-
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).
-
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.
-
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 To address the issue the US Food and Drug Administration (FDA) has updated the draft guidance “Addressing Misinformation About Medical Devices and Prescription Drugs Questions and Answers - Guidance for Industry” to inform firms about how to voluntarily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.
-
“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.
-
A new draft guidance for industry was released on August 22, 2024 by the US Food and Drug Administration (FDA) on Predetermined Change Control Plans (PCCP) for Medical Devices. The draft guidance provides an in-depth history of the origins of PCCPs and how the concept of device changes not requiring new 510(k) submissions has already made in an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.
-
The Food and Drug Administration (FDA) released a final guidance “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank.” It clarifies how the FDA determines the “responsible parties” have submitted registration information when required, that the information submitted is factual, and when noncompliance results in civil money penalties.
-
Change is coming again. Expected updates to ICH GCP E6(R2) and ICH E8 support the agility and adaptability we need to reach the levels of study design, management, and conduct closest to the data and subjects. Taking these theoretical concepts into flexible, reliable, and accountable practices is the next step in more effective trials.
-
During the pandemic, it has become evident that we must continue to consent COVID-19 patients into clinical trials as we work to discover treatment options and better understand other aspects of the disease. Because of isolation restrictions, it is more cumbersome for all involved to conduct the informed consent process as we are accustomed. The investigator or delegate is likely not permitted into the isolation room to discuss the aspects of the trial with the potential subject. This leads to barriers to their ability to see important facial features communicated during a conversation.
-
The International Organization for Standardization (ISO) is a network of national standard bodies that develop voluntary standards, some which are applicable to clinical research. Some countries or organizations adopt ISO standards as requirements. ISO standards are reviewed every five years, and it takes approximately three years to develop a new standard.
One important standard in global clinical research is ISO 14155: Clinical Investigation of Medical Devices for Human Subjects – Good Clinical Practice. ISO 14155 has been updated to the third edition and released in July 2020.
-
The Association of Clinical Research Professionals (ACRP) interviewed Sandra “SAM” Sather on “Effective Quality Risk Management as a Mindset” July 8th. An ACRP Fellow, SAM shared her expertise on why the industry frequently misunderstands what is meant by risk-based monitoring (RBM) and quality systems. There is a misconception that clinical trials will either be done with RMB or traditional 100% SDV monitoring, when all trials need to have the approach of being based on risk.
