Cost of Clinical Trials: Where Overspend Happens and How To Curb It

Dec 2nd, 2025

Conversation around healthcare costs often centers on drug prices. What tends to be overlooked is the cost of getting a drug to market in the first place. Clinical development continues to be one of the largest and most variable cost drivers in the entire drug lifecycle.

A report from IQVIA reinforces this dynamic, noting that low growth in drug expenditure across many global markets is driven, in part, by intensified cost containment efforts. These efforts reflect a growing need to control costs throughout the development pipeline, particularly in clinical research.

Drug development remains an expensive and complex undertaking, but there are opportunities to reduce inefficiencies without compromising innovation. With tighter budgets and rising operational demands, understanding where clinical research dollars go and how to protect them is more important than ever.

Here are five of the biggest cost centers in clinical trials and practical ways sponsors, CROs, and sites can work together to control spending.

5 Areas Where Clinical Trial Costs Quickly Add Up

1. Patient Recruitment & Retention

Patient recruitment continues to be the most common and costly delay in clinical trials. Industry data suggests that nearly 80% of clinical trials are delayed due to recruitment challenges, with the average cost to recruit a single participant being more than $6,500. When patients drop out, the cost to replace them can soar to over $19,000 per individual.

Patient-facing issues like travel and visit frequency play a role, but protocol design and site engagement strategies are just as important. Poorly aligned eligibility criteria can limit real-world applicability and force sites to screen large volumes for few enrollments. Likewise, underestimating the complexity of long-term follow-up or minimizing the patient experience can result in higher attrition.

Ways to curb these costs:

Build patient-friendly protocols with realistic inclusion/exclusion criteria and flexible visit structures.
Select experienced sites with pre-qualified patient databases and proven retention strategies.
Implement tools like automated reminders, transportation assistance, and hybrid visit options to reduce burden.

2. Study Start-Up & Site Activation

For Phase I–III trials, the median activation timeline is 9.4 months at academic medical centers and hospitals — nearly double the 4.8 months seen at independent research sites and physician practices. That gap means time lost, alongside significant cost exposure as staff, vendors, and sites remain engaged without enrolling a single patient. In multi-site studies, staggered activations further delay enrollment curves, force the reallocation of resources, and increase pressure on already-tight development timelines.

The causes for activation delays are well known: prolonged contract negotiations, back-and-forth budget reviews, IRB submission delays, and lack of alignment across sponsors, CROs, and sites. Curbing these delays requires disciplined readiness with mutual accountability.

Ways to curb these costs:

Use central IRBs and master agreements to streamline regulatory and contract review cycles.
Select sites with demonstrated fast-start capabilities, including in-house regulatory and contracting staff.
Pre-position essential documents (1572, CVs, lab certs) and build shared timelines with accountability checkpoints.

3. Protocol Amendments

Protocol amendments are known budget-busters, and most of them are avoidable. According to a Tufts study, the average cost of implementing a single trial protocol amendment is $453,392 — and 34% of the amendments made were flagged as partially or completely unavoidable.

Amendments are sometimes necessary. Safety concerns, evolving standards of care, or emerging data can require changes midstream. But many amendments are driven by protocol overdesign or a lack of operational input during development. More thoughtful design up front reduces downstream trial rework and protects timelines and budgets from cascading effects.

Ways to curb these costs:

Involve sites and experienced investigators early in protocol development for operational feasibility input.
Limit nonessential endpoints and procedures to reduce participant and site burden.
Build in flexibility where appropriate (e.g., windowed visits, tiered criteria) to reduce amendment risk.

4. Monitoring, Data Collection & Management

As trials grow in complexity, so do the demands around data collection and oversight. Monitoring visits, source data verification, query resolution, and integration of multiple data systems can consume a large portion of a study’s budget.

When sites are juggling multiple platforms, sponsors may see inconsistent data quality, missed entries, or increased technical support needs. These issues are rarely the fault of any one party,

Ways to curb these costs:

Choose eClinical tools that integrate well and match the site’s operational capabilities.
Standardize monitoring plans using risk-based or centralized models where appropriate.
Prioritize vendor collaboration and site training to reduce query volume and maintain clean, timely data.

5. Trial Duration & Long-Term Follow-Up

Even when enrollment targets are met, trials can still run over budget due to long follow-up periods or delays in data analysis. Every additional month that sites remain open for extended patient visits, monitoring cleanup, or unresolved data queries means unplanned spend on staffing, storage, and operational overhead. In therapeutic areas requiring long-term observation like immunology, the cumulative cost of extended follow-up is often underestimated at study design.

Trial timelines also suffer when last-patient-last-visit dates are missed due to dropouts or site scheduling challenges. While some of these delays are unavoidable, many result from passive study management or unrealistic assumptions about site capacity.

Ways to curb these costs:

Monitor patient milestones and close-out readiness at the site level throughout the study.
Implement hybrid or remote visits to reduce follow-up burden for patients and staff.
Choose sites with strong patient engagement practices and a track record of clean, timely data submission.

When Clinical Trial Execution Improves, Costs Go Down

Drug development is a costly process and that won’t change overnight. But with more thoughtful planning, better collaboration, and smarter site partnerships, sponsors and CROs can minimize avoidable trial expenses and free up budget for bringing safe, effective, and affordable therapies to market faster.

At Remington-Davis, we’ve built our clinical trial operations with these very goals in mind: offering reliable patient engagement, fast startup capability, and flexibility that keeps trials on track and on budget. If you’re ready to rethink how your next study is executed, we’re ready to help.

Frequently Asked Questions About Drug Development Costs

What are the estimated costs of bringing a new drug to market?

Pharmaceutical companies can expect to invest between $1.3 and $2.8 billion to bring a new drug from discovery through approval. The clinical trial phases — especially Phase III and Phase IV — are among the most expensive stages of drug development due to their scale, complexity, and regulatory requirements.

What therapeutic areas are the most expensive in drug development?

In oncology, the cost of advancing new therapies is especially high due to the complexity of protocols, large patient populations, and extended timelines for follow-up — all of which reflect the broader challenges in innovating within cancer care. Neurology trials, such as those for Alzheimer’s or Parkinson’s, tend to be lengthy and require large sample sizes to account for variability in disease progression and treatment response. Meanwhile, rare disease trials often carry high costs due to limited patient populations, global recruitment needs, and highly specialized endpoints.

What role do CROs play in controlling clinical trial costs?

Contract research organizations (CROs) help pharmaceutical companies manage complex clinical trials by outsourcing key functions like site selection, monitoring, data management, and regulatory submissions. When well-managed, CROs can streamline trial operations and reduce costs related to overhead — but poor CRO oversight can lead to cost overruns and timeline delays.

How do pharmaceutical companies forecast clinical trial budgets?

Pharmaceutical companies and their CRO partners often use historical trial data, feasibility assessments, and country-specific benchmarks to forecast clinical trial budgets for a new study. Still, unexpected delays — factors like protocol amendments or slower-than-expected enrollment — often lead to budget revisions and added costs to getting novel therapeutic agents approved.

How do clinical trial costs impact the number of drugs approved each year?

Clinical trial costs play a major role in determining how many new drugs receive FDA approval annually. When clinical research costs balloon, pharmaceutical companies may shelve promising compounds due to budget constraints. High costs for drug development can also limit innovation to those drugs with blockbuster potential, reducing the number of treatments available for rare or less profitable conditions.