By Clinical Research Team 

January 7, 2025 | 2024 was full of innovative ideas and achievements. We spoke with industry experts and leaders about what to expect in the new year. Artificial intelligence (AI) provided clinical research and trials with increased efficiency, and it looks like this will continue into 2025. “The clinical trials landscape in 2025 will be shaped by significant advancements aimed at making research faster, more efficient, and accessible,” says Zizi Uzezi Imatorbhebhe of Bios Health Group. “Artificial intelligence will play a major role, optimizing trial designs and patient recruitment to cut costs and timelines significantly. Patient-centric approaches leveraging real-world evidence will ensure trials are more representative, capturing diverse, everyday data.” 

Underrepresented groups will be a trial inclusion priority. “Underrepresented trial populations will get more choice,” predicts Drew Garty of Veeva. “Patient enrollment and retention continue to challenge sites and sponsors, with trial complexity and patient fatigue contributing to high dropout rates. In 2025, sponsors that give patients more options for onboarding and trial visits will improve their experience and expand the participant pool to previously underserved populations.” 

There are also concerns about the Inflation Reduction Act and its effect on clinical trials, trial designs, and recruitment. “We will begin to feel the unintended consequences of the Inflation Reduction Act (IRA) in the coming year, and it will significantly change the landscape of clinical trials and drug development as we know it,” says Ariel Katz of H1. “As pharmaceutical companies shift their focus toward fewer, high-value therapeutic areas in light of the IRA’s drug price negotiations, the overall number of clinical trials will go down.” 

Here are the full predictions and trends, including more information on patient recruitment and retention, patient perspectives in clinical trials, AI/ML’s impact on drug development, and more. -- the Editors 

Elisa Cascade, Chief Product Officer, Advarra 

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 industry-wide 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 set-up. 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. 

Julie Ozier, Senior Vice President of IRB/IBC Regulatory Services, Advarra 

Regulatory agencies will increase their focus in 2025 on regulations for vulnerable populations: Regulatory bodies, particularly the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA), issued many new drafts 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. 

Vincent Keunen, Founder & CEO, Andaman7 

In 2025 and beyond, I expect to see AI capabilities aiding clinical trial patient recruitment and data processing: The development of new technologies will allow us to extract relevant health information from its current unstructured data formats and codify it into largely adopted health standards, making processing data for clinical research easier and more efficient than ever before. This can also facilitate patient recruitment by identifying candidates based on inclusion and exclusion criteria. And fortunately, AI will also help patients better understand their medical information and improve their literacy. 

Niven R. Narain, Ph.D., President and CEO, BPGBio 

As clinical trials grow increasingly complex, AI is poised to become an indispensable tool in advancing drug development by 2025 and beyond: Its ability to analyze vast amounts of biological and patient data enables researchers to design more efficient trials, select the right participants, and predict trial outcomes with greater accuracy. This transformative potential extends far beyond drug target discovery to optimizing every phase of clinical research. By leveraging AI to uncover insights into the biological mechanisms of therapies, researchers can tailor trials to specific patient populations, improving safety and efficacy outcomes. Additionally, AI tools can identify and address adverse events in real-time, allowing trial protocols to adapt dynamically. These capabilities not only enhance the success rates of trials but also accelerate timelines and reduce costs, ultimately benefiting patients worldwide. As we look ahead, AI will serve as the cornerstone of a new era in clinical innovation. 

Zizi Uzezi Imatorbhebhe, CEO, Bios Health Group 

The clinical trials landscape in 2025 will be shaped by significant advancements aimed at making research faster, more efficient, and accessible: Artificial intelligence will play a major role, optimizing trial designs and patient recruitment to cut costs and timelines significantly. Patient-centric approaches leveraging real-world evidence will ensure trials are more representative, capturing diverse, everyday data. Decentralized trials and remote monitoring, powered by wearable devices and digital platforms, will expand access and convenience for participants. Blockchain technology will revolutionize data security, ensuring transparency and integrity in trial processes. Together, these innovations will accelerate the path to groundbreaking treatments and make clinical trials more adaptive and inclusive than ever before. 

Patrick Hughes, Chief Commercial Officer & Co-Founder, CluePoints 

In 2025, we will see new political, regulatory and economic policies shift transformative change from a "nice to have" to a must have: As an example, reducing travel time to sites will reduce time and cost but also accelerate corporate sustainability commitments. The concept of “moonshot” will be re-categorized, and new realities will dictate the accelerated adoption of data driven, risk-based approaches. This will include things such as identifying fraudulent data patterns, tracking site performance and patient adherence, through to the use of data to perform scientific and medical checks across all patients. Ultimately, this new era of automation (intelligent AI) will take a leading position in clinical research, promoting the successful proliferation of time, cost and effort saving initiatives across R&D. 

Christian Olsen, Associate VP, Dotmatics 
Lab in a loop: For AI to make a meaningful impact in life sciences, the drug discovery process must evolve into a Lab-in-a-Loop model. In this model, R&D and clinical data from various applications, databases, and lab equipment are ingested, centralized, and used to create predictive models for guiding the next set of experiments. While traditional workflows are often viewed as linear, this approach requires flexibility to integrate new insights as they emerge from ongoing experiments. 

Ariel Katz, CEO and Co-Founder, H1 

Changes in Clinical Trials & Drug Development Due to the Inflation Reduction Act: We will begin to feel the unintended consequences of the Inflation Reduction Act (IRA) in the coming year, and it will significantly change the landscape of clinical trials and drug development as we know it. As pharmaceutical companies shift their focus toward fewer, high-value therapeutic areas in light of the IRA’s drug price negotiations, the overall number of clinical trials will go down. Additionally, we’ll see a move to multi-indication trials to maximize profitability. While this approach aims to improve ROI before potential price controls kick in, it complicates trial design and recruitment, increasing the time it takes to get treatments to market. Furthermore, as pharma looks to offset future price controls, the prices of new drugs will likely spike. This makes it more difficult for patients to afford treatments and contributes to health inequity. The downstream impacts of the IRA will lead to fewer new drugs entering the market, limiting treatment options for patients. 

Raja Shankar, Vice President, Machine Learning, Research and Development Solutions, IQVIA 

Generative AI and other AI-driven tools will continue to create notable shifts in how clinical trial sponsors and CROs approach decision making in clinical development: The most impactful benefit of Gen AI is how experts can use it to call on other forms of AI and traditional analytics as part of a multi-agent framework to dive deeper into insights that can guide sponsors’ decisions around how to optimize the value of their asset(s), clinical program development plans, and individual study strategy and execution. As the collaboration between these tech tools expands and gets fine-tuned, the potential for sponsors to secure better, critical insights to answer complex questions from discovery through commercialization will broaden. In parallel, CROs and others experienced in clinical uses of AI can anticipate an open dialogue with regulators on how to collectively ensure AI models are reliable and free of risks, further shaping industry guidance for safe and effective drug development. 

Michael Grosberg, VP, Model N 

While scrutiny of Pharmacy Benefit Managers (PBMs) has occurred on Capitol Hill and, to some degree, entered the public consciousness, 2025 will be a year of growing momentum rather than legislative action: Consumers are just now beginning to understand what PBMs are and the impact they have on drug prices. I expect to see more alignment between pharmaceutical manufacturers and independent pharmacies—many of whom are struggling—united by their concerns over PBM practices. This “enemy of my enemy is my friend” dynamic will lead to more combined lobbying efforts against PBMs. Heightened awareness and scrutiny will lay the groundwork for regulatory changes in the coming years, marking a significant shift from the constant blame aimed at “Big Pharma” for high drug costs. 

Sebastien Coppe, CEO, One2Treat 

The most impactful innovations in clinical trials will be those that prioritize the voices of patients: New regulatory guidance will accelerate the integration of the patient perspectives into clinical trial design. Tools developed to engage patients and incorporate their input before beginning to design Phase III trials will become a key differentiator, leading to more convincing trial designs, successful approvals, and faster time to market. By engaging patients early, invaluable insights into their needs, preferences, and lived experiences are gained, which in turn help define more relevant endpoints and ultimately improve the perceived value of the treatment. This approach will become the gold standard, driving a more patient-focused, effective drug development process. 

Graham Clark, CEO, Phastar 

An evolving drug development and clinical trials landscape requires new skills to manage detailed data and work with rapidly evolving technology: However, the talent to fill specialized roles is in short supply. In 2025, we will continue to face a critical shortage of skilled professionals. This shortage is likely to be felt most strongly in specialized roles like artificial intelligence (AI) experts, where recruitment competition from other industries is high, as well as data scientists and bioinformaticians. Big data, AI, and emerging digital health technologies present new opportunities to personalize treatments and improve trial oversight, but we need to be willing to adapt. Statisticians and SAS programmers will need to adjust to new ways of working, integrating AI, automation, and advanced tools for data management, analysis, and sharing into their processes. If we fail to evolve our skillsets alongside technology, we run the risk of missing out on key opportunities. 

Gen Li, Founder and President, Phesi 

The pharma R&D model has remained static for decades and is in need of rejuvenation: Costs keep going up, but productivity isn’t getting any better. This is in a dramatic contrast to our ability to bring innovative and exciting medical products to patients. This status quo has an impact on both big pharma, biotechs, and start-ups, with the need to demonstrate ROI becoming ever more critical. Big pharma continues to spend more money on R&D and many small firms lack the funds to continue investing when the first milestones have been met. 2025 is the perfect time to move away from this “traditional” model. The big focus over the next 12 months throughout the clinical development industry will be improving ROI by driving down operational costs, reducing trial cycle times, and making trials more precise. For many companies, this means embracing predictive analytics, big data and AI to make trials more precise and efficient, reducing development timelines and costs and significantly lowering burden on patients and investigators. 

Dan Goldstaub, Scientific Co-founder, PhaseV 

AI will drive a new era for drug development in 2025, amid growing industry acceptance and regulatory support: Continuing the considerable advances made in 2024, AI and machine learning will play an increasingly integral role in clinical trial design and analysis, continuing to evolve from predominantly preclinical use cases to become central to clinical development. We will see greater use of AI and machine learning in trial design and pipeline strategy, with the technology leveraged more to power complex and adaptive trials to increase efficiency and reduce trial costs while improving success rates. We are already seeing the industry shake off its inherent conservatism and embrace the technology, understanding its potential impact. This is tied to the positive shift among regulatory bodies. The FDA and EMA, acknowledging how advanced trial design improves efficiency and benefits patients, have been proactive in supporting advanced and complex trials, as well as the use of ML/AI-based tools in drug development. In 2025, we expect the industry to promote the wider and more scalable adoption of AI and ML, to reap the full rewards of these technologies. 

Martin Holm-Petersen, Chief Technology & Innovation Officer, Qinecsa 

In pharmacovigilance (PV) we are already seeing how new technologies are delivering a digital-first experience, helping us get data right first time and improving patient centricity: Unified adverse event platforms are streamlining how data is collected and centralizing processes. In 2025, we expect to see these technological advancements combined with human innovation to truly transform the PV landscape. Generative AI will be used to enhance user interfaces and make data more accessible to all stakeholders, empowering users to make better, data-driven decisions. However, to truly seize the opportunities on offer we need to make several key shifts. First, we need to make new technologies affordable so that all clinical trial partners can access the highest quality data. Second, we need to ensure we are constantly exploring which models are most effective to meet the challenges of modern clinical trials. Finally, we need to ensure we are training AI models with the right data and asking the right questions. 

Steve Rosenberg, CEO, uMotif 

15 years ago, the goal of ePRO was expected to be straightforward: The objective was to put paper forms on provisioned devices or mobile phones to lessen “parking lot syndrome,” enhance the patient experience, and improve data quality in clinical trials. Since that time, we’ve seen major changes in four key areas. First, clinical trial protocols are more complicated. Second, device definition has broadened beyond mobile phones and provisioned devices. Third, clinical trial participants have high expectations for technology; they expect to be able to use apps that are akin to those we use in daily life. Fourth, the site burden has increased. This changing environment demands an evolution of ePRO. In 2025 and beyond, ePRO must become more than the place where participants record their experience per the protocol. It must support all constituents that touch trial participants. Patient oriented ePRO means applications that support engagement and retention, deliver high compliance, and enhance the participant journey beyond data capture, with easy-to-use technology. Modern ePRO will also need to offer sites a more holistic experience. This means providing the tools, technology, and oversight to manage complex trials, all in one place. This includes the protocol, consent management – which sets the tone for the patient journey – records of the devices provisioned, and ways to manage hybrid trials (for example, organizing transportation for patients as needed). 

Bree Burks, Vice President, Site Strategy, Veeva 

Sponsors will step up to solve site capacity issues: Clinical research sites are the backbone of drug development. But, as the number of global clinical trials increases, the clinical site workforce is decreasing with high staff turnover rates. Complex protocols with multiple amendments and too many sponsor technologies per study are pulling site staff away from patients, limiting their capacity to take on more trials. As sponsors rethink their site engagement strategies in 2025, they will prioritize consistent site technology and standardization across sponsors for all trials. With 55% of sites reporting that their top challenge is supporting a variety of technologies, sponsors will drive standardization to avoid major slowdowns in their pipelines. The less time sites spend doing administrative work in systems, the more time they have to execute trials and help patients. This shift will help sites rebuild their capacity and ensure that drug development doesn’t stall. 

Drew Garty, Chief Technology Officer, Clinical Data, Veeva 

Underrepresented trial populations will get more choice: Patient enrollment and retention continue to challenge sites and sponsors, with trial complexity and patient fatigue contributing to high dropout rates. In 2025, sponsors that give patients more options for onboarding and trial visits will improve their experience and expand the participant pool to previously underserved populations. New FDA draft guidance on Diversity Action Plans urges sponsors to enroll more diverse patients and show the statistical breakdown of these groups in their trials. This will affect how data is processed and analyzed for submissions, to ensure enough clean data is available to meet statistical endpoints for each demographic subgroup. More patient options mean more data inputs and complexity. From monitoring subgroup enrollment and retention to data management and statistical analysis, unified data at the center will enable patient participation at the edges.