute to advancing clinical trials and improving patient health.
In recent years, diversity, equity, and inclusion (DEI) have become essential focus areas in clinical trials, with a primary goal of increasing participant diversity. However, the push for inclusivity extends far beyond enrollment numbers. According to WCG data, participant diversity has improved significantly, with minority representation in trials increasing by 25% from 2018 to 2022. Gender representation has also seen a positive shift, with women now constituting 52% of trial participants, a notable increase from 45% in 2018. Additionally, our data indicates that the geographical reach of our clinical sites has expanded, with principal investigator (PI) locations now covering more diverse regions, enabling greater participation from varied demographic groups.
To address the evolving DEI practices, clinical trials are now designed to account for genetic, lifestyle, and environmental factors unique to different demographic groups. This approach aims to build a foundation for treatment decisions that better serve all patients, reducing healthcare disparities and fostering broader public trust. Data from WCG shows that trials incorporating these inclusive designs report a 30% higher retention rate among diverse populations.
As we progress, focusing on equitable data representation is critical to producing results that truly represent the global patient population, helping sponsors, regulators, and clinicians make informed, inclusive healthcare decisions.
Discover WCG’s expert perspectives on advancing DEI in data for the next generation of clinical trials:
Diversity in Clinical Research: Every Participant Counts
Blog Posts
The Importance of Diversity in Clinical Trials and the Impact of FDA Guidance
Blog Posts
Challenges and Innovations in Rare Disease in 2025
Blog Posts
Diverse Recruitment Strategies and the Future of Inclusive Clinical Trials
Blog Posts
The Intersection of Diversity and Technology in Clinical Trials
Blog Posts
Diversity in Clinical Trials: A Scientific Imperative for 2025
Blog Posts
The ability of clinical trial sites to operate efficiently and adapt quickly to sponsor needs is crucial for successful trial execution. According to WCG’s 2024 Clinical Research Site Challenges Report, a common hurdle is the need for improved communication and streamlined collaboration between sponsors and sites. Addressing these challenges requires building a framework that supports better site readiness, including enhanced training, real-time data access, and clear communication pathways.
The report highlights that 78% of sites experience delays due to poor communication, and 65% of sites identify the lack of real-time data access as a significant barrier. Additionally, 72% of sponsors believe that enhanced training would substantially improve site performance. When sponsors work closely with sites to align on protocols, timelines, and resources, the likelihood of avoiding delays and mitigating site-level challenges increases significantly. As we look to future trials, empowering sites with the necessary tools and support is key to ensuring streamlined operations, timely participant recruitment, and high-quality data collection, ultimately setting a strong foundation for trial success.
Learn more from WCG’s experts on advancing site readiness for future clinical trials:
Elevating Site Preparedness: Trends and Strategies for 2025
Blog Posts
According to recent studies from the Tufts Center for the Study of Drug Development, the integration of artificial intelligence and machine learning in clinical trials can reduce study timelines by up to 30% and cut costs by as much as 20%. Predictive models powered by AI can analyze vast datasets, identifying potential delays and risks before they arise. This proactive approach allows sponsors and CROs to allocate resources effectively, cut down on trial duration, and reduce costs.
In addition to operational efficiency, AI-driven analytics are enhancing the precision of patient recruitment and retention, and endpoint tracking, ensuring that trials stay on course to meet their objectives. By leveraging these technologies, clinical research is becoming more adaptive, agile, and cost-effective, opening the door to an era of more dynamic and efficient clinical trials.
Read on to explore how WCG’s thought leaders are driving AI innovation in clinical trial operations:
Harnessing AI and Machine Learning in Clinical Development
Blog Posts
The Role of AI in Predictive Biomarker Patient Matching
Blog Posts
Generative AI: The Path to Unlocking Value
Blog Posts
The global market for precision oncology is on track to reach $98 billion by this year, highlighting the growing investment and interest in this field. This surge in personalized medicine is underscored by the rise of basket and umbrella trials, which enable the concurrent testing of multiple targeted therapies across various cancer types or genetic mutations.
Precision oncology is swiftly revolutionizing cancer treatment by emphasizing biomarker-driven trials that target specific genetic and molecular profiles. Biomarkers, which are measurable indicators of biological processes, pathogenic processes, or responses to an exposure or intervention, are not limited to oncology but play a pivotal role across a range of medical fields. These markers help guide researchers in identifying which patients are most likely to benefit from specific therapies, thereby personalizing treatment approaches.
As our comprehension of cancer genomics expands, clinical trials are increasingly tailored to individual patients, often based on the unique biology of their tumors. Biomarkers play a crucial role, guiding researchers in identifying which patients are most likely to benefit from specific therapies.
This targeted methodology not only enhances the effectiveness of treatments but also reduces unnecessary exposure to ineffective therapies, thereby improving patient safety. The shift towards biomarker-driven trials in oncology and other therapeutic areas like CNS signifies a move toward a more personalized, data-driven approach to treatment, which holds great promise for improving patient outcomes.
Discover WCG’s expert perspectives on the future of precision oncology and the design of biomarker-driven trials:
Advancing Precision Medicine in Oncology: From One-Size-Fits-All to Biomarker-Driven Treatments
Blog Posts
Advancing Precision Medicine: Harnessing Molecular Biomarkers for Oncology Clinical Trials
Blog Posts
The Next Wave of Innovation: Silence Speaks Volumes in Clinical Research
Blog Posts
In an era where clinical research is more complex than ever, regulatory innovation is essential to streamline processes and safeguard participants’ rights while accelerating the development of life-saving treatments. As the research landscape continues to evolve, regulatory bodies like the U.S. Food and Drug Administration (FDA) are taking significant steps to modernize and harmonize regulations, making it easier for sponsors, institutions, and investigators to conduct trials that meet high standards of rigor and efficiency.
One major focus of regulatory modernization is the push for single IRB (sIRB) review in cooperative research. This approach, already mandated by the Common Rule for federally funded studies, requires only one Institutional Review Board to oversee research involving multiple institutions, reducing duplicative reviews and expediting study initiation.
The FDA’s proposed rule to mandate single IRB review in FDA-regulated research marks a critical alignment with the Common Rule, signaling a step toward consistency across regulatory frameworks. While the proposed rule would streamline oversight and reduce administrative burdens, the FDA has outlined specific exceptions for cases where local expertise is crucial, or where product-specific regulatory pathways apply.
Though many sponsors have already adopted single IRB practices voluntarily, FDA’s formalization of this requirement will necessitate changes for some institutions and investigators. Adjustments to standard operating procedures (SOPs) and resource allocation will be necessary, particularly for those who have not yet transitioned to this model. With the final rule anticipated this year, stakeholders have an opportunity to align processes in anticipation of this shift.
The following provide deeper insights on single IRB (sIRB) review, including an analysis of the FDA’s proposed rule and an overview of the rulemaking process. Together, these perspectives illustrate how regulatory innovation is reshaping the clinical trial landscape and advancing research efficiency for all stakeholders.
FDA’s Proposed Rule for Single IRB Review in Cooperative Research
Blog Posts
FDA’s Single IRB Requirement, Expected but Not Guaranteed in 2025
Blog PostsLearn more about our Trends and Insights Report for 2025
Fill out this form to contact WCG with any questions and comments, to learn more about our authors and insights into the 2025 Trends and Insights Report.