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On April 29th, 2024 the US Food and Drug administration (FDA) posted a news release outlining an upcoming virtual listening session June 13th, 2024 from 9:00am–4:00pm ET, on the optimal use of and processes for FDA advisory committees (Ad Com). FDA Ad Coms are intended to provide the agency with advice and recommendations from the public as well as external experts from various backgrounds. They review the safety, effectiveness, and appropriate use of products in FDA regulated research by discussing scientific, technical, and policy issues and voting on proposed future actions.
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On April 15th, 2024 the Center for Drug Evaluation and Research (CDER) of the US Food and Drug Administration (FDA) announced the establishment of the CDER Center for Clinical Trial Innovation (C3TI). Clinical trial design and conduct must be held to rigorous standards and policies in order to safeguard the well-being of trial participants and the public. These standards and policies are outlined within the ICH E8(R1) Guideline: General Considerations for Clinical Studies.
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Informed Consent Forms (ICF) for clinical trials are required to communicate the essential details of a trial to prospective participants including the procedures, the risks of using the investigational product (IP) or device, and actions the participant would be expected to take during the trial (i.e., filling out questionaries, coming in for routine visits, etc.). As clinical trials continue to evolve and become increasingly complex, ICFs must accurately explain these complexities as they can lead to confusion for the intended audience.
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The US Food and Drug Administration (FDA) published guidance on “Use of Data Monitoring Committees in Clinical Trials” in February 2024 which, once finalized, will take precedent over the FDA’s previous guide on the subject from 2006. The guidance clarifies data monitoring committees’ (DMC) relevance and importance in clinical trial oversight, and how to determine when utilizing a DMC is practical for certain clinical trials.
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On October 20, 2023, the FDA issued an investigator warning letter to Maria W. Greenwald, M.D.. The inspection was part of the FDA's Bioresearch Monitoring Program, aimed at assessing research conduct to safeguard the rights, safety, and well-being of human subjects. The investigation was conducted for several clinical studies, and there were multiple instances where the site failed to comply with investigational plans.
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What does ‘D’ stand for?
Ever find that when your team is trying to fix an issue that matters, you get a long way into the process before realizing each of you has a different idea of what the issue is? That's why we have ‘Define the issue’ as the first step of the unique DIGR-ACT® solution.
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We have some great news! Our online store is opening mid-March. As a grand opening special, all of our eLearning courses will be offered at a special introductory rate for the first 30 days. Our featured product is DIGR-ACT®, a solution for those looking to improve their critical thinking skills in relation to clinical trials. It helps clinical trial team members manage issues and risks that matter, to dig through and map information to root cause, then to come to valid conclusions on how to act effectively.
The United Kingdom (UK) notified the European Union (EU) of its intent to withdraw effective March 30, 2019, a process commonly known as Brexit. At that point, it will become a “third country” and will not follow the EU regulations for pharmaceuticals. Negotiations are underway for a withdrawal agreement. The European Medicines Agency (EMA) and the European Commission have released guidance related to pharmaceutical companies’ distribution of drugs due to the uncertainty of authorization of a withdrawal agreement.
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You have probably been in this situation before. A site prone to issues is having problems yet again, and this time it may be serious. You need to figure out what to do, and you are feeling frustrated. Your first thought might be retraining the site. After all, if they didn’t do the right thing, they must not understand what they are supposed to do. Isn’t that how we have always taken care of compliance issues? Retrain, document the training, and then hope for the best? Isn’t there something better?
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Do you ever wonder why people are not doing what you expect? How do you figure out what went wrong and what constraints are getting in the way of everything working as it should? You may have heard that you need to ask the right question, or even about the five whys. But if you have used the 5 Whys before, have you noticed that you are not confident in the results? There is a better solution to getting to root cause in a more reproducible way, to developing actions and implementing them.
