U.S. FDA Outlines Use of Patient Preferences in Device Approvals
The U.S. FDA is making good on promises to consider patient preferences in device approvals, draft guidance issued Thursday makes clear.
The 32-page document discusses the main factors sponsors and other stakeholders should consider when collecting patient preference information that may be used in the premarket review of PMAs, HDE applications and de novo requests. While submitting the information is optional, it can assist the FDA in assessing a device when multiple treatment options exist and none is clearly superior, or if patients’ views on a product’s benefits and risks are significantly different from those of healthcare providers.
Information on patient preferences may be especially useful with devices that are directly used by patients, devices intended to yield significant health and appearance benefits and life-saving, but high-risk devices, the FDA says. Devices that include novel technology or are designed to fill an unmet need may also benefit from patient preference studies, the agency adds.
Patient preference studies should incorporate the following:
- A representative patient sample with results that can be generalized;
- Differences in patients’ preferences, including those shaped by disease severity, patient age and personal risk tolerance;
- Good clinical practices;
- Effective communication of the benefit, harm, uncertainty, and risk to patients, through such techniques as presenting information in multiple formats and avoiding fractions when comparing risk levels;
- Designing the study to minimize cognitive bias;
- Critical aspects of risk, benefit and uncertainty in preferences over several relevant clinical domains;
The FDA tasks sponsors with keeping accurate case histories, including include patient diaries, assessments and other electronic patient-reported outcome tools.
The FDA anticipates using patient preference information throughout the device lifecycle, from influencing device design and shaping clinical trials to factoring into postmarket monitoring.
Companies that plan to collect patient preference information should meet with Center for Devices and Radiological Health staff early in the trial design process, the agency says. Patient preference information may be submitted as part of a PMA or other application or by an academic or patient group.