In clinical trials, randomization and trial supply management (RTSM) solutions help randomize the participant allocation and ensure the study design is balanced and trial supplies are available when and where they are needed. A key piece of those efforts is the use of interactive response technology (IRT) software.
Traditional RTSM study build processes follow a sequential, waterfall approach that can be time-consuming. Business analysts work with vendors to write study requirements and specifications, followed by a build phase to implement those requirements. A final validation phase verifies the requirements.
Vendors have attempted to streamline these processes using web-based configurations that allow companies to quickly set up trials. Some of these tools allow studies to be set up without custom coding, eliminating the extensive development time needed to write new software for every individual study. However, creating lengthy specification documents prior to the study build can create inefficiencies, generate unnecessary customizations and lead to significant re-engineering of the study after the testing phase.
Current approaches to IRT based on traditional methodologies can introduce extra costs, time and errors into the study build process. A new, more agile approach that involves customers earlier in the development cycle can result in improved quality, faster deployments and lower overall costs. This agile approach, which is based on existing agile software development methodologies and principles, can reduce the back-and-forth that occurs during the user acceptance testing (UAT) and quality control (QC) phases.
The agile model promotes adaptive planning, evolving development and the use of functional software in vendor/client interactions rather than the development of specification documents prior to the study build. The client can evaluate this software demonstration and provide immediate feedback that can then be used to rebuild the study. And while there may be some cost associated with that rebuild effort, the cost is relatively low—low enough that the specifications don't have to be perfect in advance of the study build. Once the build process is complete, the final specifications can be constructed to align with the as-built study exactly, which results in a faster sign-off and approval process.
The agile approach not only improves the efficiency of the process, but ultimately results in a higher-quality study. By streamlining the process and getting clients involved earlier, the following benefits can be realized:
1. High Efficiency and Quality
While an agile IRT approach does make the build process faster, speed is not necessarily the primary driver. The real benefit to an agile approach is that it improves the efficiency of the entire process: The time spent building the study is much more productive, and there is less waiting between process steps. It also improves the quality of the finished product because the team can focus on problem-solving rather than the development of intricate specifications.
2. Earlier Problem Resolution
With the software right in front of them, the study team can immediately spot mistakes or identify incorrect assumptions they made early on in the process about the structure of the system. They can also avoid overlooking flaws in the study that might otherwise be missed in UAT.
3. Faster Project Completion
The study can be configured much more quickly, which can significantly reduce study build time. While a standard study traditionally takes six to eight weeks to build (that can stretch out to 12 weeks for a more complex study), an agile approach can often be completed in much less time, from kick-off to first patient averaging five and a half weeks.
4. Reduced Customization
Clients also have an opportunity to see that the core configurable IRT system can often meet most of their needs without a high level of customization—something that isn't necessarily clear when they work on lengthy specification documents. By seeing how the system can work early in the process, they can visualize how the solution can meet their needs, even if it does so in a way that had not occurred to them before. A reduction in customization not only translates to a quicker and lower-cost build, but it can also reduce the complexity of building and maintaining the IRT study throughout its lifetime, and therefore lower risk of error.
5. Fewer UAT Findings
The collaboration enabled by agile IRT should result in a UAT phase with fewer findings and less redevelopment. This further streamlines the process because clients don't have to dedicate resources to testing for lengthy periods of time.
6. Reduced Time Investment
The client spends less time working on the study build process. While an agile approach requires a greater level of collaboration and availability on the part of the client, it ultimately reduces their investment in time and resources by reducing the effort required for multiple rounds of specification development and multiple UAT cycles. A higher-quality study also reduces the maintenance effort required to run the study.
IRT software has helped streamline and simplify the RTSM process, but the reliance on developing lengthy specifications documents prior to the study build adds time and cost that can be avoided by improving collaboration between researchers and the study build team. Agile IRT can reduce the cost and time required for the study build process while also leading to a higher-quality study with fewer UAT findings. This approach makes it more likely that the study will meet the study team's requirements, with a lower investment in time and resources.