Posted 31 August 2020 | By
The new draft was jointly issued by the Center for Devices and Radiological Health and the Center for Biologics Evaluation and Research. The document lays out general principles for manufacturers on the selection, development and modification of instruments to capture patient-reported outcomes (PROs). FDA has developed a suite of guidance documents related to (PROs) in drug and medical device development; the new draft adds to these documents by clarifying what to consider when selecting a tool to measure PROs.
Such instruments, said FDA in the draft guidance, “facilitate the systematic collection of how patients feel, function and survive as valid scientific evidence to support the regulatory and healthcare decision-making process. The patient voice, said the agency, should be integrated throughout the total product lifecycle.
Such PROs as patient diaries, visual analog scales, and symptom measures can be measured by PRO instruments; more extensive multidomain questionnaires can also be used in measuring health-related quality of life. Such measures can also capture certain aspects of the patient experience, such as pain and anxiety, that cannot be ascertained with external observation.
The guidance applies to PRO instruments used across the product life cycle to evaluation medical devices, but “does not detail the methods and steps of developing, modifying, or adapting a PRO instrument.”
General considerations in PRO instrument use for medical device evaluation outlined in the guidance include, first, defining the concept of interest which the PRO instrument is designed to measure. Sponsors should also clearly identify the PRO’s role as a study endpoint, and show evidence that the chosen PRO instrument does assess the intended concept of interest. Labeling should include resulted captured by the PRO.
Sponsors should also ensure PRO instruments are fit-for-purpose, so the concept being measured should be meaningful to patients and a change in that concept of interest should also be meaningful.The evidence should support the use of the PRO as it is laid out in the study protocol and statistical analysis plan.
The draft guidance also details best practices for the least burdensome selection and adaptation of PRO instruments. “Measure concepts important to patients,” said FDA in the guidance, adding that “Assessing outcomes that patients find meaningful may reduce the collection of less important PROs, thereby limiting the unnecessary burden on patients.”
Also, instruments used for PROs should be understandable to patients, according to the draft guidance. FDA encourages the use of plain language, and notes that sponsors should consider offering PRO instruments in different languages so that patient experiences of individuals with limited English proficiency and health literacy are also captured. The agency’s voluntary Q-submission program can be used for sponsors to interact with staff “to help determine the appropriateness of the cognitive interview approach.”
Sponsors, says FDA, should be clear about what role the PRO instrument will play in the clinical study protocol and statistical analysis plan. The strength of evidence the agency requires in support a PRO’s measurement properties will be proportional to the role that PRO instrument will play in the study protocol and analysis plan.
The agency also encourages sponsors to be in touch with FDA to sort out the PRO’s role and relevance to the benefit-risk assessment during the pre-submission process, before investigational device exemption submission and conduct of a pivotal study.
Sponsors can often save resources and time by using (or modifying or adapting) an existing PRO instrument, so long as the instrument would still be relevant and reliable. When adapting an existing instrument, consideration should be given to how technological advances may have changed the patient experiences being measured in a given PRO instrument.
The draft guidance also encourages sponsors to consider using real-world evidence to generate validity evidence for PRO instruments, and to form collaborative relationships in the pre-competitive space. “Collaborative development of a PRO instrument may also engender broader acceptance of results due to fewer concerns about bias in assessing the relevant aspects of the condition or its treatment or management of patients,” said FDA in the draft guidance. “Sponsors should consider submitting PRO instruments for qualification under the Medical Device Development Tools (MDDT) Program.”
The draft guidance, which is open for consultation through October 2020, also includes a glossary that will be published on FDA’s website once the guidance is finalized.
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FDA releases draft guidance on PROs for device manufacturers - Regulatory Focus
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