Clinical trial sites in Australia often face numerous challenges and extensive workloads during study start-up activities. These activities can be time-consuming, costly, and require significant allocation of resources. However, by contracting external vendors to handle study start-up activities, clinical trial sites can reap several benefits, including time, money, and resource savings. In this article, we will explore these advantages with examples and discuss state-level initiatives in Australia that promote the use of external vendors.
One of the primary benefits of outsourcing study start-up activities to external vendors is the significant time savings it offers. These vendors specialise in study start-up processes, allowing them to efficiently handle tasks that may take longer if tackled in-house. For instance, vendor expertise in protocol development, site identification, and regulatory submissions can expedite the process, reducing study start-up timelines by weeks or even months. By saving time, clinical trial sites can commence their trials sooner, accelerating the entire drug development process.
Contracting external vendors for study start-up activities can bring about significant cost savings for clinical trial sites. Instead of investing in establishing and maintaining an in-house team solely dedicated to these tasks, sites can leverage the expertise of specialised vendors on a project basis. This effectively reduces overhead costs associated with hiring, training, and retaining additional staff members. Moreover, vendors often have established relationships with third-party service providers, allowing them to negotiate better rates, resulting in additional cost savings.
Outsourcing study start-up activities frees up internal resources within clinical trial sites, enabling them to focus on other critical aspects of trial conduct. By utilising external vendors, sites can channel their human resources towards activities that require specialised expertise, such as patient recruitment, data management, and patient care. This allows for improved efficiency and ensures that resources are optimally utilised throughout the trial.
Australia has embraced state-level initiatives that promote the use of external vendors for study start-up activities. For instance, the New South Wales (NSW) Health Clinical Trials Framework encourages the use of contract research organisations (CROs) for clinical trial support services. The NSW Health Clinical Trials Handbook highlights the benefits of utilising CROs for study start-up activities, including improved consistency, efficiency, and reduced trial start-up timelines.
Additionally, the Victorian Comprehensive Cancer Centre (VCCC) Clinical Trials Network in Victoria offers support for clinical trial start-up activities, including site selection and feasibility assessments, protocol development, and regulatory submissions. The VCCC provides access to a recommended CRO list for clinical trial sites, further promoting the use of external vendors.
Contracting external vendors to handle study start-up activities in clinical trial sites in Australia brings several key benefits, including time savings, cost savings, and resource optimization.
The examples provided demonstrate the practical applications of these advantages, highlighting their significant impact on clinical trial site operations. Furthermore, state-level initiatives in Australia encourage the use of external vendors, emphasising the recognition of their benefits in streamlining study start-up processes.
NSW Ministry of Health. (2017). Clinical Trials Handbook.
Victorian Comprehensive Cancer Centre. (n.d.). Clinical Trials Network.