andrew_gelman_stats andrew_gelman_stats-2010 andrew_gelman_stats-2010-314 knowledge-graph by maker-knowledge-mining
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Introduction: Sanjay Kaul wrotes: By statute (“the least burdensome” pathway), the approval standard for devices by the US FDA is lower than for drugs. Before a new drug can be marketed, the sponsor must show “substantial evidence of effectiveness” as based on two or more well-controlled clinical studies (which literally means 2 trials, each with a p value of <0.05, or 1 large trial with a robust p value <0.00125). In contrast, the sponsor of a new device, especially those that are designated as high-risk (Class III) device, need only demonstrate "substantial equivalence" to an FDA-approved device via the 510(k) exemption or a "reasonable assurance of safety and effectiveness", evaluated through a pre-market approval and typically based on a single study. What does “reasonable assurance” or “substantial equivalence” imply to you as a Bayesian? These are obviously qualitative constructs, but if one were to quantify them, how would you go about addressing it? The regulatory definitions for
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1 Sanjay Kaul wrotes: By statute (“the least burdensome” pathway), the approval standard for devices by the US FDA is lower than for drugs. [sent-1, score-0.215]
2 Before a new drug can be marketed, the sponsor must show “substantial evidence of effectiveness” as based on two or more well-controlled clinical studies (which literally means 2 trials, each with a p value of <0. [sent-2, score-0.839]
3 What does “reasonable assurance” or “substantial equivalence” imply to you as a Bayesian? [sent-6, score-0.058]
4 These are obviously qualitative constructs, but if one were to quantify them, how would you go about addressing it? [sent-7, score-0.221]
5 The regulatory definitions for “reasonable assurance of safety and effectiveness” are provided below. [sent-8, score-0.733]
6 Evidence for Safety Are there reasonable assurances, based on valid scientific evidence that the probable benefits to health from use of the device outweigh any probable risks? [sent-9, score-1.586]
7 Evidence for Effectiveness Is there reasonable assurance based on valid scientific evidence that the use of the device in the target population will provide clinically significant results? [sent-10, score-1.598]
8 What are the costs and benefits of approving or not approving a new drug or device? [sent-12, score-0.697]
9 I’d be interested in the opinions of some real experts, such as: John Carlin, Chris Schmid. [sent-14, score-0.055]
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Introduction: Sanjay Kaul wrotes: By statute (“the least burdensome” pathway), the approval standard for devices by the US FDA is lower than for drugs. Before a new drug can be marketed, the sponsor must show “substantial evidence of effectiveness” as based on two or more well-controlled clinical studies (which literally means 2 trials, each with a p value of <0.05, or 1 large trial with a robust p value <0.00125). In contrast, the sponsor of a new device, especially those that are designated as high-risk (Class III) device, need only demonstrate "substantial equivalence" to an FDA-approved device via the 510(k) exemption or a "reasonable assurance of safety and effectiveness", evaluated through a pre-market approval and typically based on a single study. What does “reasonable assurance” or “substantial equivalence” imply to you as a Bayesian? These are obviously qualitative constructs, but if one were to quantify them, how would you go about addressing it? The regulatory definitions for
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Introduction: Someone who works in statistics in the pharmaceutical industry (but prefers to remain anonymous) sent me this update to our discussion on the differences between approvals of drugs and medical devices: The ‘substantial equivalence’ threshold is a very outdated. Basically the FDA has to follow federal law and the law is antiquated and leads to two extraordinarily different paths for device approval. You could have a very simple but first-in-kind device with an easy to understand physiological mechanism of action (e.g. the FDA approved a simple tiny stent that would relieve pressure from a glaucoma patient’s eye this summer). This device would require a standard (likely controlled) trial at the one-sided 0.025 level. Even after the trial it would likely go to a panel where outside experts (e.g.practicing & academic MDs and statisticians) hear evidence from the company and FDA and vote on its safety and efficacy. FDA would then rule, consider the panel’s vote, on whether to appro
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Introduction: Neil Malhotra writes: I just wanted to alert to this completely misinformed Politico article by Roger Simon, equating sampling theory with “magic.” Normally, I wouldn’t send you this, but I sent him a helpful email and he was a complete jerk about it. Wow—this is really bad. It’s so bad I refuse to link to it. I don’t know who this dude is, but it’s pitiful. Andy Rooney could do better. And I don’t mean Andy Rooney in his prime, I mean Andy Rooney right now. The piece appears to be an attempt at jocularity, but it’s about 10 million times worse than whatever the worst thing is that Dave Barry has ever written. My question to Neil Malhotra is . . . what made you click on this in the first place? P.S. John Sides piles on with some Gallup quotes.
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