Key takeaways
Transparent FMV practices are critical: Open and collaborative FMV calculations help build trust and reduce negotiation friction among sponsors, CROs, and sites.
Flexibility drives site sustainability: Regional cost adjustments and dynamic FMV models are essential to fairly compensate diverse research sites and ensure their long-term viability.
Streamlined negotiation enhances trial efficiency: Unified budgeting tools and standardized contract templates can speed start-up timelines and improve trial management across multiple stakeholders.
Introduction
Effective financial management is a critical factor in the success of a clinical trial, and one of the most pressing challenges in clinical trial financial management is fair market value (FMV) and its application in research site compensation. Sponsors and contract research organizations (CROs) typically rely on tools to assess FMV, but the definition of FMV and what it should encompass can differ widely among stakeholders. Striking the right balance between fair compensation for the time, resources, and services provided by research sites and the operational costs incurred by sponsors has long been contentious, multi-layered, and complex.
This article aims to explore the complexities and varying perspectives surrounding FMV, with the ultimate goal of fostering mutual understanding and collaboration, improving budgeting practices, and strengthening relationships among sponsors, research sites, and CROs.
Preventing or mitigating these challenges is critical to the success of clinical research.
The Global Costing Task Force
To meet this challenge, Medidata’s Clinical Trial Financial Management (CTFM) team has brought together experts from across the industry, forming the Global Costing Task Force, whose mission is to optimize clinical trial financial management, driving efficiency, sustainability, and cost excellence in clinical research worldwide.
Fostering collaboration, sharing best practices, and leveraging technology, the Task Force seeks to empower industry stakeholders to make informed decisions, streamline operations, and achieve financial stability while considering environmental and social impacts.
The site perspective
For research sites, especially those operating as nonprofit or community-based organizations, FMV is more than just a number—it plays a critical role in ensuring their financial sustainability.
During discussions among the Global Costing Task Force, numerous site representatives voiced their concerns regarding the term FMV, shedding light on its complexities. Although FMV aims to establish a fair compensation framework for research sites, many find that it evokes negative sentiments tied to perceptions of undervaluation, inflexibility, and burdensome administrative requirements, as well as a disconnection from the actual costs incurred in conducting trials.
To effectively address these issues, a collaborative approach is essential—one that acknowledges the varied financial realities faced by different types of research sites in various countries. Sites must generate enough revenue from clinical trials to cover their essential expenses and maintain a high-quality research infrastructure. They face numerous financial pressures, including the costs of administration, staffing, equipment upgrades, regulatory compliance, and patient recruitment. Without adequate compensation, sites may struggle to participate in future studies or sustain ongoing research initiatives, regardless of whether they are nonprofit or for-profit organizations.
The findings of the Global Costing Task Force underscore the pressing need for a more nuanced understanding of FMV—one that takes into account the specific financial challenges faced by these critical partners. By encouraging open dialogue and collaboration among stakeholders, we can work toward developing FMV frameworks that better support the sustainability of research sites, ensuring they can continue to contribute to advancing clinical research and improving patient care.
From the site perspective, the following considerations are essential:
- Resource requirements: Sites must compensate trained personnel, such as principal investigators, study coordinators, and data managers. If budgets do not adequately and comprehensively cover all these directly trial-related costs, sites may shy away from resource-intensive trials.
- Geographic variations: The operating costs of research sites can vary considerably depending on their geographic location—both internationally and within individual countries. For instance, urban sites tend to experience higher expenses that are related to labor and real estate. These sites increasingly advocate for budgets and compensation packages that accurately reflect local market conditions.
- Overhead and infrastructure: Ongoing expenses related to maintaining facilities, technology, and safety standards are essential for ensuring quality research. While some sponsors may view these costs as excessive or the cost of doing business, they are critical for a site's operational viability.
- Sustainability: Research sites require sufficient revenue to balance clinical trial activities with their core healthcare services. Fair compensation allows them to fulfill their research commitments without compromising other responsibilities.
- Hidden site costs: It can be challenging to develop fair budgets for clinical trial sites because a significant amount of their work is not accounted for in the study budget. A more recent example is the need for sites to provide long-term clinical trial data storage, adding further burden and cost. While benchmarking tools aim to provide fair market value for protocol-required procedures, sites are often burdened with additional tasks essential for conducting trials—many of which go unacknowledged and uncompensated.
The sponsor perspective
For sponsors, FMV is not just a financial metric; it forms the foundation for their entire clinical trial budget and financial management. Sponsors must understand the intricacies of FMV to strike a balance between ethical compliance and effective cost management, to establish a crucial framework for justifying the compensation offered to research sites, to ensure adherence to regulatory standards, to preserve the integrity of clinical trials, and to mitigate any perceptions of financial inducement.
During discussions within the Global Costing Task Force, participants highlighted a significant challenge for sponsors: the necessity for FMV calculations to be transparent and consistent. Achieving this is vital for building trust among all stakeholders involved in the research process, including sponsors, sites, and regulatory bodies. When streamlining budgets across geographic regions, sponsors will often adopt templates and uniform country-specific FMV rates. However, sponsors also understand that a one-size-fits-all approach can overlook the unique financial realities of individual sites. Flexibility is needed.
Effective cost management is essential as excessive compensation rates can lead to budget constraints. At the same time, under-budgeting can result in insufficient resources to complete the study. Both hinder the development of new treatments since either scenario can jeopardize the financial viability of a trial, making it vital for sponsors to balance fair compensation for research sites with the need to maintain profitable operations.
For sponsors, adherence to FMV standards is not just a best practice; it aligns compensation practices with legal requirements. It is crucial for maintaining the ethical integrity of clinical trials, minimizing regulatory risk, and supporting the broader goal of advancing medical research. Compliance safeguards sponsors’ interests and reinforces the credibility and trustworthiness of the entire research process.
From the perspective of the sponsor, the following considerations are essential:
- Balance: FMV is much more than a financial metric and legal requirement. It is a cornerstone that influences every aspect of the clinical trial landscape. Understanding FMV intricacies is essential for sponsors to achieve a balance of ethical compliance and effective cost management.
- Standardization: To streamline budgeting across diverse regions and sites, most sponsors adopt standardized templates and country-specific rates to determine FMV. This approach is considered a best practice that facilitates predictable and flexible cost structures, simplifying financial planning and supporting efficient trial management. In practice, more flexibility is needed for diverse site and study-specific requirements.
- Regulatory compliance: Adhering to FMV standards is a legal requirement. Ensuring that compensation practices align with regulatory guidelines is also essential to maintaining the ethical integrity of clinical trials and minimizing regulatory risk.
- Budget control: Controlling clinical study costs to avoid overpayment and underpayment is critical for ensuring that resources are allocated efficiently and clinical needs are met. Budget overruns can threaten the financial viability of a trial, while under-budgeting can lead to insufficient resources and delayed timelines. Effective cost management requires finding the right balance.
The CRO perspective
CROs play a central role as intermediaries between sponsors and research sites, balancing the budgetary constraints of sponsors with the compensation needs of research sites. This critical positioning requires CROs to have a nuanced understanding of FMV to create budgets that are fair, align with regulatory expectations, and support efficient clinical trial operations.
Like sponsors, CROs use FMV frameworks and data to structure investigator grant budgets, streamline negotiations, reduce startup delays, and meet the needs of both sponsors and research sites. However, as for-profit entities, CROs must balance maintaining profit margins with ensuring the operational efficiency of trials. This makes FMV application crucial, allowing CROs to provide fair compensation while controlling costs. At the same time, CROs recognize their vital role in patient care. Clinical trials are not merely business transactions; they are essential to advancing treatments that improve patient outcomes. CROs must ensure research sites have the resources necessary to deliver high-quality care and safeguard patient safety. By collaborating with sites and ensuring adequate compensation, CROs help maintain trial integrity, prioritize patient well-being, and balance financial considerations with ethical responsibility, while contributing to the success and broader public health impact of clinical trials.
Global Costing Task Force findings highlighted the pressure that CROs face to initiate clinical trials quickly, requiring efficient negotiation processes to support fast study starts, streamline trial timelines, and optimize productivity. Quick, transparent negotiations are essential to meet the expectations of both sponsors and sites, especially in competitive trials or resource-intensive studies. To protect sponsors’ interests without compromising site viability, CROs conduct careful ongoing analyses of trial costs to ensure that compensation structures remain within budget limits. Cost efficiency is crucial to maintaining productive, positive relationships with both sponsors and sites.
In addition to financial considerations, CROs must also account for regulatory requirements, local market conditions, and stakeholder expectations. Effective communication with sponsors, research sites, and regulatory bodies is crucial to align expectations and address any FMV discrepancies that might arise. By fostering transparency and collaboration, CROs can build trust and contribute to smoother, more successful trial outcomes.
From the perspective of the CRO, the following considerations are essential:
- Alignment: CROs must align FMV calculations with sponsor budget constraints while ensuring fair site compensation. CROs often tailor FMV to reflect local costs and site-specific needs. Achieving this alignment is essential to balance sponsor expectations with site financial realities.
- Operational efficiency: To support efficient trial timelines, CROs must streamline budgeting and negotiation processes for faster study start-ups and consistent milestone achievement. A well-calculated FMV and early regulatory alignment help to expedite the process, reduce delays, and ensure compliance, ultimately enabling trials to progress smoothly and quickly.
- Sustainability: As for-profit organizations, CROs need to maintain sustainable profit margins while balancing the financial interests of sponsors and fair compensation for sites. Ensuring these margins is crucial for the CRO’s long-term viability and ability to deliver high-quality services.
- Communication: Clear communication about FMV fosters trust and alignment among CROs, sponsors, and sites. Transparency helps prevent misunderstandings, builds trust, and enhances the quality and reliability of clinical trial outcomes, benefiting all parties involved.
Summary of perspectives
The table below provides a high-level summary of the differing priorities, offering a clear and concise overview of how each group approaches FMV and other key aspects of trial budgeting and compensation.
Possible solutions
To address the challenges of differing perspectives on FMV, the Global Costing Task Force offers several strategies to help sponsors, research sites, and CROs achieve greater alignment. These recommendations aim to foster fairer, more transparent, and efficient budget practices across the clinical trial landscape.
1. Enhanced transparency in FMV calculations
- Open FMV methodology: Developing a standardized, transparent FMV methodology that clearly outlines how rates are calculated can build trust among all stakeholders involved in clinical research. Including a breakdown of all direct trial-related costs—such as site expenses, geographic adjustments, and regulatory compliance—enables research sites to better understand and accept budget determinations, reducing friction during negotiations.
- Collaborative rate setting: Establishing FMV rates with input from sponsors, CROs, and site representatives ensures that compensation better reflects actual costs and site needs, minimizing disagreements. Collaborative approaches can lead to more realistic FMV benchmarks that accommodate varying site financial realities.
2. Flexible budget models and regional adjustments
- Geographically sensitive budgeting: Given cost-of-living variations across regions, offering flexibility in budgeting can help sponsors and CROs tailor grants to reflect local market conditions accurately. Implementing location-specific FMV standards allows for fairer compensation, especially in urban or high-cost regions.
- Dynamic FMV models: Adjusting FMV frameworks to account for changing costs over time, such as inflation, labor market fluctuations, and technological advancements, can keep budgets realistic and prevent outdated rates from affecting site sustainability. This approach supports sites in maintaining operational quality over longer trial timelines.
3. Streamlined and collaborative negotiation processes
- Flexible standardized contracting and negotiation templates: Creating unified templates for contracts and FMV negotiations can accelerate the set-up process, reduce discrepancies, and enhance efficiency across multiple sites and trials. This standardization simplifies administrative efforts and reduces start-up delays.
- Centralized budgeting tools: Tools that centralize the budgets for sponsors, CROs, and sites offer a single source of truth, allowing for real-time access during negotiations. Such platforms facilitate smoother adjustments and reduce disagreements by making all FMV calculations visible and consistent.
4. Focus on sustainability and margin realism
- Sustainable profit margins for CROs: For CROs, balancing fair compensation for sites with sponsor budget limits requires careful attention to sustainable profit margins. Clear communication of the rationale behind these margins helps align expectations, reducing tension over cost allocations.
- Support for Non-Profit and Community Sites: Financial assistance programs or adjusted FMV considerations for non-profit and community-based research sites can help offset their unique financial challenges. This targeted support allows more diverse research sites to participate in trials without compromising their operational sustainability.
5. Enhanced communication and stakeholder education
- FMV education programs: Workshops or training on FMV principles and calculation methods can help all parties—from sponsors to site coordinators—understand each other’s financial and operational pressures. Greater awareness can foster empathy and collaboration, making FMV negotiations smoother.
- Open channels for ongoing feedback: Establishing regular forums for feedback on FMV policies and grant budgeting allows stakeholders to discuss challenges, share insights, and collaboratively adjust approaches. This continuous feedback loop supports ongoing improvement in FMV practices and fosters a culture of transparency.
Conclusion
The challenges surrounding investigator grants and FMV calculations in clinical trials reflect the unique perspectives and financial constraints of sponsors, CROs, and research sites. Through the work of the Global Costing Task Force, it’s evident that fostering better alignment across these stakeholders is critical to ensuring fair, sustainable, transparent compensation practices. By promoting open dialogue, regional adjustments, and a collaborative approach to FMV calculation, stakeholders can move toward a budgeting framework that respects the operational demands of each party while supporting the success of clinical trials.
As trials grow in complexity and geographic diversity, these solutions can help bridge financial gaps, reduce administrative burdens, and ultimately contribute to a more efficient research environment. Prioritizing shared understanding and adaptable FMV standards helps strengthen trust and build a more resilient foundation for clinical research that advances patient care worldwide.
Authors
Tina Mincher, director, client strategy, clinical trial financial management, and Shelley Douros, senior director, clinical trial financial management; both with Medidata
Contributors
- Antonella Chiucchiuini, director, fair market value lead, global medical evidence, Takeda Pharmaceuticals
- Asligul Kendirci, PhD, Pharm, president and founder, Ascot Science
- Daniel Fox, MPH, PhD, founder & CEO, Clinical Research Payment Network (CRPN)
- Prof. Edward Czerwinski, senior medical director at FutureMeds; founder (1995) and director of Krakow Medical Centre (up to 2020)
- Jay Panchmatia, senior site budget specialist, TFS HealthScience
- Jessica Cordes, senior consultant at Clinical Excellence GmbH
- Krystyn Adolphe, research strategy proposal developer, GC CRO
- Laura Bousfield, interim national research delivery director, NIHR Research Delivery Network
- Norman Goldfarb, executive director, The Site Council
- Robin Douglas, VP research site engagement, Medidata
- Ted Trafford, director of business Development, Probity Medical Research Inc.
- Thorsten Ruppert, PhD, senior manager research/development/innovation, vfa – German Association of Research-Based Pharmaceutical Companies
