Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices (ENG)
Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
Presenter: Sang Ho Park
Similar to previously covered guidelines, this guideline discusses the circumstances under which Real World Evidence (RWE) can be generated. Additionally, this guideline does not modify existing regulatory decision-making guidelines but rather explains Real World Data (RWD) that supports FDA decisions according to existing evidence standards.
Traditional clinical trials target a rather limited patient population and demonstrate effectiveness in controlled clinical trial settings, which may significantly differ from actual clinical environments. Therefore, utilizing RWD can potentially provide information about a larger patient population. However, data generated in real clinical settings often isn’t created for research purposes, so potential biases may exist. Thus, careful study design is necessary to mitigate these biases, and it’s important to prepare research protocols and analysis plans in advance.
If there’s a distinctive feature of this guideline compared to previously covered ones, it’s the detailed explanation of the Investigational Device Exemption (IDE). An IDE is required to conduct clinical trials using unapproved medical devices. For drugs, this corresponds to an Investigational New Drug (IND). Even when generating RWE using RWD, there are cases where an IDE is required. In what cases? An IDE is required when patient treatment changes based on whether data is being collected. In other words, if patients receive treatment according to routine medical practice regardless of data collection, an IDE isn’t necessary. However, if medical devices are prescribed to patients specifically to collect information about their effectiveness and safety, an IDE is required. While previous drug guidelines didn’t address IND, I was impressed by this guideline’s detailed explanation of IDE.
The following examples of RWD are explained. The following content is similar to what was covered in previous guidelines:
- Expanding device indications using registry data
- Postmarket surveillance studies
- Post-approval device monitoring
- Control groups in clinical studies
- Supplementary data for safety evaluations
- Developing objective performance criteria
Original material : Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
Presentation material : PseudoLab Presentation : Sang Ho Park
English translation by Claude 3.5 Sonnet (New)