Our Clinical Research 101 series takes an in-depth look at key steps and tips for navigating the clinical research process. The tenth installment in our Clinical Research 101 series is by Dr. Shirley Wong, the TAVR Research Project Manager at the BC Centre for Improved Cardiovascular Health (ICVHealth). The following is an overview of clinical research with medical devices, including what it is, why it is important and what it entails.
Dr. Wong manages international studies that investigate the application of The Vancouver, Multidisciplinary, Multimodality, but Minimalist (3M) Clinical Pathway with transcatheter aortic valve replacements (TAVRs).Within this procedure, selected patients are awake when they undergo a TAVR and are then safely discharged the following day. These studiesinvolve the use of a medical device, specifically, aortic valves.
A device is defined by the Food and Drugs Act as:
- “an instrument, apparatus, contrivance or other similar article…including a component, part or accessory of any of them, that is manufactured, sold or represented for use in diagnosing, treating, mitigating or preventing a disease, disorder or abnormal physical state, or any of their symptoms.”
In Canada, medical devices are classified into Class I, II, III, and IV based on a device’s level of invasiveness. Studies involving medical devices may require submitting an Investigational Testing Application (ITA) when the device is not yet licensed or is being tested for a new indication of use. Clinical trials using unapproved devices must label them as “for investigational use only”.
Unlike clinical trials for drugs, trials with medical devices are not classified by phased development (i.e., Phase I, II, III, and IV). Nonetheless, like any other clinical study involving human subjects, the sponsor is still responsible for:
- Protecting the rights, safety, and well-being of participants;
- Ensuring that the study is conducted with integrity and that participants’ best interests are always considered;
- Ensuring the scientific conduct of the study and the credibility of its results.
For more about sponsor responsibilities, read a previous Clinical Research 101 submission from Leslie Love, Senior Project Manager at CHÉOS.
When do I need an ITA?
An ITA is required when applying for authorization to initiate a clinical study to assess the safety and performance of a new medical device. It is only required for Class II, III, and IV devices, not less invasive Class I. The application is submitted to Health Canada’s Medical Device Bureau as per the guidelines on the Health Canada website. If approval is provided, a “No Objection Letter” is sent to the sponsor indicating Health Canada’s agreement on conducting the study.
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