Blog — Clinical Pathways

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subject safety

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.

MHRA Updates EHR Remote Access Monitoring Guidance

9/21/2021

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The Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom (UK) updated their guidance document, “Access to Electronic Health Records (EHR) by Sponsor representatives in clinical trials” in September 2021. Originally released in November 2020, it did not provide adequate guidance on direct remote access of EHR. Other relevant guidance only included small sections on remote monitoring, including the March 2020 guidance describing best practices for managing clinical trials during the COVID-19 pandemic and the November 2020 guidance describing how to minimize disruptions in the conduction and integrity of clinical trials amid the ongoing pandemic.

Insufficient Dosing to Vulnerable Population Within a Clinical Trial Leads to FDA Warning Letter

5/05/2021

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New Warning Letter Issued

A warning letter was issued to Dr. Evelyn Lopez-Brignomi, M.D. this March in regards to “objectionable conditions observed during an FDA inspection conducted at her clinical site between June 8 and June 23, 2020.” This study contained pediatric subjects who are a vulnerable population which raises concern about the severity of the violation and their potential impact on subjects’ rights, safety, and welfare.

New FDA Sponsor-Investigator Warning Letter Sent Due to Insufficient CAPA

3/30/2021

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What happens when an investigator or a sponsor of a clinical trial does not comply with FDA Code of Federal Regulations? And when they do not comply what needs to be done? Inadequate responses to inspection findings are very negatively impacting. Have you wondered how they are notified they are doing something wrong?

Background

The United States Food and Drug Administration (FDA) requires entities conducting clinical trials to go through steps for approval prior to beginning the trial. They also require adherence to several regulations. When these obligations are not met, it can be detrimental to study subjects, the public, and the integrity and quality of the data. The FDA sends warning letters to clinical research sponsors, investigators and other organizations outlining the errors that were made so they can take appropriate action. (About Warning and Close-Out Letters | FDA)

Is Your Study High Quality? Investigator Warning Letter Issued

2/16/2021

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During the pandemic, onsite FDA inspections were temporarily suspended starting in March 2020 and restarted late summer. Our blog “FDA Resumes Domestic Inspections” describes the risk-based approach to remote assessments during that time period. This in part explains the long interval since the last warning letter. The first new warning letter after inspections resumed was issued to an investigator.