Setting up Your Trial Endpoints for Success from the Beginning

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Running a successful clinical trial means successfully managing the full clinical trial supply chain.

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“Over the years, the clinical trial enterprise has been viewed as costly, inefficient and constrained by inadequate collaboration and insufficient utilization of technology, data sources and innovations in design and conduct. The COVID-19 pandemic highlighted many of these challenges, while also spurring the development of new approaches…A more robust clinical trial ecosystem that is capable of producing reliable evidence more efficiently may support more informed decision-making in developing medical products to help patients.” - Former FDA Commissioner Robert M. Califf, M.D., 2023 

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In this 2023 call for recommendations around modernizing clinical trials, former FDA Commissioner Califf proposed the establishment of a functioning clinical trial supply chain. But an efficient clinical trial enterprise with adequate collaboration and sufficient utilization of technology does not spring fully formed from the aether. Major retailers like Amazon and Walmart spend years and millions of dollars streamlining their supply chains, cultivating in-house expertise, and developing the external relationships needed to keep them operating smoothly. How can the small teams overseeing clinical trial logistics modernize their trial operations?

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A successful clinical trial hinges on smooth clinical trial supply chain management. Ensuring timely and accurate patient dosing while minimizing operational costs has only become more difficult as clinical trials become more complex and geographically dispersed. What are some best practices that can enhance your clinical trial supply chain management? 

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The Tools are Only as Good as The Teams

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Successful trial outcomes rely on seamless collaboration between the teams running the trial. One of the primary challenges we observe in clinical trial management is a disconnect between clinical supplies and clinical operations teams. Such a disconnect between teams can lead to misaligned expectations and logistical inefficiencies. 

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One signal of potential conflict between teams is the language they use to describe their process. For instance, if a clinical operations team refers to a trial site as belonging to them (“my sites” or “our sites”), it exhibits an exclusionary mindset, and sets the clinical supplies team apart in a potentially adversarial relationship. 

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Clinical supplies and operations teams need strong collaboration along the entire journey of the clinical trial. They must align their goals and understand the impact of site performance on clinical trial supply chain forecasting. A collaborative approach can help both teams address challenges proactively and invest more deeply in the success of the trial.

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Leveraging your RTSM System and RTSM Partner for Improved Supply Chain Management

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Randomization and trial supply management (RTSM) technology plays a critical role in streamlining clinical supply chain processes, but even a built-for-purpose RTSM system like Endpoint’s is not an off-the-shelf panacea for logistical headaches. RTSM technology is only part of the solution. Setting up your RTSM to meet your needs requires careful, early planning and integration with your other eClinical systems. An RTSM partner with decades of experience supporting clinical trials, high-touch quality management, and tech-forward innovation is your hidden advantage for getting the most out of your RTSM system.

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Here are a few best practices for implementing your RTSM system:

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• Early Involvement: Engage your RTSM partner early in the trial design process to avoid delays and ensure seamless integration. Early involvement allows for better alignment of technology with trial protocols and operational plans.

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• Clear Specifications: Provide detailed specifications to avoid misinterpretations. Specify exactly how you want the system to function, including sorting criteria and error handling. 

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• Site Feedback: Incorporate feedback from clinical sites into the system design. Sites are the primary users of RTSM systems, and their input can lead to more intuitive and user-friendly systems. 

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Standardization and Data Management

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By standardizing processes and system functionalities, you can minimize the need for constant customization and ensure consistent performance across multiple trials. 

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Here are a few strategies for effective standardization: 

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• Standard Processes: Common tasks such as patient screening, enrollment, drug dispensing, and data collection benefit from standardization. In addition to reducing the need for labor-intensive customization, it simplifies training for site personnel. 

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• Data Integration: Define data points upfront and establish how they will be managed throughout the entire supply chain across different platforms. This can minimize reconciliation issues at the end of the trial.
  
  
• Regulatory Compliance Alignment: Ensuring that system functionalities and data processes align with global regulatory requirements (e.g., ICH-GCP, 21 CFR Part 11, GDPR) streamlines compliance efforts and minimizes the need for region-specific adjustments.

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Risk Management and Contingency Planning

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Clinical trials are awash in uncertainties, from treatment efficacy and side effects to whether or not a patient’s insurance will cover the trial and if patients will adhere to treatment plans. Anticipating these potential risks and planning accordingly can help you avoid disruptions and ensure smooth trial operations. 

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Here are a few risk-management strategies: 

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• Proactive Planning: Consider the potential scenarios you could be facing during the trial period, such as changes in patient enrollment rates, protocol amendments, changes in governmental administrations, and other potential geopolitical events. Developing contingency plans for even a few of these scenarios will help you manage risk with any other unforeseen scenarios.

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• Dynamic Forecasting: Static forecasts can lead to inefficiencies and stockouts. Work with your RTSM partner to incorporate real-time data and adjust your forecasts accordingly. Regularly update your supply chain forecasts to reflect changes in trial conduct. 

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• Supply Chain Contingencies: Unexpected disruptions—such as manufacturing delays, shipping restrictions, or temperature excursions—can impact drug availability. Establish backup suppliers, maintain buffer stock levels, and implement alternative distribution strategies to ensure uninterrupted trial operations.

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Enhanced Site Experiences

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Clinical sites play a crucial role in the success of clinical trials, and their experiences with technology and supply chain processes can significantly impact trial efficiency. Listening to site partners, incorporating site feedback into system design, and providing adequate training can all improve site compliance and data accuracy. 

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Here are a few ways to improve site engagement: 

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• User-Friendly Systems: Work with your RTSM partner to design systems that are intuitive and easy to use. Complex and cumbersome systems can lead to errors and frustration among site personnel. 

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• Clear Communication: Provide clear and concise instructions to sites on how to use the systems you put in place. Regular training sessions and support can help address any issues and ensure smooth operations.
  
  
• Ongoing Support & Feedback Loops: Foster continuous engagement by providing sites with dedicated support channels and actively seeking their feedback. Regular check-ins and system updates based on site input can enhance usability and compliance.

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Endpoint is your Hidden Advantage 

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With expert knowledge of both software and trial protocols built on years of experience in the clinical trial space, choosing Endpoint Clinical as your RTSM partner can help you design an RTSM system that meets your needs and improves your clinical supply chain management. Working alongside your own in-house experts can ensure that your systems are designed to meet trial needs and can adapt to study changes seamlessly. 

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Reaching your trial endpoints hinges on successful clinical trial supply chain management–good planning, strong relationships with your sites, and leaning on your RTSM partner to get the most out of your RTSM system. 

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By bridging the gap between clinical supplies and operations teams, standardizing processes, leveraging expert insights, and incorporating site feedback, you can enhance trial efficiency and ensure successful outcomes. 

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The choices you make from the beginning of a study drive your success at every endpoint. By starting with Endpoint, you’ll have a layer of stability, support, and trust you can count on throughout your trial. 

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Schedule a demo with Endpoint Clinical to learn more about how our solutions can set up your clinical trial endpoints for success from the beginning. 

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