Feature|Articles|September 1, 2026

From Perspective to Action: Addressing the Real Cost Pressures in Clinical Trial Budgeting

Author(s)Tina Mincher, Shelley Douros

Static budgeting models and one-size-fits-all fair market value approaches create visibility gaps around inflation and true site costs, but regional frameworks, standardized costing toolkits, and accountability metrics can rebuild trust and replace defensive negotiations with transparency.

Building on the momentum from the Global Costing Task Force’s (GCTF) first article, Exploring Perspectives of Fair Market Value in Clinical Trial Budgeting, published in Applied Clinical Trials, the GCTF continues its mission to tackle the most pressing financial challenges in the clinical trial ecosystem. The initial article focused on understanding the differing perspectives of stakeholders: sites, sponsors, and CROs and highlighted how friction and mistrust often stem not from misalignment of goals, but from limited visibility into each other’s realities.

Related to this article

November 2nd, 2026

Embedding AI Across the Clinical Operating Model: Q&A with Rajneesh Patil, Syneos Health

In this Q&A, Rajneesh Patil, global head of AI, digital, and innovation in clinical development at Syneos Health, discusses what changes when AI is embedded across protocol strategy, data infrastructure, and workflow tools at once, where governance frameworks tend to fall short, and why CROs must orchestrate AI ecosystems rather than simply aggregate them.

© FlowStudio - © FlowStudio - stock.adobe.com

October 26th, 2026

Measuring What Matters: Realigning Clinical Endpoints with Patient Reality

Patients don’t experience primary endpoints, so trials that stop at biomarkers and rigid rating scales risk declaring success while leaving daily burden untouched, and digital tools only deliver meaningful evidence when they are co-designed with patients and deployed with restraint.

© putilov_denis - © putilov_denis - stock.adobe.com

October 21st, 2026

Obesity Is More Than Weight: Practical Approaches to Managing Comorbidities in Clinical Research

Pacing obesity trial enrollment, anchoring eligibility to stable real-world therapies, and building site and physician relationships improve retention and data quality more than aggressive recruitment or restrictive exclusion criteria do.

October 30th, 2026

What Needs to Happen Beyond the Clinical Trial Modernization Act

In this video interview, Kent Thoelke, CEO of Paradigm Health, calls for safe harbor protections, CMS reimbursement safeguards, and funding mechanisms modeled on EHR meaningful use to help community and rural institutions participate in research on par with academic centers.

October 29th, 2026

Building AI Assistants Clinical Trial Teams Can Trust: Q&A with E.K. Koh, Suvoda

In this Q&A, E.K. Koh, chief product officer at Suvoda, discusses what separates a trustworthy AI assistant from one that adds risk, why curated clinical knowledge matters more than general-purpose flexibility, and what safeguards must be in place when assistants move from answering questions to taking actions in clinical trial systems.

October 29th, 2026

How Embedding Research Into Routine Community Care Changes Who Gets Access

In this video interview, Kent Thoelke, CEO of Paradigm Health, explains why patients in community and rural settings too often lack access to clinical research as a care option, and how closing that gap could improve outcomes and lower long-term costs.

October 28th, 2026

Real-Time Continuous Trials Through the Lens of Risk-Based Quality Management: Why RBQM Is the Infrastructure RTCT Cannot Exist Without

The FDA’s RTCT initiative transmits predefined, clinically meaningful signals to regulators during active trials, so its value depends entirely on the maturity of sponsors’ upstream RBQM signal intelligence, KRIs, QTLs, and root-cause context, rather than on data speed.

October 27th, 2026

Closing the Medical Writing Capacity Gap: Why Training Beats Technology

Medical writing capacity pressure is fundamentally a talent development problem, not a technology problem, since hybrid resourcing and AI cannot substitute for the experienced judgment needed to review AI output and mentor the next generation of writers.