How does an Early Feasibility Study differ from a Pivotal Study?

Clinical Trials

An Early Feasibility Study (EFS) is performed early in the device development process to evaluate the device functionality and preliminary clinical safety when non-clinical testing is unable to provide this information. Insights obtained from an EFS may be crucial in the device development process as the device design is still provisional and subject to modifications. An EFS in the U.S. is required to follow the same regulations as pivotal studies (21CFR812); however, success depends on the proper mindset from the sponsor and investigators due to the unique objectives. The FDA guidance for Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies outlines the EFS regulatory pathway, and we have previously discussed the ways sponsors should approach an EFS in order to be successful.

There are significant differences in the logistics of an EFS versus a pivotal study, and knowing how to conduct one does not guarantee success with the other. Below are some of the differences between an EFS and pivotal study.

• An Early Feasibility study is appropriate only when additional non-clinical testing is unable to provide the necessary information to advance the device development process; whereas, pivotal studies are performed with a final device design.
• An EFS will be designed to include a small number of patients, usually 10 or less, with comprehensive collection of information about device use and performance. In contrast, pivotal studies are designed to assess the safety and effectiveness of a device for a specified intended use, and typically include enough patients to support hypothesis testing.
• An EFS would include data collection of open-ended questions to gather as much information as possible to aid the device development process, whereas in pivotal studies the data collected is specific to well-defined measures of device safety and effectiveness for market approval.
• An EFS requires more intense monitoring due to the complex nature of the study when compared to a pivotal study; so, risk-based monitoring as is used for pivotal studies may not be the best monitoring strategy for an EFS.
• An EFS requires an FDA IDE pre-submission meeting to avoid unnecessary delays. FDA will determine whether the proposed clinical investigation (including preliminary non-clinical testing) can be considered as an EFS. Although an FDA pre-submission meeting can be helpful for a pivotal study, it is not always necessary.
• FDA IDE approval for an EFS may be based on somewhat reduced nonclinical data than would be expected for a pivotal study. However, additional risk analyses and mitigation strategies are necessary to offset any such reduction.

Unlike a pivotal study, an EFS has a broader purpose. Data obtained from an EFS facilitates the device development process, by helping to:

• Identify appropriate changes to the device or its use;
• Optimize techniques of product use;
• Refine the intended use population;
• Improve nonclinical test acceptance criteria or testing procedures; and
• Guide the design of subsequent clinical studies.

Contact our Clinical Research team for more information about designing EFS, navigating the EFS pathway with FDA, and conducting a study that allows feedback to flow amongst the stakeholders so your novel device may be clinically tested and data obtained in the most efficient way.

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