Implementing ICH E6 (R3) In A Risk Averse Culture: 4 Tips To Abate Free Floating Anxiety In Your Organization

By Christina Dinger, Senior Director of Product, ThoughtSphere

While the concept of achieving "perfect data" is widely acknowledged as unattainable, seasoned Clinical Trial Managers and Data Operations Managers have been ingrained with the institutionalized goal of striving for and expecting this ideal.

Although regulatory bodies such as ICH E6/E8, the FDA, and EMA have emphasized the need for a shift, asserting that "Clinical trial processes and risk mitigation strategies should be proportionate to the importance of the data being collected and the risks to trial participant safety and data reliability" (ICH E6(R3), Draft, 19 May 2023), actually moving away from the perfection paradigm has presented a formidable challenge.

Transitioning from the ideal of perfect data to delivering fit-for-purpose data introduces ambiguity and the fear of overlooking something crucial. The industry no longer approaches all clinical data with equal scrutiny and inclusivity; instead, it has become selective in prioritizing data and focusing our review efforts. This departure not only contradicts past practices in clinical research but also challenges cultural values of equity, inclusivity, and equality across humanity. Unsurprisingly, the shift to Risk-Based Quality Management (RBQM) is met with resistance.

To embrace the RBQM approach and adopt a more selective, risk-tolerant review strategy for clinical trials, teams must ensure confidence in the correctness of the prioritized data. This necessitates organizations to adopt an agile, multi-faceted, and continuous risk and issue management approach aligned with the Statistical Analysis Plan.

Access the full article to get several pointers on how to facilitate this transition.