Clinical Trial Budgets: Hidden Costs, Biggest Risks and Smartest Strategies — Lessons for Clinical-Stage Biopharma (an interview with Gary Quashie)
Written by the Pharma Business Conference Group (Clinical Outsourcing Group Series) on 27th February 2025
An exclusive interview with Gary Quashie, Senior Director of Business Development from Premier Research, conducted by David Jones, Head of Content at the PBC Group – organisers of the COG Series.
In this in-depth interview, Gary reveals critical insights on managing clinical research costs effectively. Discover how protocol amendments can increase expenses by 30-50%, why 80% of clinical trials face delays costing up to $8M per month, and strategies for avoiding the common pitfalls that lead to budget overruns. Sharing real-world examples of how poor budget management has resulted in company layoffs and discontinued medicines, while offering actionable solutions for patient recruitment, operational efficiencies, and vendor selection. Essential reading for clinical operations, R&D, procurement, and regulatory affairs professionals looking to accelerate innovation while controlling costs in today's competitive pharmaceutical landscape.
David: Gary, thank you for joining me today. Clinical trial budgeting is an area where many organisations face challenges. Could you start by explaining the real impact of poorly costed clinical trials?
Gary Quashie: Absolutely, David. Biotech, medical device and pharmaceutical companies are in a constant battle for funding. Every dollar matters when there's barely enough to get you to the end of the next trial. Burning through budgets too fast can have catastrophic consequences for organisations: failed medicines, massive staff layoffs, or selling the company at a severe loss. An overrun budget doesn't just cost experts their credibility; it can obliterate job security, devastate the careers of those around them and ultimately shatter the hopes of patients desperately waiting for new medicines. Costing a clinical trial is a high-pressure task with enormous implications.
David: Do you have any recent examples that highlight these consequences?
Gary Quashie: Yes, unfortunately there are several. Endpoint news recently highlighted a biotech that underestimated its Phase II cost by just 30%, leading to their stock plummeting by 50%, a frantic scramble for funding, and laying off 30% of staff before eventually discontinuing the medicine.
STAT news provided another example of a clinical operations VP that presented budget forecasts without accounting for site expansion. When costs rose by 20%, leadership lost confidence in their financial oversight and they were removed from their role.
David: That's quite sobering. How should experts approach learning from these situations?
Gary Quashie: It's important for experts to gain insights from industry developments wherever possible. Yes, clinical trials are incredibly complex projects, with each one needing its own distinct strategy. However, if there's one thing Colene Bentley's literature review on clinical trial costs has shown us, it's that there are distinct patterns between efficiently and inefficiently costed trials. Experienced clinicians always have a plan but are often shocked when they see how focusing in on specific areas can dramatically impact the cost effectiveness of their study.
David: What are some expected challenges that most clinical trials face?
Gary Quashie: Research from Cambridge Healthtech Institute shows that 80% of clinical trials experience delays ranging from one to six months. Only 10% are completed on time. When you consider that just a 1-month delay can cost $600k–$8M according to Clueo Clinical, you start to see how things can take a turn for the worst real fast.
It's clear that even the most experienced clinical experts face extremely difficult situations despite their planning. Sponsors can spend months or even years setting up sites, only for them to struggle with enrolment, leading to painful protocol amendments and senior management asking "why aren't we hitting recruitment targets" when you're already doing everything possible.
David: It sounds like challenges exist on both sides of the sponsor-site relationship.
Gary Quashie: Exactly. Many sponsors have experienced when sites stop answering calls and refuse to work because of slow payments or contract misalignments. Sites have experienced having to take on 3x the number of hours needed to fulfil tasks, only to end up not be paid. On all sides, people face challenges. Tools like the "Site invoiceables toolkit" from SCRC (Society for Clinical Research Sites) have helped bring clarity to clinical program budgets when it comes to hidden costs and potential hurdles for sites.
Experts like Gillian Sanders-Schmidler of Duke University and Roger Lewis from JAMA's guide to statistical analysis have talked publicly about creative ways to leverage incremental cost effectiveness ratios to decide on the best strategy to move forward with when comparing different options. Which can also help experts communicate to their senior management why more funding might be needed.
David: What would you say are the highest risk areas that can impact a clinical trial budget?
Gary Quashie: It's not just how you avoid potential hurdles but also having details contingency plans if/when bad situations occur. Risk mitigation plans need to be created and talked through with dry runs for various 'what if' moments. The five most high-risk areas that can most impact a clinical trial budget are: protocol amendments, patient recruitment and adherence, operational efficiencies or hurdles, partners/vendors, and those frustrating hidden costs.
David: Let's dive into these areas one by one. What can you tell us about protocol amendments?
Gary Quashie: Imagine, you've fought for every dollar, justified every line item, then 3 months into the study, a protocol amendment hits, and you've got another round of IRB approvals, site training and new contracts. Then your CFO asks, "why are costs increasing?" and just like that, you're back in battle mode struggling to salvage anything you can from poor data quality due to underfunded monitoring or data management.
Frustrating, so what do you do?
Ken Getz is well known for his Tufts CSDD study "The Impact of Protocol Amendments on Clinical Trial Performance and Cost," where they evaluated 836 Phase I-IV protocols. From his sample set, It seems half of all trials end up having a substantial amendment, and 45% of those are avoidable. Phase II & Phase III on average have 2 amendments. Usually, the larger the scope or longer the study/recruitment duration, the more amendments. Trials with fewer enrolled patients compared to the original planned number are also likely to have an amendment.
So it’s clear, statistically speaking, every trial should have planned scenarios for the most likely protocol amendments that could occur. Many specific events are unpredictable, but general themes can be anticipated. Especially for longer trials and anything related to patient enrolment/adherence. Cutting corners here often has consequences later.
David: That's remarkable. How long does implementing an amendment typically take?
Gary Quashie: In subsequent assessments by Ken Getz and his collaborators, we've seen that the total average duration to implement an amendment has tripled over the last decade. Time from first identifying a need to final approval on an amendment takes on average 260 days. The time in which different sites are found operating with different versions of the protocol typically spans approximately 215 days.
David: Are there any solutions to mitigate these amendment issues?
Gary Quashie: Start discussions as early as possible, especially with key opinion leaders, patient advocacy groups as well as the regulatory authorities. The NIH's rule of thumb is the fewer tasks/data points you have, the easier and cheaper the trial. Think particularly about your schedule of events as that drives per patient budget.
Plan multiple scenarios where you can potentially have contingency plans to handle rollout of an amendment if needed. Also, hybrid DCTs can be very cost effective if you're able to reduce the timeline of the study, otherwise you could be at risk of increasing the price (important to have clear idea of how DCTs impact the quality of endpoint data since it might be worth it). ). I’ve heard many people say it’s best to try to select standard of care imaging as it's often much cheaper/simpler down the line.
David: Moving on to feasibility and patient engagement—what challenges and solutions exist in this area?
Gary Quashie: Sponsors have seen it all before. Clinical sites fill out feasibility surveys swearing they can enrol 30 patients in 6 months. But 4 months later, they've screened two. And when sponsors/CROs chase them down, they say they're "working on it". Meanwhile, leadership is demanding answers and applying pressure.
David: How can sponsors address these recruitment issues?
Gary Quashie: Ask sites for actual patient data, not just estimates. Use site activation rates from previous studies to predict how fast they'll really start. Don't always go for the largest "best performing" sites. Mid-sized motivated sites often outperform high profile academic centres (less bureaucratic slowdowns and more priority on patient recruitment). Especially when properly supported financially.
Brainstorm options early regarding financial incentives, travel reimbursements, flexible scheduling and, digital recruitment methods. Social media and online platforms can be significantly more cost effective than traditional methods. Leverage patient advocacy groups to bring efficiencies to recruitment AND protocol development. If you must reduce number of patients in a controlled trial, consider historical control trials.
The amount of data available to create a thorough feasibility analysis is increasing every day. Find it and start planning as early as possible.
Bennett Levitan's "Assessing the Financial Value of Patient Engagement" paper describes how the cumulative impact of a $100k patient engagement plan that avoids just one protocol amendment, can significantly improve enrolment/retention/adherence, and result in an expected net present valuation (NPV) increase of $75M. A ROI exceeding 500x-fold. Clinicians shouldn't be afraid to ask their finance team to use risk-adjusted financial models to assess the value of their strategy and get approval for better budgets.
David: That's an impressive ROI. Let's talk about operational efficiencies. How can trials be streamlined?
Gary Quashie: Eric L Eisenstein et al's "Using Medical Informatics to Improve Trial Operations" shows how site-based costs account for 60%–75% of typical trial costs. By making better use of data science, eclinical systems and live reporting to all people up and down the chain, you can identify and implement important efficiencies.
Whether you like it or not, technology is transforming the clinical trials industry at a rapid rate and those who don't adapt will be less competitive, left lagging behind. Pew Research Center found that 40% of adults in the US have tried Generative AI. Change might be difficult, but investing well and early, like with anything in life, can set you up perfectly for the future.
It's 2025, use real-time tracking tools to monitor study startup delays and include regular infographic updates at the start of regular meetings to keep things under wraps. Hybridize your approach if you have experts in your team to help, just make sure you do lLeverage technology for cost efficiencies. It might initially seem tedious but EDC, & RBM tools help focus monitoring efforts on high-risk areas rather than full scale visits. Keeping tools few and simple does help reduce training costs at the site, but there are so many great tools out there that if you vet these vendors properly for their creative custom ideas and capabilities, then you will be pleasantly surprised with what you can achieve.
Look at the time it takes to complete each task, not just "who does what". Because sites have varied levels of resources and one way or another they will do what they need to do to accomplish a task.
David: When it comes to partners, especially CROs, what advice do you have for sponsors?
Gary Quashie: Not all CROs are created equal. The difference between the right CRO vs the wrong CRO can bring you great success or complete failure indefinitely. The right CRO is wants a good reputation and track record of successful projects in their portfolio. Naturally, they'll look for ways to answer questions before you need to ask them and will work together in a team with you. Pay close attention to your interactions with them and how they work with you. Not just for you.
But like most partnerships and relationships, you get what you put in. Have you shared ideas with your CRO on how to build efficiencies? Are you both spending time together finding ways to reduce project management hours? What incentives have you put into the contractual agreement (e.g. higher rates based on positive timeline achievements / volume discounts / milestones)?
Bottom line price is important, but a win-win can come in many forms. Keeping your plans/challenges secret from your CRO just means there's two organizations that might mess things up instead of one. What you want is one united front with expertise and resources working in sync to identify and solve issues. It's a competitive market, you don't always need the biggest or “most "experienced CRO", you need the CRO that will work together with you. Also, be diligent about companies switching the "A-team" out for a less competent "B-team" after a bid defence and ensure you have genuine access to the people at the CRO who will get things done for you.
David: What about contract negotiations with sites and CROs?
Gary Quashie: Non-refundable start-up fees, close out fees and change of monitor fees are becoming more and more common in site contracts. However, CROs & sponsors who haven't seen these before can have a hard time getting approval. It's hard enough keeping costs within specific parameters since investors don’t always give enough for a well run trial. So it gets scrappy sometimes. Finding ways to help each other and become a team of go-givers, rather than go-getters, can have a bigger more positive impact in contract negotiations for all parties involved.
Hind et al did a comparative cost study from a sample of UK clinical trial units and found a clear lack of consistency in "who does what" across different CTUs for all roles except statisticians and data managers. For example, if the site doesn't have ability to fund a formal quality assurance officer, they may need to get creative. Thus, selecting sites that you have experience with (or your CRO has experience with) can make for much more predictable results.
WCG 2025 "site challenges report" states 78% of sites experience delays due to poor communication with sponsor/CRO, and 65% of sites identify the lack of real time data access as a significant barrier.
David: Finally, let's talk about hidden costs in clinical trials. What should sponsors be watching out for?
Gary Quashie: It is widely reported that the most expensive “hidden” parts of a trial (excluding patient recruitment and areas highlighted above) are site + medical + safety monitoring and investigator grant payments, more so than IVRS costs, and IRB fees.
Keep a 15–20% contingency plan and discuss scenario planning for cost variations based on fixed vs variable costs.
5-10 hours of active work on contract negotiations at some institutes can materialize as 9-12 weeks on a timeline due to documents sitting in inboxes. Using templates where possible is key.
Decentralized clinical trials can create a lower cost, but patient tech support, wearables integration and regulatory processes can turn a simple Phase II into a logistical nightmare.
Translation & localization fees for ICFs, regulatory documents, patient materials and more can be shockingly expensive.
Investigator meetings & training costs across multiple regions add up.
Regulatory submissions and "once a month" ethics committee boards meetings can add significant costly delays to trials.
You've got to be careful of IMP (investigational medicinal product) supplies and logistics strategies. Lab kits, handling, storage, and distribution in certain regions/climates. These can can create significant issues especially at the start of your trial.
David: To wrap up our conversation, what final advice would you give to professionals about managing clinical trial costs?
Gary Quashie: Understanding these challenges isn't just for finance teams; R&D, Clinical Operations, Procurement, Regulatory Affairs etc. All teams play a critical role in managing trial costs effectively. To stay ahead, pharma professionals must adopt data-driven forecasting, negotiate smarter contracts, leverage technology, and plan for contingencies—all while ensuring compliance and trial integrity.
With market pressures mounting and competition fierce, those who master clinical trial cost management will not only control expenses but also accelerate innovation and bring life-saving treatments to market faster. In this high-stakes industry, knowing where every dollar goes isn't just important—it's essential for success.
Premier Research will be at COG UK, taking place on the 4th & 5th March 2025, in London. More information can be found here: https://www.thepbcgroup.com/cog-uk