Why regulators are turning the screw on adherence in clinical trials
ICH E6(R3) sharpens the focus on critical-to-quality. Stronger adherence controls are a way sponsors meet it.
The fact that a global authority such as the ICH has adopted this new direction is clearly significant. Guideline changes form part of a lengthy and highly involved discussion and decision-making process; they are driven by an ambition to exploit opportunities for improvement or address areas of weakness, or both. If this process results in change, then it is because regulatory authorities and pharmaceutical industry bodies deem the status quo to be lacking.
In this context, adherence becomes a more pressing issue for sponsors and trial coordinators. Its inclusion within the sphere of critical-to-quality points to shortcomings in this area in the pre-ICH E6(R3) era and the need to update approaches to align with a new world order. In terms of compliance, the impetus therefore is to enhance quality controls around adherence to support trial coordinators in reducing dropouts, improving patient retention, and providing the ability to enhanced the clarity of data. All of which contributes to improved study power and the likelihood of a trial achieving its stated aims.
ICH is not the only authority to underline adherence as a core determinant of quality in clinical trials. In its Guidance for Best Practices for Clinical Trials issued in September 2024, the World Health Organization also calls for better-designed and better-implemented trials.[1] In addition, regulators such as the US Food & Drug Administration (US FDA) and European Medicines Agency (EMA) have implicitly pointed to the importance of evidencing adherence as trials evolve towards a more decentralised, accelerated and patient-centric future.
This collective momentum, driven predominantly by the introduction of the revised ICH E6 guideline, speaks to a growing urgency among regulators that is already flowing through to sponsors and clinical teams at ground level. The message is clear: there is room for improvement when it comes to existing trial practices. Moreover, the regulatory framework is now in place to support changes that will bring more efficiency, more accountability, and, ultimately, more quality.
Reflecting on this reality provides valuable perspective for the clinical trials sector today, underlining both the presence of an adherence gap and the regulatory emphasis on closing it. For sponsors and coordinators, it brings clarity to the importance of pursuing compliance strategies with a view to enhancing quality and limiting risk.
At the same time, however, it introduces a new set of challenges around implementation and the practicalities of instituting the changes necessary for alignment with ICH E6. Put simply, having acknowledged questions around the ‘why’ and ‘when’ of improving adherence and retention, the next crucial part of the puzzle must be solved: How?
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