Dawn Niccum, Director, Quality Assurance, inSeptionGroup
For those who remember the days of rotary dial phones and dot matrix printers, the changes in technology have been incredible. We now hold in the palm of our hand, more powerful computing power than what put man on the moon.
Clinical drug development has seen similar advances and continues to accelerate. We are now talking about organizing disparate data available in real time at the click of a button. Clinical trial management has moved from the use of spreadsheets and simple listings to charts, graphs, and meaningful metrics.
The most critical piece of all these technology advances is having the right people and processes to harness their power. Advanced technology can be dwarfed by forgetting to bring the people along in the journey. People with years of experience can often be overwhelmed by new technologies. Robust change management needs to be part of the technology implementation. This includes reviewing and updating processes to leverage the technology.
In the early days of implementing Electronic Data Capture (EDC), many companies would give a brief training session and leave the sites, monitors, and data managers to determine how to use the technology.
The concept being that these highly experienced people would know how to best use these systems. Processes were either based on the use of paper case report forms or so diverse that it negated the quicker receipt of data. Clinical sites felt that the time entering data in EDC was significantly more than that of paper case report forms. As such, sites were requesting additional funds when a trial was planning to use EDC. EDC adoption was slow and user resistance of adoption was high.
Only when the users of the technology were brought along for the journey, the industry began to see efficiencies including faster data availability, decreased data cleaning, and shorter times to data base lock.
The next wave of technology adoption included separate systems for clinical trial management (CTM), randomization and drug distribution (Interactive Response Systems – IxRS), laboratory data, etc. Again, these technologies were developed primarily by information technology experts and senior level functional representatives. Only when the everyday user is given the opportunity to view and interact with the systems, the adoption goes from a slow to a rapid trajectory.
With the adoption of ICH E6(R2)–Integrated Addendum to ICH E6(R1): Guideline for good clinical practice, the expectation from regulators is that the use of data is optimized to demonstrate the risk and vendor management and also the overall management of the clinical trial. In the addendum section to 5.18.3, ICH states “The sponsor should develop a systematic, prioritized, risk-based approach to monitoring clinical trials.” This section goes on to describe activities that may be conducted using centralized monitoring. Both risk based monitoring technology and the accompanying complex statistical analysis are essential to conduct centralized monitoring activities.
Also, in ICH E6(R2), section 5, Quality Management, addresses using risk based approach to managing the overall quality of the clinical trial. Use of technologies and tools to help with risk identification has also seen a similar upswing as risk management is no longer just a best practice but required.
To avoid similar resistance to the implementation of these technologies as was seen with EDC, companies need to continue to change management activities. Don’t forget to bring people along for the journey.