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Current issues in dose-finding designs: A response to the US Food and Drug Adminstration's Oncology Center of
Peter F Thall1, Elizabeth Garrett-Mayer2, Nolan A Wages3
1Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Abstract:
With the advent of targeted agents and immunological therapies, the medical research community has become increasingly aware that conventional methods for determining the best dose or schedule of a new agent are inadequate. It has been well established that conventional phase I designs cannot reliably identify safe and effective doses. This problem applies, generally, for cytotoxic agents, radiation therapy, targeted agents, and immunotherapies. To address this, the US Food and Drug Administration's Oncology Center of Excellence initiated Project Optimus, with the goal "to reform the dose optimization and dose selection paradigm in oncology drug development." As a response to Project Optimus, the articles in this special issue of Clinical Trials review recent advances in methods for choosing the dose or schedule of a new agent with an overall objective of informing clinical trialists of these innovative designs. This introductory article briefly reviews problems with conventional methods, the regulatory changes that encourage better dose optimization designs, and provides brief summaries of the articles that follow in this special issue.
Insights
Conventional methods for selecting cancer drug doses are inadequate. Project Optimus and innovative clinical trial designs aim to improve dose optimization and selection for targeted agents and immunotherapies.
Area of Science:
- Oncology
- Clinical Trials
- Drug Development
Background:
- Conventional phase I clinical trial designs are insufficient for identifying optimal doses of new cancer therapies.
- This inadequacy affects cytotoxic agents, radiation therapy, targeted agents, and immunotherapies.
- The US Food and Drug Administration's Oncology Center of Excellence launched Project Optimus to reform dose optimization and selection in oncology drug development.
Discussion:
- Innovative clinical trial designs are emerging to address the limitations of traditional methods.
- These advancements aim to ensure safer and more effective dosing strategies.
- The special issue of *Clinical Trials* highlights these novel approaches for clinical trialists.
Key Insights:
- Project Optimus signifies a regulatory shift towards prioritizing robust dose optimization.
- New methodologies are crucial for advancing the efficacy of targeted and immunotherapies.
- Understanding and implementing innovative designs is key for future oncology trials.
Outlook:
- Continued development and adoption of advanced dose-finding methodologies are expected.
- Improved dose selection will enhance patient outcomes in cancer treatment.
- Regulatory support for Project Optimus will likely drive further innovation in clinical trial design.
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