Clinical Trial Strategy / Study Design
We begin the design of your medical device clinical trial with the formulation of appropriate study endpoints. Whether you need to collect data to support an FDA pre-market submission, a scientific publication, or drive physician adoption and market acceptance, these endpoints will support the content of your study and help you to determine the appropriate number of patients and study sites, study duration and length of follow-up.
Clinical studies can also include clinical evaluations of certain design modifications or changes to intended uses for legally marketed devices.
Additionally, the appropriate clinical trial strategy is dependent on where you plan to commercialize your medical device. European medical device requirements for clinical data can differ significantly from U.S. FDA requirements, so it is important to consider all these factors early in the development of your medical device clinical trial.
U.S. Clinical Data Requirements for Medical Devices
Clinical development of a new medical device is normally conducted in two phases; pilot and pivotal studies. In the pilot phase, the goal is to establish medical device safety and to assist in design of the pivotal trial. Medical device pilot or feasibility studies are generally limited to less than 100 patients at one or two sites. After establishing that the medical device is safe in this pilot group of patients, the pivotal trial is conducted to generate data to demonstrate that the medical device is safe and effective, for a defined intended use, within a certain patient population.
To market a class III high-risk (and some class II) medical device in the United States, you will need to demonstrate that the device is reasonably safe and effective. Generally, high-risk, class III medical devices that pose a significant risk of illness or injury will require a premarket approval or PMA submission, which will include clinical data to support medical device claims.
More and more, the FDA is requiring clinical data to support intended use statements and marketing claims for some class II medical devices that require a 510(k) premarket notification submission, rather than a PMA. In either case, if the FDA determines that your device is not exempt, you will need to apply for and receive an IDE (Investigational Device Exemption) before beginning any clinical studies.
For first-in-class medical devices, where there is limited data regarding short or long-term outcomes, the FDA pivotal trial would be a prospective, randomized controlled study, adequately powered and involving hundreds of patients at multiple study centers.
European Clinical Data Requirements for Medical Devices
In general, to support the European CE marking requirement, you must demonstrate that your medical device is safe, that it performs as intended, and that the level of risk is acceptable when weighed against its medical benefits. Within the European Medical Device Directives, the term “clinical data” encompasses everything from bench testing to clinical trials in human subjects. While some medical devices do require the conduct of a specifically designed clinical investigation, it is often possible, for low- to medium-risk devices (Class I, IIa, and IIb), to prepare a compilation of relevant scientific literature to support the device’s intended use and the techniques employed.
To market a device in the EU, you must demonstrate that the device is safe and that it performs in a manner consistent with the intended use.
Working with your team, we will help you design a clinical study to meet your needs and identify the best data measurements to support your product claims. Our experienced clinical services professionals will advise you on how to best measure the effectiveness of your product, in the most clinically meaningful and cost-effective way possible.