Improving Data Quality in Disease Registries and Clinical Trials: A Case Study from the ENSAT-CANCER Project

Glockner, S., Arlt, W., Bancos, I., Stell, A. and Sinnott, R.O.

The Internet-era has given rise to a global increase in information availability and coupled with technologies that allow data to be produced at an exponential rate; a maelstrom of data, information and potential for new knowledge now exists. This has huge implications for the clinical and biomedical sciences in the post-genomic era where whole genome and exome sequencing technologies are increasingly prevalent and producing copious amounts of sensitive data at an unprecedented rate. This deluge of information is both a challenge to researchers and to clinical care providers as well as an opportunity. To tackle this, many biomedical research communities focus on subsets of information through establishing targeted disease registries consisting of clinical (phenotypic) information on patient cohorts. These registries are often used for targeted recruitment to clinical trials and studies. One such example of this is the European Network for the Study of Adrenal Tumours (ENSAT – www.ensat.org), which has established an extensive range of deeply phenotyped information on patient cohorts with different adrenal tumour subtypes. This resource is used to support a portfolio of clinical trials covering international phase 1 to phase 4 studies. One of these is the EURINE-ACT study. In this paper we focus specifically on the data quality issues that have arisen in ENSAT and the demands of studies such as EURINE-ACT. We identify future steps that are to be taken to improve the data quality including automated data quality assessment scores and user community feedback assessment.

Cite as: Glockner, S., Arlt, W., Bancos, I., Stell, A. and Sinnott, R.O. (2015). Improving Data Quality in Disease Registries and Clinical Trials: A Case Study from the ENSAT-CANCER Project. In Proc. 8th Australasian Workshop on Health Informatics and Knowledge Management (HIKM 2015) Sydney, Australia. CRPIT, 164. Maeder, A. and Warren, J. Eds., ACS. 25-32

(from crpit.com) (local if available)