3 Ways to Lower Clinical Trials Cost in 2024

Clinical trials trends in 2024 include management of trials for breakthroughs like personalized cancer treatments and advanced nanotechnology on the horizon. However, the journey through clinical trials presents significant financial challenge for many life science and biotech companies.

How much do clinical trials cost?

Clinical trials cost can vary significantly based on numerous factors, including the type of trial, its complexity, the number of participants involved, the duration of the study, and the geographic location. Generally, the expenses associated with clinical trials encompass a wide range of components, such as research staff salaries, administrative overhead, participant recruitment, site monitoring, data collection and analysis, regulatory compliance, and, in some cases, the use of specialized facilities and equipment.

On average, clinical trials can cost anywhere from a few million to several hundred million dollars. A Tuft’s University study showed that the estimated average cost per approved new compound in 2016-2017 was $1.395 billion. The Clinical Trial costs up to the point of marketing approval at a real discount rate of 10.5% amounted to $2.558 billion.

Phase I trials, which primarily focus on safety and dosage, tend to be less expensive compared to later phases that involve larger patient populations and more extensive data collection. The development of novel drugs or medical interventions typically incurs higher costs due to the rigorous testing and regulatory requirements.

Clinical Trial Cost per Patient

The highest clinical trial cost per patient was observed in the field of blood therapeutics, ranging from 200 thousand to 422 thousand U.S. dollars, with a median value of approximately 311 thousand dollars (2015 to 2017).

Navitas Life Sciences leverages its vast experience, expertise and advancements in technology to manage efficient clinical trials, reduce clinical trial costs and time to market.

Here are key ways pharma companies can lower their clinical trial costs in 2024:

1. Use of Digital Tools and AI in clinical trials for Clinical Trial Efficiency

In a recent study, 53% of participants expressed the belief that the greatest impact of AI/ML in clinical trials in 2024 will be on efficiency and outcomes.

The integration of artificial intelligence (AI) in clinical trials has resulted in a significant shift, particularly in enhancing clinical trial efficiency throughout the trial process. One of the primary advantages lies in streamlining of data gathering, leading to a significant reduction in trial periods and associated costs. By incorporating patient-focused methodologies, there is an improvement in compliance and participation rates, contributing to the overall success of clinical trials. The establishment of clearly defined decision-making criteria is instrumental in preventing the initiation of unproductive trials, thereby ensuring adherence to regulatory standards.

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Technological advancements, including electronic data capture (EDC), wearable devices, telemedicine, and AI, play pivotal roles in automating various aspects of clinical trials. Clinical Data Management Outsourcing can further leverage these technologies, reducing manual efforts and minimizing errors, fostering a more accurate and efficient trial environment. Electronic data capture systems with auto-completion features facilitate the automation of data entry, while predefined data cleaning routines handle missing values and outliers. The implementation of Risk-based Monitoring (RBM) utilizing statistical algorithms aids in the automated identification of potential risks, enhancing the overall risk management process. Data Management Staff Augmentation strategies can also be employed to ensure a skilled workforce is in place to manage and oversee these automated processes.

In the context of statistical programming, the use of version control systems ensure the integrity of the analytical process. The development of automated report generation, with dynamic reports populated from analysis results, enhances the speed and accuracy of reporting. Standardized analysis pipelines contribute to efficient data processing, further streamlining the statistical aspects of clinical trials. Clinical Data Management Outsourcing services can provide specialized expertise in statistical programming, ensuring that these processes are executed seamlessly.

In Clinical Trial Biostatistics, the incorporation of pre-built functions and libraries for statistical tests minimizes programming time and promotes consistency in analyses. Automated generation of tables and figures contributes to the uniformity and efficiency of reporting, while the implementation of adaptive trial design support through automated routines based on interim data analysis enables more agile and responsive trial strategies. Data Management Staff Augmentation can be a strategic approach to ensure that the biostatistical aspects of clinical trials are adequately staffed with skilled professionals.

The strategic inclusion of AI technologies, combined with Clinical Data Management Outsourcing and Data Management Staff Augmentation across these various facets of clinical trials, not only expedites processes but also enhances the overall quality and reliability of trial outcomes.

2. Decentralizing Trial Designs

Biotech companies are actively reducing clinical trial costs by integrating decentralization into their trial designs. Leveraging the lessons learned from the virtual care offered during the COVID-19 pandemic, companies are optimizing trial logistics by making meetings and evaluations as virtual as possible. Decentralized Clinical Trials extend to trial interventions, such as having mobile providers conduct blood draws or establishing a network of approved measurement companies throughout the trial region.

This decentralized approach reduces time and costs for patients, minimizing the risk of trial dropouts and increasing the likelihood of trial completion. It also results in cost savings for biotech companies by reducing the need for physical locations and working hours dedicated to data collection. Embracing decentralization is a strategic move that not only enhances patient convenience but also ensures long-term clinical trial cost-effectiveness

3. Clinical Trial Outsourcing

Clinical trial outsourcing emerges as a significant strategy for pharmaceutical companies seeking to enhance efficiency in their trial processes. Leading clinical research organisations(CROs)have a large patient database that they can utilize during clinical trials. Focusing on patient retention is a key element, as retaining participants minimizes the need for costly recruitment efforts and contributes to long-term participation, thereby improving data quality and reducing expenses associated with data cleaning. High patient retention rates also increase the likelihood of trial success, saving resources invested in unsuccessful trials. Collaboration with CROs proves instrumental in leveraging expertise, shared resources, and targeted patient recruitment. CROs play a crucial role in identifying and mitigating risks, facilitating global trials, and proposing adaptive trial designs for enhanced efficiency. Quality control measures implemented by CROs ensure data accuracy, accelerating time-to-market.

The implementation of adaptive trials, allowing modifications based on accumulating data, further optimizes efficiency in clinical trial processes. Additionally, initiating early collaborations with regulatory agencies is a strategic move, facilitating alignment on trial designs, endpoints, and requirements, thereby streamlining the regulatory approval process. A strategic outsourcing approach involves entrusting biometrics tasks to specialized vendors, such as CROs, for improved efficiency in data management and analysis. Moreover, involving patients in the development process by seeking their input on trial design and treatment expectations contributes to a patient-centric approach, fostering a more efficient and participant-friendly clinical trial environment.

Clinical trial outsourcing proves to be a multifaceted approach that significantly enhances efficiency and accelerates the drug development timeline for pharmaceutical companies.

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