Question 1

What is the Meaning of Platform Trial?

Accepted Answer

A Platform Trial is an innovative and highly efficient clinical trial design that uses a single, overarching master protocol and shared infrastructure to evaluate multiple interventions simultaneously or sequentially against a common control group. This design is characterized by its "perpetual" or open-ended nature, allowing new treatment arms to be seamlessly added and ineffective arms to be dropped based on interim data analysis without having to terminate and restart the entire trial. This model represents a shift from an intervention-focused question to a disease-focused question, seeking the best therapy for a specific condition.

Question 2

What is the Origin of Platform Trial?

Accepted Answer

The concept of platform trials evolved from earlier adaptive trial designs and gained significant prominence in the 21st century, particularly in therapeutic areas like oncology and infectious disease where multiple agents are rapidly developed. The term "platform" is metaphorical, referring to the stable, underlying infrastructure—the master protocol and shared operational resources—that supports the flexible, dynamic testing of multiple therapies. The urgent need for rapid answers during the COVID-19 pandemic further accelerated the global adoption and refinement of this methodology.

Question 3

What is the Mechanism of Platform Trial?

Accepted Answer

The operational mechanism relies on the master protocol, which standardizes elements like eligibility criteria, primary endpoints, and data collection procedures across all treatment arms. The trial employs a common control group, which reduces the total number of patients exposed to placebo or standard care, significantly enhancing ethical and resource efficiency. Statistical adaptations, such as response-adaptive randomization and pre-specified stopping rules for futility or success, are built into the protocol. This allows the trial to dynamically re-allocate patients to the most promising arms and quickly discontinue treatments that show minimal benefit, optimizing the learning process in real time.

Platform Trial

Meaning

Origin

Mechanism

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