Considerations for Planning and Conducting Pre-clinical HF Validation Studies
TimeFriday, April 1612:30pm - 12:50pm EDT
LocationMedical and Drug Delivery Devices
DescriptionHuman Factors (HF) studies assess the safety and effectiveness of medical device and combination product user interfaces. HF validation studies are typically conducted through actual or simulated use testing prior to a product being released onto the market and used by real-world users. Simulated use testing for regulatory submission typically aims to represent ‘real-world’ settings such as clinics, hospitals, or patient homes. It’s often recommended to conduct HF validation studies with final finished products prior to major clinical studies to help ensure safe use by clinical study staff and patients in controlled clinical study settings. Depending on the timing of the product lifecycle, it may also be beneficial for a Sponsor to conduct clinical testing before the user interface design has been finalized. In this case, Sponsors are recommended to assess the product user interface that will specifically be used in a clinical study through a ‘Pre-clinical’ HF validation study. Although Pre-clinical HF validation studies may share similarities to typical HF Validation studies, the objectives of Pre-clinical validation studies are quite different, and because of this, there are nuances to be aware of when planning and performing Pre-clinical validation studies. Pre-clinical validation studies should be distinctly designed such that the users, uses, and use environments of the clinical studies are accurately reflected. For example:
- It’s possible that patients in a clinical study may have less experience with specific types of products and medications than end users of the actual final finished product. Additionally, clinical study staff (i.e., clinical study nurses) may not have a specialized expertise with a specific type of product that may be used in a clinical study. Depending on the product, it may be beneficial for Pre-clinical validation study participants to have a lack of experience with similar products, as this may be considered a conservative, and meaningful approach.
- The context of using the product should be clearly defined by the study moderator. How a product is used in a clinical study is often significantly different than in a real-life use scenario. Therefore, participants need to understand the clinical study setting so their responsibilities are understood and represented.
- Sponsors should be aware that the product use-related risk analysis may be adjusted to match the needs of the clinical trial. Although the risks of using the product during a clinical trial may be similar to that of the final finished product, it’s likely that product risk mitigations may contrast, as the user interface will likely have differences. Due to this, the user interface will be assessed in a very particular way. Additionally, patients may not independently use a product, and will often be monitored by clinical study staff, which often reduces a patient’s responsibilities while the product is used for treatment. Likewise, the role of the clinical trial staff may differ during the clinical trial in comparison to a typical clinical environment. This could be related to interactions and divisions of responsibilities between them and other clinical study staff members, as well as being expected to complete tasks that other users may typically complete for them when they are operating in a hospital environment or using unfamiliar methodology.
- The use environment in the clinical trial will be vastly different than a real-world use environment. The clinical environment will be specifically dedicated to using the product at-hand.
When analyzing the results of the Pre-clinical validation study, Sponsors should act by further reducing the risks related to using the clinical study user interface. Since the clinical study user interface may greatly vary from the final finished product interface, Sponsors should understand that interface re-design will specifically target improvements to the clinical trial interface. When possible, Sponsors should discern the usability outcomes and feedback provided by Pre-clinical validation study participants to also improve the final finished product user interface.
Pharmaceutical and medical device Sponsors should attend this presentation if they are interested learning how to successfully plan, execute, and appropriately interpret or apply the results of HF validation studies in support of clinical studies.