---
title: The Missing Step Between Phase I and Phase II
description: Too often, new drugs fail during development due to poor study design and inadequate knowledge about the performance of a new drug.
---

[Blog - TD2 Precision Oncology ](https://blog.td2inc.com)

# [The Missing Step Between Phase I and Phase II](https://blog.td2inc.com/the-missing-step-between-phase-i-and-phase-ii)

 Written by [TD2 Admin](https://blog.td2inc.com/author/td2-admin) | January 28, 2019 at 5:16 PM

> Too often, new drugs fail during development due to poor study design and inadequate knowledge about the performance of a new drug. A large part of these mistakes take place between Phase I and Phase II. That’s why TD2 created the Dynamic Trial, an adaptive approach that adds exploratory cohorts for faster insights earlier in the development process.

**What’s the Dynamic Trial?**

The [DYNAMIC Trial](https://td2inc.com/the-dynamic-trial-is-it-the-right-option-for-you/) features an add-as-you-go model, where expansion cohorts evolve as new data emerges. It appends exploratory cohorts to the Phase I trial to test various scenarios and clarify emerging questions about the drug’s actual performance. Small patient cohorts can be explored to define the best go-forward strategy.

**What’s the Purpose?**

The information gained in a Dynamic Trial study negates the need for exploratory Phase II trials, saving time and money. As a result, researchers can achieve in one trial what traditional models achieve in as many as four separate trials.

**Is the Dynamic Trial for Me?**

If you lack confidence in your drug’s registration pathway and need more verification points before advancing to a definitive or pivotal Phase II—or you’re considering several trial designs at once—you might want to consider this unique, adaptive trial design before moving straight to Phase II.

**Is It FDA-Supported?**

As a form of adaptive design, the Dynamic Trial model is not just supported by the FDA—it’s recommended. Just a few months ago, for example, the agency released a guidance document that aims to modernize trials with this adaptive approach which TD2 has been performing for a decade.

[View full post](https://blog.td2inc.com/the-missing-step-between-phase-i-and-phase-ii)

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