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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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On September 18, 2023, the U.S. Food and Drug Administration (FDA) released a draft guidance titled Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence to provide further detail on the accepted types of confirmatory evidence used to support the results of one adequate and well-controlled clinical investigation.
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On September 6, 2023 the US Food and Drug Administration (FDA) issued a bulletin announcing three new draft guidances regarding the FDA’s Center for Devices and Radiological Health’s (CDRH) 510(k) premarket submission program to verify that the medical device to be marketed is substantially equivalent to a legally marketed device as medical devices continue to become more complex and innovative.
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What does ‘A’ stand for?
Don't waste time on root cause analysis, at least not if you won’t use the results! Proper root cause analysis takes effort and resources, and you need to use the output to determine actions to try to stop the issue recurring. This is the ‘A’ step of the DIGR-ACT® solution. Having dug into the issue, you now need to ‘Act’ on what you found.
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The US Food and Drug Administration (FDA) released an updated guidance, “Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency”. As clinical research professionals navigate the long haul new normal, many are wondering if the remote monitoring that occurred during the pandemic shutdowns was adequate to meet regulatory requirements. The FDA continued to update the guidance as new questions arose. The new question added to the Questions and Answers section of the guidance is:
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What does ‘R’ stand for?
We're all in a rush, and we want to fix issues quickly. But often, by assuming too much, we might reach the wrong conclusion. The cause that we used root cause analysis tools to discover is actually incorrect. Once we have the (wrong) cause(s), we may rush off and take action to fix it. But if it's the wrong cause, it is wasted effort and you rushed - only to go slow. Like if your taxi doesn't show, you might decide never to use that company again because they are unreliable - when the real problem was that you gave them the wrong pick-up address.
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What does ‘G’ stand for?
W. Edwards Deming said, "If you can't describe what you're doing as a process, you don't know what you're doing!" Many people don't naturally think of work as a process but thinking of it that way can help you uncover what might be an earlier cause of something going wrong. Maybe your normal process for grocery shopping is to write a shopping list and take it with you to the grocery store to make sure you get all the items. But today, you get home and realize you are missing several items you needed. As you think through the process steps, you realize you had written on the other side of the list and had forgotten to take a look at the store.
Going step-by-step through the process led you to a possible cause that you could investigate further. This is why ‘Go step-by-step’ is part of the DIGR-ACT® solution - the 3rd step.
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You have probably heard of the Five Whys approach to getting to root cause. ‘Why’ is a good question to ask - but not until you've dug around for more information first. After all, you are soon to find additional questions, such as: When did the problem start? - and - Where exactly is the problem? The ‘I’ step in the DIGR-ACT® solution helps through ‘Is - Is Not’ questions. They can help lead you to define the issue better but may also point you in the direction of the root causes.