Early feasibility studies (EFS) can be an important tool in the development of a novel medical device or an existing medical device with a new intended use. EFS is an FDA pathway to gain initial clinical experience with a device in order to move the device design forward; for example, when there are no established nonclinical testing methods to address the remaining questions about the viability of the device design or the target patient population needs to be refined. Because of this, testing may not yet be complete for an EFS device, and the risks and requirements for the EFS are different than for a pivotal study. A CRO that specializes in early feasibility studies can help navigate these idiosyncrasies and help get your device to a decision-point faster.
Top 6 Special Considerations for EFS:
Pre-submission meetings are often helpful to create the best IDE submission possible, with a higher chance of FDA approval. For an EFS IDE, it is strongly encouraged to contact a representative from the FDA EFS program to discuss your submission and the justifications as to why it will qualify as an EFS (e.g., it is a novel device type where nonclinical testing does not provide the information needed to finalize the device design). The next step will be to submit a pre-submission packet requesting a Q-sub meeting. Click here to review the FDA guidance for the Q-submission program. The content included in the packet should provide context to the FDA reviewers surrounding the medical condition and the device, to provide rationale for conducting an EFS, and to solicit feedback on the device evaluation strategy, testing plan, and the clinical investigation plan. Once you have a clear picture of FDA’s expectations, an original EFS IDE application can be submitted with the best chance for approval.
The proposed device evaluation strategy is the cornerstone of an EFS IDE submission. Early feasibility studies may be conducted before the device design is locked and before all bench testing can be completed. Therefore, to conduct initial use of the device in humans, all possible risks must be identified and mitigation strategies considered to reduce risks as far as possible. The device evaluation strategy is created in the form of a comprehensive table that lists relevant aspects of the device, and for each aspect: purpose, potential failure modes, known information, non-clinical testing that may inform the failure mode, and risk mitigation strategies that will be incorporated into the clinical study. For more information, click here to review the FDA guidance on EFS IDEs.
It is important to utilize oversight of an IRB that has experience with early feasibility studies and the somewhat different associated patient risks. The informed consent document and the IRB submission paperwork should emphasize that the device and its use is not as mature as with other studies. Potential benefits are less certain, and potential risks are less well understood or predictable. Discuss the risks and subject protection measures that will be implemented to address them. It would also be wise to plan for additional reporting requirements (at least annually).
Study success depends on a Principal Investigator who is well-suited for the unique requirements of an EFS. He or she must see the right type of patients and be willing to follow the strict criteria for patient selection. The PI must have sufficient time available to spend with the patients, explaining the study and associated risks as well as communicating with them closely throughout the treatment and follow-up. The PI must have time to work with the sponsor to refine the techniques for using the device, and be willing to provide suggestions for improving the device design, bench testing acceptance criteria, future clinical study inclusion/exclusion criteria, etc.
EFS participants must be willing partners in research who understand the nature of these types of studies and the relative uncertainty regarding risks and potential benefits. They must be willing to communicate closely with the investigators or even with the study sponsor to provide a thorough understanding of their experience with the device. The participants should share their priorities regarding risk tolerance and benefits, outcome measures, study design elements, and burdens of participation. Patients’ experiences can also help to clarify the appropriate patient population to target in future studies.
If you’ll be engaging a CRO to conduct the study, it is of course important to choose one that is experienced with successful early feasibility studies. Perhaps even more importantly, the CRO must be well-experienced with the device development process in order to understand the device evaluation strategy, potential failure modes, and risks that are present due to incomplete nonclinical testing. The CRO must be engaged and communicative to quickly relay information that may help refine the device design, target patient population, or techniques for using the device. Finally, the CRO must have the flexibility to incorporate changes to the device or study design quickly.
Our team of clinical trial experts can help you navigate the early feasibility studies process to maximize the chance of IDE approval and a successful EFS, resulting in shortened timelines to go/no-go decisions, device design lock, instructions for use, and well-designed subsequent pivotal studies. Contact us today 855.463.1633 | 765.463.1633 | askmed@ medinstitute.com | medinstitute.com
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