Six ways to deal with rising clinical trial costs

Guest post by Safeer Khan, Lecturer at Department of Pharmaceutical Sciences, Government College University, Lahore, Pakistan

Introduction

In recent years, the cost of conducting clinical trials has risen dramatically. This increase has posed a significant challenge for pharmaceutical companies, researchers, and healthcare innovators. According to a study published in Nature Reviews in 2017, the median cost of conducting a study was $3.4 million for phase I trials, $8.6 million for phase II trials, and $21.4 million for phase III trials [1]. These rising costs threaten not only the financial health of companies but also the accessibility of new treatments for patients. Therefore, finding ways to address these cost challenges is critical for the future of drug development.

This blog will explore six proven strategies that can help pharmaceutical companies and researchers tackle the growing financial strain of clinical trials.

Streamline Study Design

The complexity of designs often contributes to increasing clinical trial costs. According to a study conducted by the Tufts Centre for the Study of Drug Development, more complex and burdensome protocols are leading to longer study cycle times and higher costs. There are several specific strategies that can be used to streamline study designs and reduce the increasing clinical trial cost.

• Minimize Patient Visits and Follow-ups: Reducing the frequency of in-person visits and follow-ups helps lower operational costs while still achieving the required outcomes.
• Optimize Sample Size: Traditional trials often overestimate participant numbers, leading to higher recruitment costs. Adaptive designs[2] allow for sample size adjustments based on interim data, enhancing cost-effectiveness.
• Focus on Key Endpoints: Limiting the trial to the most relevant endpoints reduces data collection efforts, saving both time and resources.
• Utilize Technology for Efficiency: Electronic Data Capture (EDC) systems streamline data collection, while cloud platforms facilitate real-time collaboration, reduce delays, and lower infrastructure costs.

Harness AI for Risk Management

AI is transforming the way clinical trials are managed, particularly in predicting and mitigating risks that can escalate costs[3]. By leveraging AI, pharmaceutical companies can take a more proactive approach, identifying and addressing risks before they cause significant disruptions or financial strain.

• Predict Potential Issues in Real-Time: AI-based Clinical Trial Risk Too analyze data from previous trials, patient characteristics, and ongoing study performance to flag associated risks. This allows for early corrective action, reducing delays that contribute to increasing clinical trial costs.
• Monitor Safety Concerns and Data Inconsistencies: AI can detect adverse events or data inconsistencies more quickly than traditional methods, enabling faster response times. This reduces the likelihood of costly regulatory interventions or trial halts due to overlooked issues.
• Optimize Resource Allocation: Predictive analytics powered by AI helps identify the sites, patient groups, or strategies most likely to succeed. This allows for more efficient trial execution ultimately saving time and money.

Shift to Decentralized Trials

Decentralized clinical trials (DCTs) are gaining traction as a way to reduce the costs and logistical complexities associated with traditional clinical trials [4]. The global DCTs market will grow from $9.53 billion in 2024 to $38.2 billion by 2034. Read more about: Decentralized Clinical Trials (DCTs) Market Size, Trends and Growth Factors. Regarding cost reduction, the key benefits of decentralized trials includes:

• Reduction in Site-Related Expenses: Traditional trials require physical sites, staff, and infrastructure, all of which add significant costs. DCTs rely on digital platforms, telemedicine, and remote monitoring tools, significantly reducing the need for physical infrastructure.
• Improved Patient Recruitment and Retention: In DCTs, patients are not required to travel to specific sites, overcoming a common barrier to participation. Virtual visits and remote data collection offer greater flexibility, making it easier to recruit a more diverse pool of participants.
• Streamlined Data Collection and Monitoring: The use of wearable devices and mobile apps enables researchers to monitor patient health metrics in real-time. This continuous monitoring reduces the need for in-person visits, leading to lower costs.

Improving patient recruitment and retention

Patient Recruitment Into Clinical Trials is the most expensive and challenging aspect, with recruitment costs accounting for 40% of the total budget. However, with improved strategies and innovative approaches, pharmaceutical companies can significantly reduce recruitment costs and enhance trial efficiency.

• Use Patient Registries and Databases: Patient registries and databases provide access to pre-screened individuals who have already expressed interest in participating in trials, reducing the recruitment burden. Integrating these registries with digital outreach can significantly speed up the process, cutting down on time and cost.
• Increase Patient Engagement: Maintaining communication and providing clear information about the trial process can help retain participants and prevent dropouts, which are a common cause of cost overruns. Tools like mobile apps and patient portals can help participants stay informed, making the process more convenient.
• Offer Flexible Participation Options: Addressing patients’ concerns and offering flexible participation options, such as remote visits or virtual consultations, can enhance recruitment and retention. The more accessible the trial is, the more likely patients are to enroll and remain in the study, ultimately reducing recruitment and retention costs.

Leveraging real-world evidence (RWE)

Real-world Data is quickly becoming an essential resource in clinical trials, providing valuable insights that can enhance trial designs, streamline patient recruitment, and ultimately lower costs. Some of the key benefits of using RWD to reduce the increasing clinical trial costs include:

• Enhanced Patient Recruitment: RWD enables the identification of larger and more diverse patient populations already integrated into the healthcare system, reducing recruitment time and costs.
• Optimized Trial Design: By analyzing RWD, researchers gain valuable insights into disease progression, patient behaviors, and treatment outcomes in real-world settings. This information helps refine the trial design, ultimately reducing unnecessary testing and sample sizes.
• Efficient Monitoring of Ongoing Trials: RWD allows for continuous monitoring of patient safety, treatment effectiveness, and emerging risks. This real-time data enables early identification of issues, allowing adjustments to trial protocols or patient criteria before costs escalate.

Stay Ahead on Regulatory Compliance

Regulatory compliance is an essential aspect of clinical trials, but it can also be a source of significant delays and cost overruns if not managed properly [5]. Staying ahead of regulatory requirements, therefore, is a critical strategy to avoid escalating costs.

• Timely and Accurate Regulatory Documentation: Ensuring that all regulatory documentation is accurately prepared and submitted on time helps prevent trial delays. Properly prepared documentation saves time and reduces the risk of fines or penalties due to non-compliance.

• Incorporating Regulatory Expertise Early: Understanding specific regulatory requirements for each stage ensures that trial design, data collection, and endpoints meet regulatory standards, preventing costly adjustments later that can extend timelines and increase expenses.

• Implementing Technology Solutions for Compliance: The use of electronic submission platforms, real-time compliance tracking tools, and automated reporting systems significantly improves the efficiency of clinical trial. These technologies reduce administrative burdens and provide real-time insights into the trial’s compliance status, helping to prevent delays and additional costs.

Conclusion

As clinical trials become increasingly complex and expensive, pharmaceutical companies and researchers must adopt innovative strategies to manage rising costs. Key approaches such as streamlining study designs, utilizing AI for risk management, adopting decentralized trials, enhancing patient recruitment, leveraging real-world data, and ensuring timely regulatory compliance can all play a pivotal role in reducing financial strain. Each of these strategies offers distinct benefits, from improving efficiency and patient accessibility to ensuring regulatory compliance, all while cutting costs. By implementing these effective strategies, pharmaceutical companies can not only lower trial expenses but also enhance the overall trial process, making drug development faster, more efficient, and more affordable for both researchers and patients.

References

1. Martin, L., et al., How much do clinical trials cost? Nature Reviews Drug Discovery, 2017. 16(6): p. 381-382.

2. Pallmann, P., et al., Adaptive Designs in Clinical Trials: Why Use Them, and How to Run and Report Them. BMC Medicine, 2018. 16(1).

3. Jain, S.S., et al., The Coming AI Revolution in Clinical Trials. Journal of the American College of Cardiology, 2025. 85(4): p. 378-380.

4. Van Norman, G.A., Decentralized clinical trials: the future of medical product development?∗._ Basic to Translational Science, 2021. 6(4): p. 384-387.

5. Lai, J., et al., Drivers of start-up delays in global randomized clinical trials. Therapeutic innovation & regulatory science, 2021. 55(1): p. 212-227.