Assessing the feasibility of GSK’s clinical genetic data re-use for drug target identification and validation: A respiratory case study

Clinical trial data represent a rich data source, with considerable value to address scientific questions broader than the original purposes of the clinical trials. This is particularly true when longitudinal, clinical and biomarker data are linked to genome-wide genetic data. We assessed the scope, value and limitations of re-using data from respiratory clinical studies to identify new targets, support existing ones, and forge new academic-pharma or pharma-pharma partnerships. An extensive data collationeffort and review of informed consent language identified 32 respiratory clinical studies for which genome-wide genotype data has been generated for the purpose of pharmacogeneticsresearch, and where patients had provided consent for broader research including drug target identification and validation. These were 21 studies for COPD and 11 for asthma, of which 11,378 and 5,492 patients have genetic data available, respectively. Additional clinical study information was collatedon disease-related endpoints (primary, secondary, exploratory, safety), biomarkers, ethnicity, longitudinal data and inclusion/exclusion criteria. We will summarise data on a rich set of relevant respiratory diseasesubtypes, including COPD exacerbations, pneumonia, lower respiratory infections, and longitudinal change in lung function. This deeply phenotyped and genotyped patient dataset will be critical in designing studies to address respiratory drug target identification and validation questions and instrumental in forging collaborations with academic and other pharma partners to further respiratory diseaseunderstanding.