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On September 18th, 2024, The US Food and Drug Administration (FDA) released a final guidance document titled: “Conducting Clinical Trials with Decentralized Elements” which is intended to inform sponsors, investigators, and other clinical trial stakeholders about the proper implementation of decentralized clinical trials (DCT).
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On August 20th, 2024 the US Food and Drug Administration (FDA) issued a warning letter as a result of an FDA Bioresearch Monitoring (BIMO) Program inspection. The inspection observation was that improper dosing instructions were given to a pediatric patient. Per 21 CFR 312.60, the investigator is responsible for ensuring the study is conducted according to the protocol.
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The internet is the leading source of health information for most consumers, patients, and healthcare providers, which has led to growing concerns that the spread of misinformation on the internet will put the public at risk of using unsafe or ineffective treatments or therapies. To address the issue the US Food and Drug Administration (FDA) has updated the draft guidance “Addressing Misinformation About Medical Devices and Prescription Drugs Questions and Answers - Guidance for Industry” to inform firms about how to voluntarily address misinformation about their medical products.
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“Q&A with FDA” is the US Food and Drug Administration’s (FDA) podcast that began in 2022 which answers frequently asked questions by interviewing FDA staff members. The most recent episode was released on August 16th, 2024 titled “Real-World Data and Evidence Generation with Dr. Hilary Marston” hosted by Dr. Sara Roach interviewing Dr. Marston, the FDA’s Chief Medical Officer.
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A new draft guidance for industry was released on August 22, 2024 by the US Food and Drug Administration (FDA) on Predetermined Change Control Plans (PCCP) for Medical Devices. The draft guidance provides an in-depth history of the origins of PCCPs and how the concept of device changes not requiring new 510(k) submissions has already made in an appearance in other FDA guidances.
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The Office for Human Research Protections (OHRP), released the 2020 edition of the International Compilation of Human Research Standards, which is available here. The Standards compile more than 1,000 laws, regulations, and guidelines from 133 countries. The Standards are applicable to stakeholders in clinical research globally, including sponsors, investigators, and Ethics Committees.
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Myth: Source data needs to be redacted before it can be reviewed by a monitor for remote monitoring.
Answer: The question is, why would you redact when the patient gave authorization to use and disclose the information for the purposes laid out in the authorization and consent? Remote review is not “collecting” data; it is “reviewing” data. Also, redacting is super laborious, manual, and prone to errors.
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Join this live, interactive webinar with guest presenters from the Duke Office of Clinical Research within the School of Medicine for ‘A Case for Sponsor Monitoring Remote Access to EMRs.’ This session presents how a successful program was implemented prior to COVID-19 and then leveraged during COVID-19 to support sponsor remote review of EMRs while maintaining control and security of the subjects’ data and maintaining subjects’ privacy based on the HIPAA authorization. Learn about a case example of a successful program implementation that avoids site burden and maintains attributability to records. Explore opportunities for sites and sponsors to find similar solutions. The webinar concludes with a question and answer session.
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The FDA released new topics in the FAQ section of the guidance document for conducting clinical trials during the COVID-19 pandemic. The rapidly changing environment of the crisis has made it challenging to continue conducting and monitoring clinical trials in the traditional manner due to restrictions on travelling, dispensing investigational products, and social gathering. New questions continue to arise as the logistics of monitoring and conducting clinical trials become apparent.
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Master protocols can increase efficiency of clinical trials while reducing risks to subjects. A master protocol compares multiple different investigational products with one placebo within one protocol. An adaptive design may be built into the protocol so that a substudy could be eliminated if the data warrants. Read our blog on adaptive design for further information.
