The global clinical trials landscape continues to evolve apace. The use of new technology is gathering momentum, enhancing patient engagement and streamlining data collection in decentralized and hybrid trials.
In tandem, trials are becoming increasingly complex and expensive as they target smaller, specific patient populations, rely on larger and more diverse datasets, and navigate stricter global regulations. Smarter, more efficient trial designs will be critical to success.
As we look to the year ahead, here are six key trends poised to dominate in 2025.
1. Growth and impact of real-world evidence
Real-world evidence (RWE) encompasses data collected from various sources, including electronic health records, patient reported outcomes, claims databases, patient registries, and wearable devices, and it offers a wealth of insights into patient outcomes and treatment effectiveness beyond traditional clinical trials, that provide insights into treatment safety and efficacy.
RWE allows broader patient representation, as it includes data from a diverse range of patient demographics in contrast to the strict criteria and limited populations in a clinical trial. It also offers insights into the long-term safety and effectiveness of interventions, complementing the knowledge gained from trials, and provides valuable evidence on comparative effectiveness of different treatment options, enabling treatments to be tailored to individual needs.
RWE is increasingly being used as a basis for clinical trial design, identifying knowledge gaps and guiding the development of more efficient and patient-centered research protocols.
In 2025, it’s expected that RWE will:
- Streamline clinical trials and accelerate the time to market for new therapies
- Inform treatment decisions and monitor long-term outcomes
- Optimize resource allocation and reduce healthcare costs
2. Decentralized clinical trials and the evolution of patient-centric models
The move to decentralized clinical trials (DCTs) continues to be a major focus due to their potential to make trials more accessible, especially in rare disease studies and geographically dispersed populations.
“There is already evidence showing that DCTs can reduce recruitment timelines by up to 40% and significantly improve retention rates”, states Parul Sharma, Viedoc’s Chief Commercial Officer. Parul goes on to predict “In 2025, investments in infrastructure to support remote monitoring, particularly in emerging markets, will take center stage as sponsors strive for broader inclusivity and lower costs.”
With the growth of DCTs, ensuring robust patient safety and continuous monitoring in a decentralized setting is of paramount importance. Traditionally, trials have treated patients as sources of data only, but trial designs must consider what is most convenient for patients and provide them with benefits.
Majd Mirza, Chief Innovation Officer at Viedoc, summarizes, “ePRO and patient platforms/portals must focus on patient centricity, ensuring that patients have access to their data at all times. Patients should be able to review their progress in a trial, and benefit from participating in a trial beyond just receiving the medication. And to further ease participation in trials, there will be an increased emphasis on passive data collection using wearables and other devices, and more importantly, data collection from EHR.”
3. AI and innovations in biomarker technologies
One of the most transformative trends in 2025 will be the accelerated adoption of AI in clinical trials. Global AI use is growing exponentially, featuring in almost every aspect of daily life, and clinical trials are no exception. From simplifying medical coding to spotting patterns in patient-reported data, and reducing operational inefficiencies, AI holds much promise to deliver real, measurable value. AI is already proving to be a game-changer, enabling faster trial timelines, improved accuracy, and significant cost savings. Integration of AI-based approaches will continue to improve drug discovery, data analysis, and reshape clinical trials by reducing trial timelines and improving workflows.
We can expect to see growing investment in AI-powered biomarkers for patient monitoring and analysis, such as wearables. Digital biomarkers from wearables offer objective and continuous measurements of physiological and behavioral parameters throughout the day with minimal input needed from the patient.
By incorporating these advanced biomarkers into clinical trials, researchers can enhance patient stratification, improve treatment monitoring, and speed up the development of targeted therapies. Sponsors and contract research organizations (CROs) can also integrate them to gain insights into specific disease mechanisms and enable personalized treatment approaches.
While AI holds immense potential, it is important to recognize that it is not inherently a part of the clinical trial process—it is a tool, not the operator. Ensuring robust validation and regulatory alignment will be critical as AI continues to shape the future of clinical trials. Lina Gaggi, Product Manager at Viedoc, highlights both the promise and the pitfalls of AI in clinical trials:
“AI isn’t just speeding up clinical trials. It’s changing the game. Adaptive trial designs are reacting in real time to patient data. AI-driven synthetic control arms are reducing the need for placebo groups. Predictive analytics are identifying the right patients faster than ever. But here’s the uncomfortable truth: AI is not a magic fix. If we don’t validate and integrate it properly, it can reinforce biases, generate misleading correlations, and even slow trials down instead of speeding them up. The real breakthrough won’t come from AI itself. It will come from how we use it intelligently, ethically, and with full accountability. Otherwise, AI could end up being just another overhyped tool that fails to deliver on its promise.”
Alan Yeomans, Regulatory Affairs Manager at Viedoc, reinforces this caution, emphasizing the need for careful implementation: "AI has been getting a lot of attention lately, but it does not run clinical trials. It can be a valuable asset in solving technical challenges, but what truly matters is how AI systems in clinical research are implemented and validated. If not done properly, they could lead to inspection findings.”
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4. Data visualization and transparency
The integration of advanced data visualization techniques, coupled with new standards for data transparency, will significantly impact clinical trials in 2025, enabling faster, more informed decision-making, and enhancing the overall quality and integrity of clinical research.
Among the most significant regulatory changes to come in 2025 is the new 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.
ICH E6(R3) adoption will lead to increased compliance demands, as the focus on data governance introduces stringent requirements for sample metadata capture, audit trails, and documentation. Sponsors will need to prioritize compliance and visibility, and raise industry-wide expectations for data integrity, elevating the reliability of trial results while reducing regulatory risk.
Alan Yeomans clarifies “The new release of ICH E6 GCP (R3) emphasizes the importance of sponsor oversight and the adoption of risk-based, proportionate approaches. This requires critical thinking and the adoption of the principle of Quality by Design (QbD). Viedoc is at the leading edge in terms of transparency in everything we do, enabling our customers to prove compliance in the adoption of Viedoc in their clinical trials.”
The ability to generate transparent and interpretable reports that provide a comprehensive view of study results is critical, especially with increasing data complexity and evolving regulatory requirements. This transparency not only meets regulatory expectations but also fosters a culture of openness and accountability within the research community.
In 2025, the key trends shaping data visualization and transparency are likely to include:
- AI-powered data analysis to identify patterns and insights within large datasets
- Advanced interactive dashboards to visualize trends in real-time
- Implementing blockchain technology to enhance data integrity
- Standardized data reporting to ensure clarity and ease of interpretation
- Patient-centric visualizations promoting informed consent and engagement
5. Health equity and global inclusivity
In 2025, the industry will further intensify its focus on health equity and improved representation from remote and underrepresented communities, recognizing the importance of inclusivity for generalizability.
As detailed above, DCTs are already enabling diverse clinical trials with participation from all populations without geographic and logistic barriers. By leveraging AI to precisely identify and recruit participants from historically underserved populations across the globe, DCTs are poised to make clinical trials accessible to a truly representative cross-section of society, and ensure real-world populations are reflected.
Algorithms allow researchers to actively monitor enrollment data in real time so they can spot any imbalances early on and take corrective action. This avoids skewed outcomes, such as a heightened risk of adverse reactions in diverse ethnic groups and addresses health disparities.
6. Increased focus on data privacy and security
The NIS2 Directive and the Cyber Resilience Act (CRA) are two important pieces of EU legislation that have recently come into effect to enhance the cybersecurity of products and services in the digital single market.
Both regulations aim to achieve a high common level of cybersecurity across the EU by imposing security requirements on various entities and products with digital elements.
Although formally EU-based, together they are expected to have global and cross industry impact when it comes to cybersecurity and protection of data.
Predrag Gaic, Viedoc's CISO explains “the new regulations raise the focus on resilience, cybersecurity, incident management, and oversight measures for entities that provide services essential for the maintenance of critical social or economic activities, and will inevitably impact clinical trials.”
Discover how Viedoc can help streamline and advance your trials in 2025 by exploring why our EDC is consistently voted number one on G2.
