Clinical Safety,Administration and Data Systems: How Should They be Integrated?

Abstract

Many pharmaceutical companies invest a great deal of effort in systems to manage clinical data, systems to oversee the planning and management of clinical trials, and systems to handle adverse event reporting, both clinical and spontaneous. This paper discusses various aspects related to the integration of these systems, both political and technical.

The first question to address is should these systems be integrated at all? It is likely that within even a small drug company, the responsibility for these systems lies within different departments. There may be a clinical data management group, a medical surveillance and reporting group, and another group of clinicians responsible for the overall development process. There is a benefit in linking these functional areas, through automated data feeds and consistency checks. The three systems, however, remain independent, and the three departments involved own and control their own data.

A critical aspect to the integration process involves the use of a centralized codelist and dictionary manager, accessed by the three systems but controlled at a single point. This ensures that all coded items are common (eg, product codes, indication codes, country codes) and also that matching dictionaries are used (eg, WHOART, COSTART, ICD-9). Thus, safety data in the clinical system can be easily matched to adverse event (AE) reports in the safety system.

There are many other areas of overlap between the three areas, relating to such matters as consistency of protocol design in the administrative system and case record form (CRF) design in the data management system. There are issues of data quality that are determined at afield and CRF level within the data system, that can be aggregated within the administrative system and used to derive an overall measure of the quality of a center, a study, and ultimately an entire submission. There are many issues relating to the storage of adverse events in both the clinical and safety systems, in terms of the timing of receipt of data, its existence in one system but not the other, and the consistency of data recorded in both systems.

This paper will focus on DLB Systems' experience within pharmaceutical companies involved in the implementation of the above systems, and in their approach and success to date with the integration issues.