Unifying Drug Safety and Clinical Databases

Abstract

Clinical and drugs safety organisations run their operation independently and use separate databases designed to comply with different data standards. This separation is neither efficient nor effective since investigators need to report serious adverse events both to the clinical and drug safety departments, causing the respective databases to contain partially overlapping data sets containing common elements that need to be reconciled. Electronic data capture provides the opportunity to avoid duplicate storage and obviate reconciliation. It also introduces the risk of non-compliance due to late submission of unexpected serious adverse reactions to competent authorities. This raises the potential for a clinical department to receive a case that the drug safety department is unaware of. However, the most significant inefficiency probably lies in the preparation of aggregate reports and regulatory documents that need to be prepared using data originating from both databases. In a resource-constrained world, unnecessary activities and associated costs are unwelcome, particularly when they are avoidable. The Clinical Data Interchange Consortium (CDISC) has set the standards for clinical trial data, while the International Conference of Harmonization (ICH) dictates drug safety ones. CDISC is expanding its Clinical Data Acquisition Standards Harmonisation (CDASH) model to capture adverse event data associated with ICH E2B. All common data items have two labels that have been mapped. This exercise is showing that there is no scientific justification for data segregation. The differences between these two standards can be attributed to conventions or arise from new technology that renders unnecessary the keying in of certain context information (dates, times and recorder ID). Once this mapping is completed then a common data acquisition process will become feasible. This is the prerequisite to ultimately unifying the two databases and to implementing more efficient processes. The Authors also propose a new workflow to provide safety with the array of benefits that technology and process harmonisation offers and ultimately unifying the clinical drug safety processes.

Drug-drug interactions with direct oral anticoagulants associated with adverse events in the real world: A systematic review

“…Publicizing existing internal data and/or funding of prospective studies to investigate how DOAC-specific laboratory tests correlate to clinical adverse events would provide useful clinical guidance. As such collaboration between these agencies and academia is called upon and can promote efficient and expansive research toward drug-drug interactions [ 76 , 77 ].…”

Electronic case report forms and electronic data capture within clinical trials and pharmacoepidemiology

“…In the UK, it has been suggested that development of these technologies suffers from the lack of a clear national direction towards unifying clinical and medical data, with no common format for all data systems. Not only would EDC benefit clinical research, but pharmacovigilance and drug safety regulation could also be improved .…”

The Future of Pharmacovigilance: Proposals for More Efficient and Effective Systems-Based Approaches

“…Once EDC systems are implemented, separate subdatabases can be retained to meet independent reporting requirements. However, a single aggregate database jointly shared by the clinical and drug safety departments is essential to advancing pharmacovigilance [12]. In practice, the idea is that once keyed in through EDC, all the safety information that is currently separately directed and stored in the clinical and safety database is stored in one single repository.…”