Patient-Centric Approach: PRO Used in Medical Device Clinical Trials Guidance

03/08/2022

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The Food and Drug Administration (FDA) released a guidance “Principles for Selecting, Developing, Modifying and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Clinical Evaluation” in January 2022. This and a related guidance, “Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims” from December 2009 are part of an initiative by the Center for Devices and Radiological Health (CDRH) to incorporate the use of patient-reported outcomes (PROs) in evaluating medical devices. The guidance does not replace the Patient-Focused Drug Development (PFDD) guidance series.

New Patient-Centered Drug Development Guidance – Collecting Input

03/01/2022

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The US Food and Drug Administration (FDA) released a final guidance “Patient-Focused Drug Development: Methods to Identify What Is Important to Patients” in February 2022. This is second in a series of guidance related to a patient centered approach to drug development. The first guidance in the series, “Patient-Focused Drug Development: Collecting Comprehensive and Representative Input”, was finalized June 2020. These guidance documents are aligned with the 21st Century Cures Act (Cures Act) of 2016 requirement for patient-focused drug development (PFDD). The guidance documents clarify how patient experience data collected from patients can best be used for drug development and regulatory applications. The June 2020 guidance discusses best practices for the methods of data collection that ensure accurate and representative experience data and goes further into patient experience data, which includes their experiences, perspectives, needs, and priorities.

Now Available for Purchase: Overview of ICH E8(R1): General Considerations for Clinical Studies Guideline

02/22/2022

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ICH E8(R1) is the umbrella guideline that maps to all the ICH “E” family, including ICH E6(R3), Good Clinical Practice. The revision modernizes clinical trial design, planning, management, conduct, and reporting and introduces the idea of quality as data being fit for purpose, which is ensuring the protection of study participants, the integrity of the data and reliability of the results, and the ability of the trials to meet their objectives. The key purpose is to design quality into clinical trials, which is supported by the establishment of an appropriate framework for the identification and review of Critical to Quality factors at the time of design and planning of the study, and throughout its conduct, analysis, and reporting.

Patient Engagement in Device Clinical Trials Guidance

02/15/2022

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The US Food and Drug Administration (FDA) released a guidance, “Patient Engagement in the Design and Conduct of Medical Device Clinical Studies.” The purpose is to guide industry to consider patient and caregiver perspectives on living with a particular disease or condition and how medical devices impact their lives, as well as perspectives on how a clinical trial may impact a study participant. The guidance is part of the FDA Patient Engagement Advisory Committee (PEAC) initiative to increase patient engagement in medical device clinical trials.

Digital Health Information: Applicable to HIPAA Breach Notification? Policy Statement Clarifies

02/08/2022

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Recently, many guidance documents and draft guidance documents regarding digital health information have been released. This is in response to the increase in numbers of devices used in the course of a clinical trial, including wearable devices, ePRO, eCOA, software such as apps, home monitors, etc. These devices collect health information and store or transmit it outside of the collection site. Such vendors need to be aware of how they are classified to ensure compliance with applicable regulations. If they are not directly considered a medical device, the device manufacturers and app developers may be considered vendors of personal health records (PHR) and would then need to comply with the Federal Trade Commission’s (FTC) Breach Notification Rule. The FTC released a Policy Statement to clarify the scope of this Rule.