number of expert sources shared with Global Forum their additional predictions on new topics for 2025. They are grouped by contributor or contributing organization.
AI will go from use case to main case to transform clinical trial operations before the end of 2025.
By the end of 2025, artificial intelligence (AI) will transform clinical operations, dramatically improving efficiency and productivity. Already, generative AI enables automation of labor-intensive tasks, but there is also promise in predictive analytics, which can leverage historical and real-time clinical operations data to forecast outcomes, optimize resource allocation, and streamline timelines. AI will also soon be used more to extract key information from protocol documents to populate downstream systems, reducing manual entry errors and increasing speed. This same data will also start to be used to auto-generate study calendars based on the schedule of assessments, streamlining trial planning.
Additional use cases that will become more common this year include using AI to analyze past trials and recommend improvements based on data patterns. Site selection will also benefit from AI by identifying optimal sites with the greatest likelihood for patient recruitment success, considering factors like demographics, past performance, and patient availability. As AI continues to evolve, 2026 will give way to transformative improvements in clinical trial efficiency, quality, and performance.
Connecting technology will prove key to overcoming 2025’s expected clinical workforce shortage.
The clinical trial workforce is in short supply. According to our recent survey of academic medical centers, nonacademic care centers, and professional site/site networks, over 40% of sites are experiencing a principal investigator (PI) shortage, and 65% report a shortage of research coordinators. Further, one-quarter of site respondents and 16% of sponsors/CROs pointed to staffing issues as an area needing improvement. The staffing challenge at sites continues to persist across the US. Nationwide, for every experienced clinical research coordinator seeking work, seven jobs are posted.
In 2025, sponsors will adopt site-centricity along with their focus on patients by finding ways to improve efficiency for sites. Otherwise, we jeopardize the execution of trials. Improving technology, which has been repeatedly cited by sites as adding to their burden, will be the first step. Sponsors and CROs as well as their technology partners will seek to connect sites’ systems with their systems. Connecting the site and sponsor technology ecosystem for a smooth flow of users, data, and documents will not only improve productivity, but also increase protocol compliance, a win/win for both sites and sponsors.
Next year, technology will help sustain the clinical research workforce which, in turn, will allow sites to do more trials and focus more time on patient care.
Increasing clinical trial complexity will give way to the development of industry standards.
A staggering 70% of sites say clinical trials have become more challenging to manage in the last five years due to increasing complexity. Trial complexity has far-reaching implications in terms of cost and timeline. One promising approach is the adoption of industrywide standards, which can open the door to greater connectivity and a digitized data flow. For example, use of a common protocol template can drive consistency and efficiency, reducing the time and effort needed for study design and technology setup. Standardization also simplifies integration between site and sponsor technology systems, enabling all users to operate in their system of choice, and data and documents to flow throughout the connected ecosystem. In 2025, clinical research stakeholders will have no choice but to come together to establish industrywide standards and apply them consistently across all phases of research.
Integration will replace isolation in site technology.
The clinical research industry has seen an explosion of technologies that have helped make trials more patient- and site-focused and accessible and, in many ways, more operationally efficient. However, the sharp increase in technology has also contributed to greater trial complexity. In Advarra’s 2024 Site-Sponsor/CRO Collaboration survey, only 29% of site respondents agreed that sponsor/CRO technology solutions deliver the promised value for integration and efficiency.
Part of the problem is that technologies address specific isolated pain points rather than the broader, systemic challenges that sites encounter, creating a disjointed technology landscape that increases rather than alleviates the workload at the site level. By the end of 2025, the site portal approach common today will be replaced by integrated systems that improve transparency and streamline workflows to accelerate study start up. Collaboration between sponsors, vendors, and sites will be essential, but the key will be streamlining technology in ways that reduce administrative load rather than complicate it.
Regulatory agencies will increase their focus in 2025 on regulations for vulnerable populations.
Regulatory and other oversight bodies in the US, particularly the US FDA and the Department of Health and Human Services (HHS), issued many new draft and finalized guidances in 2024 to drive harmonization in the clinical research industry. Over the years, these agencies have made significant strides in aligning their rules and guidance, as seen with the harmonized definition of an Institutional Review Board (IRB), informed consent, and the recent implementation of the single IRB (sIRB) model. This push for consistency aims to streamline regulatory processes and reduce administrative burdens for sponsors and researchers.
In 2025, harmonization will accelerate and focus more on refining guidelines and regulations for vulnerable populations, including children, pregnant women, and prisoners who require special protections. Aligning regulations across agencies will simplify the ethical review and approval process for studies involving these populations and provide consistency for more efficient trial oversight while ensuring the highest standards of protection for vulnerable participants. It will also foster a clearer, more unified regulatory framework, reducing confusion for sponsors and researchers, ultimately enhancing the inclusivity and efficiency of clinical research involving vulnerable groups.
Technology change-makers will deliver unified, interoperable study start-up solutions.
The fragmented way the clinical research industry addresses individual pain points with siloed solutions has contributed to study start-up delays. While these targeted technologies may offer immediate relief in specific areas, they do not integrate with other aspects of the start-up process.
The complexity of study start up demands a holistic strategy that prioritizes system integration and data connectivity. Technology providers must link key steps, such as site selection, regulatory submissions, and contract negotiations, and enable real-time data sharing to help improve transparency, reduce redundancies, and guide decision-making during study start up. The providers that shift from fixing individual pain points to building a unified, interoperable framework that brings together data and processes across the study start-up ecosystem will be true change-makers in 2025.
Alternative clinical trial primary endpoints will expedite FDA drug approvals.
Advances in the therapies available to patients with certain types of cancer have increased progression-free survival (PFS) and overall survival (OS) from weeks or months to years or decades. This testament to medical progress has created a situation where clinical trial duration has become an ever-increasing cost burden for drug developers. The time needed to demonstrate the efficacy of a new drug is so long that there is also concern that interim advances will have reduced the clinical relevance and impact of the “new” drug’s approval. Furthermore, if a patient’s disease progression can be mitigated by selection of a different therapeutic option that successfully prolongs life expectancy, PFS becomes a less useful endpoint for trial design.
All of this has led to a call for earlier endpoints for clinical trial evaluation. In April 2024, the US FDA convened its Oncology Drug Advisory Committee (ODAC) to consider the possibility of using measurable residual disease (MRD, a direct, quantitative evaluation of tumor burden) and some time point post-diagnosis as a primary endpoint for accelerated drug approval. The committee voted unanimously to recommend the use of MRD as a primary endpoint. While FDA has not yet formally commented on the ODAC’s recommendation, and any submission for a new drug approval will have to have its own trial design and data generation evaluated on its own merit, the vote of this ODAC meeting opens the door for a consideration of alternative relevant biomarkers to expedite drug development.
AI will redefine how clinical research is executed.
As we move into 2025, artificial intelligence (AI) is poised to redefine the landscape of clinical research, particularly trials that utilize decentralized elements. AI facilitates the collection and analysis of data at unprecedented speeds. This holds enormous promise for clinical research, including allowing researchers to monitor treatment effects continuously. It is also proven to reduce trial timelines and thereby accelerate the delivery of new therapies to patients. In 2025, the winners will focus on building robust AI systems that prioritize speed without compromising data integrity, security, and patient privacy. Leaning into AI in 2025 will accelerate a clinical research ecosystem that is faster and more equitable.
The life sciences industry will finally witness the realization of AI’s promise in clinical trials, moving beyond years of hype to tangible, industrywide transformation.
This is the year AI converges with SaaS tools to redefine the clinical trial process entirely, shifting from a service-heavy, project-based model to a scalable, technology-first paradigm. Key innovations, like fully automated and error-free protocol builds, will enable therapy sponsors to embrace hyperadaptive trial designs that evolve in real time. This is not just about efficiency; it’s about reimagining the critical path in ways never seen before. Trials that once took years to plan and execute will be built and optimized in weeks, driven by AI tools that offer unprecedented speed, precision, and scalability.
For the first time, AI-driven SaaS solutions will make clinical research truly scalable. Sponsors will gain access to self-service platforms capable of dynamically adjusting to evolving needs, empowering teams to take control of the process without waiting for manual intervention. The fruits of AI are no longer theoretical. By 2025, the technology will deliver on its long-held promises, giving sponsors the tools to build smarter, faster, more resilient trials. This paradigm shift will elevate the industry’s ambitions, breaking free from outdated constraints and enabling the rapid development of life-changing therapies on a global scale.
Trials will be simultaneously submitted for approval by regulators and for reimbursement by payers.
Regulators and payers both require evidence for approval and coverage determinations. Historically, that has led to two sets of evidence-generation activities, one satisfying regulators’ need for safety and efficacy evaluations of new medical products and the other satisfying payers’ need to understand how the new medical product compares to available treatments to determine costs. This would take about 12-24 months out of the time a treatment can reach patients who are waiting for it. Approved drugs are often rejected for reimbursement by payers (CMS, Insurance, HTA bodies) because of uncertainties related to clinical evidence comparisons to available treatments. Approval trials typically test out the drug in a narrower patient population.
With the increased use of decentralized elements and real-world data, trials can soon satisfy both regulators and payers. Technology enables us to collect data in real time during a participant’s normal day, allowing us to determine whether this treatment works in the intended population in the real world while collecting data on efficacy and safety. Simultaneously, trials with decentralized elements are showing that the trial populations are becoming more representative. Combining these two trials into one will shorten the time a patient would have to wait to buy that new medical product on the market by up to two years.
We finally connect workflows end to end to drive accelerated approvals.
Clinical trial sponsors are frustrated by the industry status quo, as the time, costs, and efforts of clinical studies continue to escalate. With the emergence of compounds with novel mechanisms of action, the need to monitor and measure new endpoints with higher specificity and in real time is critical. Industry needs to harness digital and offer end-to-end workflows and endpoint measurements for study data acquisition, including remote patient monitoring (such as for known toxicities associated with ADCs); this is going to be significant for 2025. A single platform with consumer-style experience that allows for rapid deployment from a best practices library to simplify capturing data that truly matters to patient outcomes and scientific evidence is key.
Investing not only in data acquisition, but also in automated data flow into dynamic decision-making tools throughout drug development (rather than at the end of each study) will support the basket/master protocols and cohort designs that facilitate learning and decision-making in accelerated approval pathways.
Ten 2025 Regulatory Predictions for Medical Devices and Their Use in Clinical Practice and in Clinical Trials of New Medical Products
The medical device industry has experienced rapid transformation, driven by technological advancements, changing patient needs, and evolving regulatory frameworks. As we look towards 2025, it’s crucial to anticipate the regulatory challenges and opportunities that lie ahead.
Realistic Predictions
AI-Driven Personalized Medical Devices
A significant surge in AI-driven personalized medical devices is anticipated, prompting the FDA to issue comprehensive guidance on AI algorithms that tailor device functionality to individual patient characteristics. This guidance will likely address algorithm transparency, continuous learning capabilities, and real-time adaptability. Manufacturers will need to demonstrate robust validation protocols for AI algorithms, including methods for handling data bias and ensuring algorithm stability across diverse patient populations, in regulatory submissions. These developments will necessitate more sophisticated adaptive clinical trial designs that can account for individual patient responses and the dynamic nature of AI-driven devices.
5G-Enabled Remote Monitoring Devices
With the widespread adoption of 5G networks, new FDA regulations are expected to address the use of high-bandwidth, low-latency remote monitoring devices in clinical trials, drugs and drug development, and patient care. These regulations will likely focus on data security, reliability standards, and interoperability of devices. Guidelines on encryption protocols, data transmission integrity, and real-time error detection mechanisms are anticipated. Clinical research will benefit from real-time, high-quality data collection in decentralized trials, enabling more frequent patient monitoring and rapid intervention when necessary.
Expanded Use of Real-World Evidence
FDA is expected to significantly expand its acceptance and guidelines for using real-world evidence (RWE) in regulatory decision-making for medical products and devices, particularly for post-market surveillance. This expansion will likely include more comprehensive frameworks for data collection, analysis, and interpretation of RWE. Regulatory affairs professionals will need to develop sophisticated strategies for gathering and presenting real-world data, potentially incorporating advanced analytics and AI-driven data-mining techniques. Clinical researchers will face the challenge of designing hybrid studies that effectively bridge the gap between controlled trials and real-world use.
Comprehensive Cybersecurity Threat Modeling
A critical shift is anticipated in the regulatory landscape concerning cybersecurity: FDA is expected to mandate comprehensive cybersecurity threat modeling during the design phase of connected medical devices, reflecting the urgent need for enhanced security measures in an increasingly interconnected healthcare environment. This requirement will involve a thorough assessment of potential vulnerabilities, risk factors, and mitigation strategies tailored to each device’s specific functionalities and use cases, during clinical trials and post-market (real-world) use. Manufacturers will be tasked with demonstrating robust security protocols, including end-to-end encryption, secure boot processes, and proactive patch management, to protect against emerging threats.
Moderately Realistic Predictions
Blockchain for Medical Device Traceability
FDA is set to propose regulations incorporating blockchain technology for enhanced medical device traceability throughout the supply chain, aiming to improve recall efficiency and patient safety. This innovative approach will likely require manufacturers to implement distributed ledger systems that provide immutable records of device production, distribution, and usage. While promising, full implementation may face challenges such as standardization across diverse supply chains and integration with existing systems.
Augmented Reality in Surgical Devices
Integration of augmented reality (AR) in surgical devices is poised to revolutionize medical procedures, prompting the development of new guidelines focused on safety standards and efficacy measures for these advanced visualization tools. Regulatory bodies will likely address the unique risks associated with AR in surgical settings, such as potential distraction, depth-perception issues, and system latency. These guidelines may require manufacturers to demonstrate robust fail-safe mechanisms and conduct extensive usability testing in simulated surgical environments.
Adaptive Clinical Trial Designs for Devices
FDA is poised to issue new guidance on adaptive clinical trial designs tailored specifically for medical devices, ushering in an era of more flexible and efficient product development. This paradigm shift will challenge regulatory affairs professionals to develop dynamic submission strategies that can accommodate real-time adjustments based on interim data analysis. Clinical researchers will need to master novel statistical methods, such as Bayesian approaches and seamless phase designs, to effectively implement these adaptive trials.
Less Certain but Possible
Quantum Computing in Medical Diagnostics
Regulatory discussions on quantum computing in medical diagnostic devices are set to begin, challenging regulatory affairs professionals to develop novel frameworks for validating quantum-based algorithms in complex diagnostic applications. While widespread implementation may be limited in the near term, this emerging technology promises to revolutionize the analysis of intricate biological systems and drug interactions, potentially leading to breakthroughs in personalized medicine and drug discovery.
Nanotechnology-Based Medical Devices
FDA is set to begin addressing the unique challenges of regulating nanotechnology-based medical devices, particularly those designed for targeted drug delivery and microscopic diagnostics, necessitating the development of novel testing and validation protocols. As these devices become more prevalent, regulatory affairs professionals will need to create comprehensive frameworks that ensure safety and efficacy, while clinical researchers must design innovative trials that effectively evaluate the interactions and behaviors of nanoparticles within biological systems.
Eco-Friendly Medical Devices
FDA is expected to introduce regulations promoting the development of environmentally sustainable medical devices, encompassing guidelines on recyclable materials, energy-efficient designs, and lifecycle assessments. This shift will require regulatory affairs professionals to incorporate sustainability metrics into device submissions, while clinical researchers may need to consider environmental impact as a new factor in device evaluation. These regulations could potentially include requirements for manufacturers to demonstrate reduced carbon footprints, implement take-back programs for device disposal, and utilize eco-friendly packaging materials, marking a significant step towards aligning medical device innovation with global sustainability goals.