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The topic is device clinical trials. This term refers to the use of medical products on/in humans, in order to gain useful knowledge about the product. Such knowledge might be required to enable the development of user instructions, better understanding of limitations, evidence of clinical usefulness, or elements of product design that require additional changes.
These trials are very expensive in outlay, personnel time and elapsed time. FDA regulations are designed to ensure that trials conducted in the US are performed with a number of safeguards, not only for the patient undergoing the trial, but for the sponsor of the trial, to ensure that sufficient thought has been given to protocol development, patient safety, definition of endpoints, data analysis, and data integrity .
This lecture will go over how the IDE regulations work, how they integrate with the design control requirements in 820.30, pre-market, and how post market clinical trials can be conducted with no conflict between trial data vs record-keeping and reporting requirements of commercial device establishments.
Why should you Attend: In spite of the long experience device companies have with clinical trials regulations (published 25 years ago), many companies have found this area an expensive trap. In fact, the only thing more expensive than a good clinical trial is a bad clinical trial. The probability of a successful trial is a function of the thought and experience that goes into a trial design. The thought, organization, compliance and analysis can be assisted by outside consultancies, such as CROs, but the experience has to be internal, a deep knowledge of the particular device, how it works, what its limitations are, what the company wants it to do, and the likelihood of its performing as desired.
There is an old engineering axiom, "if it works, it must be obsolete." For pivotal clinical trials, the product MUST WORK, and convincing development teams to settle down and define a trial-ready model is one of the most critical tasks in the whole product development cycle. Unrealistic estimation of the time required to describe and develop the trial-ready device has caused the downfall of some device start-ups. However forcing a pivotal trial of a poorly characterized device to satisfy an unrealistic timeline is a very expensive lottery ticket, with about the same probability of success as the cheap ones you buy at the gas station. Unfortunately, since FDASIA (2012) you will not be able to depend on approval of your investigational device exemption (IDE) to rescue you from a poorly-designed trial, since FDA is no longer legally able to reject a request for an IDE simply because they do not believe the trial will support a claim of safety and/or effectiveness in a subsequent marketing submission. Only proactive companies, requesting pre-submission discussions, will be informed of flaws in their design that make it unusable to show device safety and/or effectiveness. Also, once the product is approved or cleared, there may be post-marketing studies, some of which may be under IDE (new indication), and some of which may be marketing studies (no change in cleared/approved labeling studied) which are exempt from IDE requirement.
You will then be faced with questions like: "Do I label the product going to a marketing study "investigational"?, and "Does the IDE study have to report under 803 and 806, or is it still under IDE regulation for reporting adverse events, or both?"
Areas Covered in the Session: