Planning a Phase I Trial? Do Not Fear Regulatory Feedback – Learn from It

If you are never challenged, you are probably not doing anything new

For many early-stage biotech and pharma teams, regulatory feedback feels like a threat. You have built your study design, modelled your dosing regimen and you are finally ready to move. But then questions start rolling in from the agency with doubts, stipulating conditions which might cause delays. You feel like you are back to square one.

But here is the reality: regulatory pushback is not failure. It is friction that sharpens your thinking. In fact, if your design never triggers a single hard question, chances are you are not doing anything very innovative.

“Pushback means they are paying attention. And if you have done the work, that is exactly what you want.”

Regulators are not the adversary – your timeline is

It is easy to see regulators as gatekeepers. Bottomline: the health authorities want the same thing you do. A study that is safe, smart and built to generate high-quality data.

The challenge is that biotech and pharma teams often treat feedback as a block, when really it is just a signal to clarify your rationale, revisit your data and fill the gap in your story. And yes, it takes effort. But if you put in that work before submission, you do not just get approvals – you get confidence in your design.

“Regulatory hurdles are not necessarily roadblocks – they are checkpoints that keep your trials on the right path.”

Know when to comply. Know when to push back

Not every design will be textbook or fit neatly into a guidance document that outlines their expectations, recommendations and accepted practices for conducting clinical trials or submitting data. Especially if you are working with:

• Adaptive designs
• Complex multi-stage trials
• Special populations

We have helped sponsors defend all of the above. And we have seen what works.

The key? Do not limit yourself to the limitations of the regulatory playbook. Show that you understand the spirit of it and how your plan aligns with that. And if you believe in your rationale, stand by it professionally, calmly and with the data to back it up. Because smart regulators respect well-prepared confidence.

Regulatory strategy is a design discipline

This is often overlooked: your regulatory positioning is not just about paperwork, it is part of your trial design. And if you wait until submission to think it through, you are too late.

At SGS, we build regulatory logic into the protocol from the start:

• What will this design trigger, question-wise?
• Is the flexibility clearly worded?
• Have we anticipated requests for justification?
• Do the IB, IMPD and protocol tell one clear story?

This is where internal alignment and early strategic input make all the difference.

Final thought

The best early-phase teams don’t try to avoid feedback. They plan for it, learn from it and use it to strengthen their study.

If you are about to submit and worried about what regulators might say, ask yourself: “Have I made it easy for them to understand what we are doing and why it matters?” If not, you are not ready. But the good news? With the right support, you can be.

Want help building a protocol that stands up to regulatory scrutiny?

Talk to one of our early-phase consultants like Thomas Lodeweyckx – or start with our 25-question self-assessment tool.