Blog — Clinical Pathways

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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Recently, many guidance documents and draft guidance documents regarding digital health information have been released.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.

Remote Data Collection in Clinical Trials Draft Guidance

01/25/2022

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The US Food and Drug Administration (FDA) released a draft guidance “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations” for public comment in December 2021. The draft guidance provides best practices for how digital health technologies (DHT) can be used to collect and support endpoint data and what information is needed in an investigational new drug application (IND) or an investigational device exemption (IDE) application that uses DHT. DHT is a “system that uses computing platforms, connectivity, software, and/or sensors, for healthcare and related uses.”

Comment Now! RWE Data Standards for Drugs and Biologics Draft Guidance

11/30/2021

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The US Food and Drug Administration (FDA) released a draft guidance “Data Standards for Drug and Biological Product Submissions Containing Real-World Data” for public comment in October 2021. This draft guidance is published in line with the 21st Century Cures Act (Cures Act). Comment now through January 21, 2022 HERE.

Concerning Violations: Sponsor-Investigator Warning Letters

11/09/2021

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There are two recent warning letters relating to sponsor-investigators. (warning letter 1 HERE and warning letter 2 HERE). A sponsor-investigator both initiates and conducts a clinical trial, which is also known as an investigator initiated clinical trial (IIT). In both examples, the investigator used protocols internal to the institution but did not submit an Investigational New Drug (IND) application to the FDA. The drugs chosen for the protocols were approved and being used for on label use in the protocols. However, the protocols restricted what drug was being used and so could not be considered standard of care.