Approval Is the
Only Milestone
That Matters
And it hinges on a single question:
“Why should we believe you?”And it hinges on a single question:
“Why should we believe you?”Most sponsors aren't prepared to answer this question because it's fundamentally different than what operational strategies plan for.
The plan looks reasonable:
The gap between the original question and this all too common plan is big enough to swallow a Phase III registrational trial.
We all commit to meeting the expectations of ICH E6. The major regulators (BIMO, Annex IV, Clinical trials for medicines: Good clinical practice inspections, J-GCP, GUI-0100, NMPA 2020 GCP) tell us how they are going to hold us accountable, and are clear that they prioritize participant rights, safety, welfare, and data reliability above all else. The expectations are fixed, published, and consistent regardless of indication, modality, or agency.
The methodology should be obvious. Design the trial oversight to produce what we know the agencies are going to ask for. No guessing. No re-invention of the wheel. Our CROs and vendors get clear expectations. Our internal teams get a standard way of working and relief from ambiguity. Every choice engineered to answer the essential question. No wasted words, no wasted effort.
Instead, we run trials the best we can with the people we have. When we're all done we pay a mock inspector to tell us what we've done wrong after it's too late to do it right. But hope is not a plan and none of this makes trial execution easier, more efficient, or less burdensome.
Only about ten percent of clinical trial operational teams ever come into contact with the essential question. The people equipped to change course are rare and rarely brought to small development-stage companies. But the risks that come with not having satisfactory answers are real, and they're priced in months of delays and millions in lost revenue.
Compliance used to be an Excel tracker. Now ICH E6 requires a demonstration of intentionality, not a checklist.
Ex-agency experience is rightfully expensive and has traditionally been aligned with post-mortems rather than prevention.
Industry-specific methods, tools, and platforms require deep domain expertise, inspection experience, and the resources and time to build them from scratch.
That's all changed.