Master Protocol Trial Design for Efficient and Rational Evaluation of Novel Therapeutic Oncology Devices

Area of Science:

• Oncology
• Medical Devices
• Clinical Trials

Background:

• Randomized clinical trials are the gold standard for evaluating cancer therapeutics, but Class II devices often lack rigorous pre-approval evaluation.
• Therapeutic oncology devices, particularly radiation oncology devices (RODs), face unique challenges in clinical testing, including patient heterogeneity, funding limitations, and operator dependence.

Purpose of the Study:

• To review master protocol designs in medical oncology and their application to therapeutic oncology devices, specifically RODs.
• To propose master protocols as a solution to optimize the efficiency of clinical trials for RODs.

Main Methods:

• Review of master protocol designs in medical oncology.
• Application of master protocols to therapeutic oncology devices, with examples from radiation oncology.
• Outline of a phase I/II master protocol trial for stereotactic magnetic resonance imaging-guided adaptive radiotherapy as a practical example.

Main Results:

• Master protocols can enhance regulatory, financial, administrative, quality assurance, and statistical efficiency for ROD trials.
• The proposed master protocol design can be adapted for other devices and encompass multiple substudies.
• The outlined trial represents a novel approach as the first master protocol trial to test a ROD.

Conclusions:

• Master protocols provide a framework for more efficient clinical trials of therapeutic oncology devices, including RODs.
• Efficient clinical trial designs are crucial for thorough evaluation of RODs in resource-limited settings.
• This approach facilitates the practical and rapid identification of significant advancements in the field.