Creating a life-changing treatment requires comprehensive planning, meticulous execution, and substantial financial investment. Each phase of a product’s clinical development presents its own unique challenges and cost considerations, influenced by a myriad of factors such as trial size, scope, geographic spread, and duration.

Understanding these cost drivers is crucial to navigating the clinical trial landscape effectively, ensuring that your resource usage is optimized without compromising the integrity of your research.

From the initial safety assessments in phase 1 to the expansive efficacy studies in phase 3 and beyond, we’ll explore the elements that influence clinical trial costs by phase and discuss strategies for cost optimization.

Factors influencing costs

Before diving into the breakdown of clinical trial costs by phase, it's crucial to understand the key factors that can impact the overall expenditure of a clinical study. Most of these relate to the scale or scope of the study as larger, longer or more complex studies naturally incur greater costs.

• Number of assessments: The schedule of assessments within the protocol vastly impacts the overall trial costs. This includes the complexity of the assessments, and how often they are conducted. If there is a need for specialised equipment or certified staff members to perform the assessments, this will also drive up costs. Thus, it is paramount to include only the assessments needed to measure the efficacy and safety of your intervention, and to perform these at the most important timepoints. Wherever established standard of care can be applied, costs will be better controlled.
• Number of sites and participants: The number of trial sites directly influences costs related to site management, monitoring, logistics, and start-up. Similarly, recruiting and retaining participants incurs expenses, especially in trials requiring a large and diverse participant pool. In most cases the number of participants is calculated statistically so can’t be altered without impacting the quality of outcome. However carefully selecting sites and having back-up sites can help to manage costs.
• Number of countries: Conducting trials across multiple countries can increase the breadth and impact of your dataset, and reduce the time taken to recruit participants. However, it also presents a host of logistical challenges and regulatory complexities. Each country may have its own regulations, ethics committees, and languages, which contribute to increased costs. Additionally, costs associated with sample shipments and the logistics of supplying your product will increase with each added location.
• Time period of the study: Longer studies require sustained investments in resources, personnel, and infrastructure, which all impact costs. There is also a higher chance of participant drop-out with longer trials, which needs to be factored into overall participation numbers. An experienced CRO can help you carefully consider how long your trials need to be in each phase so you can progress more rapidly and manage costs carefully.
• The product: Lastly, the complexity of the intervention you are testing will impact costs. The greater the number of assessments that need to be performed, or the amount of data to be collected, and analysed, the longer your study needs to be, and the higher your costs.

Breakdown of clinical trial costs by phase

Pharmaceutical clinical trials are typically divided into four phases, each with its own distinct objectives, timelines, and cost profiles. Let's examine the cost considerations associated with each phase:

Phase 1

Phase 1 trials focus on assessing the safety and tolerability of a new intervention in a small group of healthy volunteers or patients. These trials are relatively short in duration but without the right processes in place, this phase can be expensive due to the intensive monitoring, and specialized facilities required to ensure participant safety.  Payments to participants also usually need to be factored in.

Phase 2

In phase 2 trials, the emphasis shifts to evaluating the efficacy of the intervention in patient cohorts with the target condition. Costs escalate as more participants are recruited, additional sites are activated, and data collection becomes more comprehensive. Where the intervention requires multiple doses, the phase 2 trials will almost certainly be longer than phase 1 trials.

Phase 3

Phase 3 trials are pivotal in demonstrating the effectiveness, and safety of the intervention in the target indication. A diverse patient population across multiple sites and regions is usually required. These trials are the most resource-intensive, involving large-scale recruitment efforts, extensive data collection, and rigorous monitoring to meet regulatory requirements.

Phase 4

Also known as post-marketing surveillance, phase 4 trials occur after the intervention has received regulatory approval for at least one indication, and is available on the market. While phase 4 trials are generally less expensive than earlier phases as they model standard of care and collect minimal data, they are essential for gathering real-world evidence on long-term safety, effectiveness, and cost-effectiveness of an intervention.

Opportunities for cost optimization

While the costs of conducting clinical trials can be substantial, there are several strategies sponsors can employ to optimize expenses without compromising the integrity or quality of the trial:

• Study design: This can include carefully designing the study to minimize unnecessary procedures, and leverage innovative trial designs such as adaptive trials. Streamlining the study design ensures the trial remains scientifically valid while avoiding non-essential expenses.
• Site selection and monitoring: Careful selection of sites based on their experience, patient population, and infrastructure can enhance efficiency and reduce unnecessary overheads. Additionally, implementing risk-based and/or centralised monitoring strategies can optimize resource allocation while ensuring data quality.
• Technology integration: Embracing technology solutions such as electronic Patient Reported Outcomes (ePRO), telemedicine, and remote monitoring can streamline data collection processes, minimize site visits, and enhance patient engagement, ultimately driving cost savings.
• Collaboration and transparency: Establishing collaborative partnerships with Contract Research Organizations (CROs), and other vendors can facilitate cost-sharing opportunities, and foster transparency in budgeting, and resource allocation.

If you want to learn more about how you can successfully navigate clinical research in Australia with a team of professionals committed to safe and ethical studies, get in touch with us today.

Southern Star Research is a full-service Australian Contract Research Organization. We help sponsors run safe and efficient trials that meet regulatory requirements, ensure scientific excellence, and demonstrate the commercial viability of your product. If you're looking for an agile and dedicated team to help you run a successful trial, contact us today.