Brief overview of Catherine’s research
My research investigates how we can assess the impact of oncology clinical trials. It is important to be able to demonstrate that trials testing new oncology treatments are having real life impacts such as changing practice, changing health and saving money. Analysing this impact helps us to identify which trials are making real world differences, and subsequently, to design more impactful trials in the future.
I am conducting a case study to assess the impact of the Short Course Oncology Treatment (SCOT) trial (1). This study investigated if treating patients with a diagnosis of colorectal cancer with 3 months of chemotherapy following surgery was non-inferior to treating with 6 months of chemotherapy. The trial results have shown that giving a shorter duration of treatment does not make a significant difference to the percentage of patients who are disease free at 3 years. Patients in the 3 month arm of the trial also had significantly less side effects from the treatment, especially with regards to peripheral nerve damage.
Gaining access to GGC Chemocare data, linked to QPI and SMR06 data sets, has enabled me to assess the impact of the SCOT trial on changing clinical practice. There was a significant change in prescribing practices for patients with colorectal cancer after the results of the SCOT trial were publicised. This will translate to a cost saving for the GGC health board and will result in less patients in GGC experiencing debilitating peripheral nerve damage as a result of their adjuvant chemotherapy treatment. A poster with the preliminary results of this analysis was presented at National Cancer Research Institute 2018.
In the next stages of my project, I plan to investigate the impact of the SCOT trial on prescribing on a national scale by using routinely collected chemotherapy data from the three cancer networks in Scotland (South East Scotland (SCAN), West of Scotland (WOSCAN) and North of Scotland (NOSCAN)). My project is running alongside, and will be using a sub-set of, the COloRECTal Repository (CORECT-R) data at the University of Edinburgh (part of an even wider project at the University of Leeds). PBPP approval for my project was granted in June 2018, however, I do not yet have access to this data. Below, I outline some of the lessons I have learned during the application to access this national data.
Summary challenges faced
(1) When data is on databases out with Information Services Division (ISD), often at a local or regional level, this makes the process of data linkage more challenging and costly. Often, there is not the expertise at a local level to extract and transfer data and working relationships between local analysts and those coordinating data linkage centrally do not exist. Specifically, there are few examples of previous linkage of chemotherapy prescribing data (held locally) on a national scale.
(2) Data linkage requires a pre-specified list of the data variables from each data set. Often these lists are not publicly available, or even defined, and it can be time consuming and difficult to generate variable lists which are required for the data linkage process.
(3) Evidence of funding to perform data linkage and make use of national linkage services is often required for PBPP approval. However, depending on the time between submission and the data linkage occurring, it can be several years before the funds are used.
(4) If a researcher is funded for a specified period, the time taken for PBPP approval and data acquisition means that the researcher may not have an opportunity to analyse the data. There is also a risk that the research question will be less relevant than at the time of submission.
There is huge potential to use routine data to improve the way we do clinical trials and ultimately to improve outcomes for patients. The potential to pioneer the use of routine data for research purposes in Scotland is obvious; however, the practicalities of currently accessing and using this data are not straightforward.
My advice for anyone planning to work with national Scottish data, based on my experience:
- Apply for access to data early and be aware that data acquisition may take longer than expected depending on your project.
- Think about the costs of data linkage, especially if you want to link data sets that are not currently stored in ISD. The size and subsequent cost of a data linkage project is often based on the number of databases used (especially those outside ISD), rather than on the size of the finalised database.
- Define which variables from the data set you will require early and be clear why you require each variable for your analysis.
- Iveson TJ, Kerr RS, Saunders MP, Cassidy J, Hollander NH, Tabernero J, et al. 3 versus 6 months of adjuvant oxaliplatin-fluoropyrimidine combination therapy for colorectal cancer (SCOT): an international, randomised, phase 3, non-inferiority trial. The Lancet Oncology. 2018;19(4):562-78.