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Blog
The Role of FDA Initiatives in Early-Phase Oncology Trials
David Cameron, MPH, Senior Director and Global Head, Novel Trial Design, IQVIA
Mar 06, 2025
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  • The Role of FDA Initiatives in Early-Phase Oncology Trials

The FDA's Project FrontRunner is a transformative initiative aimed at accelerating the development of oncology therapies by shifting the focus to earlier lines of treatment. This blog post delves into the broader context of FDA initiatives, such as Project Optimus and Project FrontRunner, and their impact on early-phase oncology trials.

How can FDA Initiatives be incorporated into Early-Phase Trial Design?

Emerging FDA initiatives, such as Project Optimus for dose optimization guidance and Project FrontRunner for guidance on seeking earlier approvals for oncology therapies, play a crucial role in shaping early clinical trial strategies. These initiatives encourage a more structured approach to determining the right dose and selecting the best patient population to evaluate earlier in the treatment continuum.

A common starting point in early-phase oncology development is dose escalation. While the traditional 3+3 design is still seen, more sponsors are turning to Bayesian Optimal Interval (BOIN) or Bayesian Logistic Regression Model (BLRM) methodologies to find a recommended Phase II dose more efficiently. After identifying this "working dose," the next step is often to conduct dose expansion cohorts. These cohorts help confirm efficacy signals in specific tumor types and refine the therapy's risk-benefit profile.

The Broader Context: FDA's Oncology Center of Excellence

Project FrontRunner is one of over 30 initiatives spearheaded by the FDA's Oncology Center of Excellence (OCE). These programs share a unified goal: to advance patient-centered regulatory decision-making through innovation and collaboration. Highlights of these initiatives include:

  • Diversity in Clinical Trials: Encouraging inclusive enrollment to ensure therapies are effective across diverse populations.
  • Dose Optimization: Refining dosing strategies to balance efficacy and safety.
  • Real-World Evidence Integration: Leveraging data from real-world settings to contextualize trial results and support regulatory submissions

Key Elements of Project FrontRunner

Project FrontRunner challenges the traditional drug development model, which historically introduced new oncology therapies in late-stage treatment settings. Instead, this initiative shifts the focus to earlier lines of therapy, particularly in advanced or metastatic diseases. The goal is to provide patients with earlier access to innovative treatments, generate robust clinical evidence to support benefit-risk assessments, and promote collaborative innovation by encouraging sponsors to work closely with regulators and stakeholders.

How to Exercise Advanced Trial Designs with Project FrontRunner

Adaptive designs and master protocols are becoming more important, allowing studies to evolve as data comes in. These methods speed up decision-making, make it easier to enroll the right patients, and ultimately generate stronger evidence in less time. By integrating these evolving strategies—dose escalation, optimization, and expansion—sponsors can position themselves to seamlessly transition into earlier-line trials aligned with Project FrontRunner principles.

What does the future look like?

Project FrontRunner holds immense promise, but it comes with challenges. Achieving regulatory alignment across international agencies, funding large-scale trials based on early-phase data, and finding consenting patients for novel therapies in the first-line setting are significant hurdles. However, the initiative's alignment with innovative trial designs and regulatory priorities opens the door to faster, more effective cancer treatments. As more data emerges and successful case studies are published, the adoption of Project FrontRunner is likely to increase, cementing its role in the future of oncology.

To learn more, read the related white paper, Transforming Cancer Treatment: The Impact of FDA Project FrontRunner on Oncology Drug Development where IQVIA experts discuss best practices for designing robust, randomize trials and delve into understanding the benefits of early access to investigational cancer therapies and how to successfully navigate the evolving regulatory landscape and more.

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