Five Predictions for Clinical Research in 2025

The clinical trial industry is shifting from incremental process improvements to foundational change. Financial workflows, participant engagement, and protocol design are no longer back-office concerns – they are now strategic levers that will determine which sponsors and CROs can run faster, more efficient, and more inclusive trials.

Sponsors that embrace modern financial enablement, AI-driven operations, and real-time participant insights will reduce trial timelines, optimize site engagement, and increase regulatory success. Those who fail to modernize will see rising costs, slower enrollment, and greater regulatory scrutiny.

Here are five predictions for 2025 that will reshape the future of clinical research that you and your teams should consider:

‍

1. Participant financial enablement will become a competitive advantage for sponsors

For years, participant stipends and reimbursements have been treated as a compliance checkbox rather than a strategic tool. Most trials still rely on slow, outdated payment systems that introduce friction – delaying reimbursements for weeks or months and leaving participants to bear the financial burden of trial participation.

This approach is no longer sustainable, and financial enablement is rapidly emerging as a core differentiator for sponsors – particularly in trials with specific participation requirements, heavy burden, or significant travel needs. The data paints a clear picture of the current crisis: A 2023 CISCRP study revealed that 65% of participants cite financial concerns as their primary barrier to trial enrollment. The problem is exacerbated by outdated payment processes, with most sites still relying on manual systems that take 14-30 days to process reimbursements. The impact is severe: dropout rates reach 30% in some studies, with each participant withdrawal costing sponsors approximately ~$20,000 in replacement recruitment costs.

The industry stands at a turning point, driven by both necessity and regulatory evolution. The proposed Harley Jacobsen Clinical Trial Participant Income Exemption Act signals a transformative shift in how stipends are taxed, potentially removing a critical financial barrier for underrepresented populations. In response, forward-thinking sponsors are revolutionizing their approach - implementing real-time, fee-free payments, pre-paid travel budgets, and comprehensive financial support that goes well beyond basic stipends. This shift is more than a compliance measure; it's becoming a powerful recruitment tool and competitive advantage.

Our take: By the end of 2025, at least one major pharma company will state participant financial enablement as a priority – not for compliance, but to improve trial efficiency.

‍

2. The industry will finally embrace transparent site budgeting

Site budgeting has long been a slow, opaque process, with high variability in site payments, long negotiation cycles, and little real-time visibility into costs. Most budgets today are negotiated in silos – sponsors lack accurate benchmark data to compare site costs, and CROs rely on legacy processes that introduce inefficiencies.

These inefficiencies have consequences. 40% of trial startup delays are directly linked to budget and contract negotiations, with the average site contract negotiation taking ~230 days according to Tufts CSDD. These delays cost sponsors an average of $500,000 per day in unrealized drug sales and $40,000 per day in direct clinical trial costs for a potential drug candidate. In some cases, negotiations stretch beyond this, delaying first-patient-in (FPI) timelines and increasing overall trial costs.

Sponsors are now recognizing that budget transparency is not just a finance issue – it’s a trial acceleration lever.

In 2025, expect to see:

• Sponsors benchmarking site budgets in real-time to identify and correct inefficiencies.
• AI-powered financial modeling that predicts site cost variability and adjusts budgets dynamically.
• Faster, more standardized budget approvals, reducing trial startup delays by months.

While some stakeholders may resist this shift, forward-thinking organizations will embrace budget transparency as a way to improve site engagement and optimize trial execution.

Our take: By the end of 2025, the first fully AI-driven budget negotiation system will see initial adoption, demonstrating the potential for trial financial planning to move from months to weeks.

‍

3. The FDA will require real-time participant experience data in regulatory submissions

The FDA has increasingly pushed for trials to be more patient-centric, more diverse, and more representative of real-world populations. In 2023, the agency issued guidance on Diversity Action Plans, requiring sponsors to proactively track recruitment efforts across demographic groups.

The next step? Mandating real-time participant experience data as part of regulatory submissions. Historically, sponsors have relied on patient-reported outcomes (PROs) and post-trial surveys to assess participant burden. These methods are inadequate – data is collected too late to inform trial adjustments, and retrospective reporting introduces bias.

Industry data shows that the vast majority of trials still rely solely on end-of-study participant surveys, with only a small fraction implementing real-time feedback collection systems. The consequences are significant: according to Tufts CSDD, protocol amendments – many driven by participant-related challenges that could have been identified earlier – cost sponsors between $141,000 to $535,000 each and typically add 3 months to development timelines. These delays and costs could be substantially reduced through proactive, real-time participant feedback systems.

Under the current administration, with Robert F. Kennedy Jr. as the Secretary of Health and Human Services and Dr. Marty Makary as the FDA Commissioner, there is an even stronger emphasis on data-driven, patient-focused regulatory practices. Both leaders have expressed a commitment to enhancing the quality and transparency of clinical trial data, aiming to ensure that drug approvals are firmly rooted in comprehensive participant insights.

In 2025, we predict the FDA will take a more aggressive stance on patient experience data, pushing for:

• Real-time collection of participant-reported burdens, such as financial strain, travel difficulties, and site interactions.
• Data standardization, ensuring participant insights are collected in structured formats that can be analyzed at scale.
• Regulatory consequences for sponsors that fail to demonstrate patient-centric trial design.

This shift will be a wake-up call for sponsors that still rely on static trial protocols without real-time participant engagement.

Our take: By the end of 2025, expect the FDA to publicly delay or reject a high-profile trial submission due to insufficient participant experience data – accelerating a broader regulatory shift toward real-time patient burden monitoring.

‍

4. AI will finally have a measurable impact on clinical operations – not just drug discovery

AI has been overhyped in drug discovery but underutilized in clinical trial execution. In 2025, we believe that will change. Until now, AI has primarily been used to identify drug targets, predict molecule interactions, and optimize trial site selection. While these applications remain valuable, the biggest operational gains in 2025 will come from AI-driven trial execution. Current data shows only 20% of sponsors utilize AI for operational optimization, despite the majority of sites expressing interest in AI-driven trial execution tools.

Early adopters are proving the transformative potential of AI in clinical operations. AstraZeneca has partnered with Oncoshot to streamline patient-to-trial matching using AI, while Sanofi has invested $180 million in its alliance with Owkin to integrate AI-powered biomarker discovery and trial optimization into its oncology pipeline. Pfizer has similarly embedded AI into its clinical development processes to accelerate timelines and improve trial efficiency. These efforts reflect a broader industry shift: a recent McKinsey report found that sponsors using AI-driven trial execution have achieved 30-50% improvements in site selection accuracy and a 10-15% acceleration in enrollment timelines. Generative AI is driving additional gains – tools like auto-drafting trial documents have cut process costs by up to 50%. In some cases, optimized site selection and AI-assisted decision-making have compressed trial timelines by more than 12 months.

These early successes in protocol compliance and site productivity signal a clear trajectory for the industry. By 2025, expect to see:

• AI-powered enrollment optimization, where machine learning dynamically adjusts recruitment strategies based on real-time data.
• Dropout risk prediction models, enabling sponsors to intervene before participants disengage.
• Risk-based monitoring driven by AI, reducing unnecessary site visits and improving trial compliance.

Leading sponsors will no longer rely on manual processes for patient retention, site performance monitoring, or enrollment forecasting. Instead, AI-driven tools will proactively identify risks and optimize trial operations.

Our take: By the end of 2025, at least one major sponsor will announce an AI-driven clinical operations overhaul – cutting trial timelines by 30% or more.

‍

5. AI will reshape protocol design – shifting the industry from “predict and plan” to “adapt and optimize”

Protocol amendments remain one of the most significant challenges in clinical trials, with substantial cost and time implications. A single amendment can increase trial costs significantly, though the exact percentage varies. According to a Tufts Center for the Study of Drug Development study, the median direct cost to implement an amendment is ~$141,000 for a phase II protocol and ~$535,000 for a phase III protocol. Despite this, protocol design remains a static process, where assumptions are locked in before a trial even begins.

This will change in 2025. Instead of relying on rigid, pre-planned protocols, sponsors will begin to adopt AI-powered adaptive trial models, where:

• Protocol feasibility is tested in real time, reducing mid-trial amendments.
• Eligibility criteria adjust dynamically, based on real-world participant data.
• Dosing schedules and visit structures evolve, ensuring optimal patient engagement.

This shift will be particularly impactful in complex therapeutic areas such as oncology and rare diseases, where protocol flexibility can dramatically improve patient recruitment and retention.

Momentum is already building: The FDA has already proposed frameworks to enhance the credibility of AI models used in drug and biological product submissions, signaling regulatory readiness to evaluate AI-powered protocols.

Our take: By the end of 2025, the first fully AI-optimized trial protocol will be approved by a major regulatory agency – demonstrating that clinical trials can be both flexible and rigorous.

The predictions outlined here are not theoretical—they are emerging realities that will define the future of clinical research. Financial workflows will become strategic levers. AI will reshape trial execution. Regulatory bodies will demand more from sponsors. The industry’s next phase will belong to those who move beyond compliance-driven models and take proactive steps to design faster, more flexible, and more patient-centric, inclusive trials.