Reducing Clinical Trial Costs in First-Time Clinical Trials

Launching a clinical trial is daunting for any pharmaceutical or biotechnology company, and even more overwhelming for those embarking upon their first clinical trial. The promise of breakthrough therapies tends to fuel enthusiasm, but overzealousness can cause missteps or incorrect decisions that can steeply increase clinical trial costs for sponsors. There is no singular way to run an efficient trial, no specific tool that can guarantee success. There are, however, several things to avoid if you’re looking to minimize costs in early-stage clinical trials.

In this article, we outline five common yet costly mistakes that routinely plague inaugural clinical trials and provide actionable strategies to help you steer clear of these pitfalls to optimize your trial outcomes.

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1. Inadequate Planning and Protocol Design

No clinical trial can be successful without meticulous planning and a carefully designed protocol. Failure to invest sufficient time and resources in into laying the proper groundwork can spell disaster, leading to delays and inefficiencies that will quickly increase clinical trial costs. Taking time to lay the proper groundwork for your clinical trial can help avoid these issues.

Thoroughly define endpoints - Ambiguity in clinical trial endpoints can derail an entire study. Ensure clarity and specificity in defining primary and secondary endpoints, aligning them closely with the therapeutic goals.

Diversify patient recruitment - Selecting the right patient population is necessary to achieve meaningful trial outcomes. Conduct comprehensive market research and engage with key opinion leaders to identify and target the appropriate patient cohort. Make sure to adhere to diversity and inclusion standards to ensure that differences such as drug metabolism, side effect profiles, and adverse reactions in specific populations will not be missed  which can cause complications for the trial down the road.¹

Determine the appropriate sample size - Consult with biostatisticians to calculate sample sizes accurately, to avoid compromising the budget or ethics of your clinical trial. Underestimating or overestimating the required sample size can skew results and undermine statistical significance. For example, a larger sample size ensures better representation of the population, yielding more precise results. However, once you reach a certain point, the added accuracy gained is minimal, and the extra effort and cost of recruiting more patients will add unnecessary expense to your trial.²

In contrast, a sample size that is smaller than necessary will appear to save trial sponsors on recruitment and management expenses but may compromise the study by offering insufficient statistical significance to answer the primary research question, thereby invalidating the study.  

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2. Regulatory Non-Compliance

Navigating the complex landscape of regulatory requirements is non-negotiable in clinical research. Failing to comply with local and international regulations can have dire consequences, including delays, increased clinical trial costs, and trial termination. Investing in proper trial oversight may require financial outlays throughout the trial, but can save your trial from protocol amendments, suspension, and termination.

Establish robust compliance processes to ensure ongoing compliance throughout the trial lifecycle. Assign dedicated personnel or teams responsible for monitoring regulatory changes, conducting internal audits, and implementing corrective actions as needed.

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3. Patient Recruitment and Retention Challenges

The success of a clinical trial hinges on timely recruitment and retention of qualified participants. However, nearly 80 percent of clinical trials are delayed due to recruitment challenges , leading to costly delays and increased expenses. First-time trial managers may not be able to avoid recruitment and retention challenges, but they can plan for them as best as possible, to mitigate risks and help keep things on track.

The first way to mitigate costs when it comes to enrollment is to set realistic projections. Overestimating projections can strain resources and lead to missed objectives. It's critical to conduct feasibility assessments and leverage historical data or predictive analytics to identify relevant recruitment areas and to establish enrollment targets that will be realistically aligned with study timelines.

Once you’ve established target patient communities, engage with them early to raise awareness and generate interest in the trial. Build relationships with physicians and health directors in your target communities and let them help you build trust and willingness to participate. This is especially important in communities where there may be skepticism towards clinical trials. Tailor recruitment strategies to target specific patient demographics and leverage diverse channels, including social media, patient advocacy groups, and healthcare providers. Most importantly, consider where your ideal patient base gets information, and make sure to promote the trial not just in every channel, but in the most relevant channels.

When it comes to patient engagement and retention, prioritize building meaningful relationships with trial participants. Taking a patient-centric approach may help by allowing patients to inform the way they participate so that it’s as comfortable and convenient for them as possible, which should help reduce dropout rates and mitigate the clinical trials cost per patient.³

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4. Data Quality and Management Issues

The integrity of clinical trial data is paramount for drawing valid conclusions and securing regulatory approvals. However, lapses in data quality and unreliable data collection and management techniques can undermine the credibility of study findings and incur significant costs, including prolonged Source Data Verification (SDV) time.

Standardizing data collection procedures and choosing the right data management tools to ensure accuracy and consistency can help keep your data accurate and properly formatted. Choosing a clinical trial data management provider that can automate the data collection and copying processes can help eliminate human errors and significantly reduce SDV time. The time-related cost per patient of manual data entry will also be significantly reduced. Likewise, choosing an EDC with auto calculations and edit checks can help you keep mistakes to a minimum and will save time on manual checks and calculations. If you are running your first trial, a significant advantage is that you may be able to have a say in which data management tools are used. While larger companies are often committed to older data management systems that are limited in functionality, first-time trial managers can take advantage of newer technologies that offer more robust, money-saving features.

No matter what data management system you use for your clinical trial, make sure to provide comprehensive training to site staff on data entry protocols and quality assurance measures. Establish rigorous monitoring and oversight mechanisms to detect and address data discrepancies as quickly as possible. Conduct regular site visits, employ remote monitoring procedures, and conduct regular data audits to identify potential issues proactively and implement corrective actions promptly.

Embarking on a first-time clinical trial journey is both challenging and exciting. By learning from some common mistakes, adopting proactive strategies, and making smart choices about how the trial is run, pharmaceutical and biotech companies can navigate these obstacles with confidence. Prioritizing meticulous planning, regulatory compliance, patient-centricity, and data integrity can help trial managers mitigate risks, optimize resources, and ultimately accelerate the development of life-changing therapies, all while minimizing the expense of your clinical trial.

1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9946429/
2. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6970301/
3. https://www.biopharmadive.com/spons/decentralized-clinical-trials-are-we-ready-to-make-the-leap/546591/