RECOVER is a multi-centre, real world non-interventional study which will take part in seven paediatric and adult sites across Ireland and the UK over a three-year period in conjunction with the CF Registry of Ireland (CFRI) and the UK CF registry. RECOVER will examine in detail the impact of the new triple combination CFTR modulator compound, Kaftrio®, on the lives and health of people with CF. In the UK, this study is classified as a low risk non-interventional clinical trial. People with CF will be independently determined by their CF consultant to be suitable for treatment with Kaftrio® in compliance with the official marketing authorization and summary of product characteristics. It is important to note that the decision to include participants in the study is independent of decision to prescribe Kaftrio®. RECOVER will be an important study for the CF community as it will gather together a wide array of both routine health data and less commonly used endpoints such as lung clearance index (LCI), Chest CT imaging, abdominal symptoms and inflammation, as well as medication adherence which promise unique insights into the real-world effect of Kaftrio®.
The design of RECOVER is specifically aimed at maximizing the research benefit (and ultimately the benefit to people with CF) from this cohort of children, adolescents and adults with CF. Our aim with this study is to collect as comprehensive as possible an array of biological samples and clinical data from this cohort, and to follow them longitudinally. After the end of RECOVER, we envisage an ongoing surveillance study involving this group, in collaboration with our registry partners so that we can continue to learn about the longer-term impacts of these treatments.
In addition, the sample storage plan associated with RECOVER will allow us to work with collaborators to collect, aliquot, and store biological samples that will magnify the benefit of the study in light of the fact that these samples will be linked to a well phenotyped cohort with a wide array of useful clinical outcome measures.
Real world studies such as RECOVER are of great importance to both regulators and bodies funding the provision of expensive medications such as Kaftrio®. These studies allow us to obtain a detailed understanding of the impact the introduction of these medicines to the clinical environment will have and ensure that medium to long term clinical outcomes are in line with trial data.
For more information about RECOVER please contact us at info@RECOVERCF.ie