Clinical researchers’ lived experiences with data quality monitoring in clinical trials: a qualitative study

Abstract

Background Fundamental to the success of clinical research that involves human participants is the quality of the data that is generated. To ensure data quality, clinical trials must comply with the Good Clinical Practice guideline which recommends data monitoring. To date, the guideline is broad, requires technology for enforcement, follows strict industry standards, mostly designed for drug-registration trials and based on informal consensus. It is also unknown what challenges clinical trials and researchers face in implementing data monitoring procedures. Thus, this study aimed to describe researcher experiences with data quality monitoring in clinical trials. Methods We conducted semi-structured telephone interviews following a guided-phenomenological approach. Participants were recruited from the Australian and New Zealand Clinical Trials Registry and were researchers affiliated with a listed clinical study. Each transcript was analysed with inductive thematic analysis before thematic categorisation of themes from all transcripts. Primary, secondary and subthemes were categorised according to the emerging relationships. Results Data saturation were reached after interviewing seven participants. Five primary themes, two secondary themes and 21 subthemes in relation to data quality monitoring emerged from the data. The five primary themes included: education and training, ways of working, working with technology, working with data, and working within regulatory requirements. The primary theme ‘education and training’ influenced the other four primary themes. While ‘working with technology’ influenced the ‘way of working’. All other themes had reciprocal relationships. There was no relationship reported between ‘working within regulatory requirements’ and ‘working with technology’. The researchers experienced challenges in meeting regulatory requirements, using technology and fostering working relationships for data quality monitoring. Conclusion Clinical trials implemented a variety of data quality monitoring procedures tailored to their situation and study context. Standardised frameworks that are accessible to all types of clinical trials are needed with an emphasis on education and training.

Clinical data management A Review of Current Practice in Australia

“…In a recent qualitative study, Australian clinical researchers expressed a lack of guidance, education, and training in relation to data management and monitoring. 5 This study suggested that clinical data managers in both academic and industry settings have received either on-the-job training or self-paced learning focusing on specific work procedures. This doesn't necessarily mean that GCP training was not conducted.…”

“…In Australia, it is known that large-scale clinical studies have tended to move towards electronic data capture (EDC) systems or have accumulated implementation expertise with IT systems more rapidly than smaller-scale clinical studies. 5 For small studies, it is more likely to see a continued presence of traditional paper-based data capture methods as a perceived effective strategy. As the same requirements are necessary in Australia regardless of the study design or clinical focus, small-scale clinical studies need to consider the additional costs that operating an EDC system may incur for staff training, maintenance, support, hardware, and security requirements.…”

“…On the other hand, academic studies are often smaller and more flexible to incremental change. 5 Academic-and non-profit-led clinical studies are known to fluctuate in their funding availability and are often driven by external influences.…”

Exploring the conduct and reporting of qualitative research in trials using mixed methods

“…Researchers conducting trials are required to meet ethical and scientific standards for conducting and reporting trials that include the collection of high quality data (204,205). To help ensure compliance with these guidelines, high quality data monitoring and adherence to trial procedures is recommended (204). Qualitative research can help to understand how trial processes such as data monitoring are enacted.…”

“…Qualitative research can help to understand how trial processes such as data monitoring are enacted. It can help to assess fidelity to trial processes and procedures and to identify and overcome obstacles to good practice (28,165,203,204).…”