KEY HIGHLIGHTS
- Frontier Science Scotland (FSS) was approached to fill capacity gaps for an academic clinical trials unit (CTU)
- Our decades of experience meant we could efficiently jump into different systems, a new disease area and new statistical theory
- We completed the work to deadline while following procedure and making improvements to the statistical programming
- The high quality of our work led to further commissions from the same academic CTU
THE BACKGROUND
Academic clinical trials units (CTU) work on early- to late-phase clinical trials and cover a broad range of diseases and treatments. These projects often influence national or international clinical practice, so they are highly regulated and must be carried out to a high standard.
THE CHALLENGE
An academic CTU commissioned FSS to fill capacity gaps for several projects at different stages in reporting. We were asked to provide statistical reporting for Independent Data Monitoring Committees (IDMC), safety reporting, deliveries for Steering Committees and data ready for Interim Analysis.
The projects had short deadlines, so our statisticians had to rapidly familiarise themselves with new systems and procedures, a new disease area and new deliverables, in order to deliver the required outputs on time.
OUR SOLUTION
Our biostatistics team was briefed on the disease area, the CTU team’s project infrastructure and statistical theory, and the Statistical Analysis System (SAS) coding, including macros. Due to our extensive experience of working with standard operating procedures (SOPs) and similar systems in statistical reporting and clinical trials, we quickly got up to speed. Working in collaboration with the statistics team at the academic CTU, our statisticians developed the reporting necessary for each deliverable.
THE OUTCOME
We carried out high-quality statistical reporting and supported the academic CTU with its capacity issues, delivering all the specified outputs to deadline. Improvements we made in the statistical programming enabled a smooth transition back to the CTU team once their internal capacity issues were resolved.
The success of this project has led to stronger collaboration between FSS and the academic CTU, and our biostatistics team continues to provide support on multiple new projects. On top of that, we have extended our support to include senior statistical oversight on several projects, with the scope to collaborate in other areas besides biostatistics.
If you would like to find out more about how Frontier Science Scotland can step in to support short- and long-term capacity challenges for clinical trials, please get in touch.
