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In life, the purchase of a new car, or house, invokes feelings of excitement, potential value and sustainability. Being new is positive thing, with infinite possibility.
Whereas, in the clinical research industry, a new/inexperienced employee may invoke feelings of unease, and the investment of critical time and resources without prospective return. Wonderful possibility is not anticipated, rather, ability is questioned. This doubt forces the choice of experience over potential, on what is comfortable/predictable (such as the requisite two years of CRA experience for an entry level CRA position) over the unknown.
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Male breast cancer is rare, but nonetheless as deadly as for women when at the same stage of progression. Men have been traditionally excluded from breast cancer clinical trials, so any treatment for them has been developed with data from women subjects. This results in fewer FDA approved treatment options for men with breast cancer.
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What: WCG Metrics Champion Consortium (MCC) Summit
Topic: Clinical Trials Risk and Performance Management Summit Agenda
When: September 4 and 5, 2019
Where: The Loews Philadelphia Hotel; Philadelphia, PA
Book the hotel here and ask for the FDAnews rate
Registration is available here.
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The Food and Drug Administration (FDA) announced the availability of the draft guidance “E8(R1) General Considerations for Clinical Studies” for public comment. The purpose of the draft guidance is to increase flexibility of clinical trials while improving the quality of clinical trial data presented to regulatory authorities. The draft guidance originates from the International Council for Harmonisation’s (ICH) E8 draft revision. The revision is part of ICH’s Good Clinical Practice (GCP) Renovation initiative, which outlines plans to revise ICH E8 and further revise ICH E6.
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Topic: Identifying Workforce Gaps Post Risk-Based Monitoring (RBM): It’s Time to “DIG” in!
Date: August 13, 2019
Time: 1:00 p.m. – 2:00 p.m. EDT
Duration: 60 minutes
Sponsored by: Life Science Training Institute
Webinar: Live interactive session. Recording will be available for 30 days.
Sign up here.
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What does ‘C’ stand for?
Do you care whether the actions you took to try to stop an issue from recurring were completed? Does it matter if they actually worked? Of course! Deciding on actions is only part way to fixing a problem. We need to complete the actions and make sure they were effective. That's why there is the ‘C’ step in the DIGR-ACT® solution, where C stands for ‘Check’.
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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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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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Many people automatically think about drugs when they visualize clinical trials, especially if that has been their experience. Medical devices are essential for human health and it is important to understand how they are distinct from drugs. Although there are similarities, there are quite a few differences between medical device and drug or biologic clinical trials, including:
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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.