10

The paper itself describes how this is calculated (see the Methods section), but also see this Q&A at Biology.SE talking more broadly about how efficacy has been defined in these vaccine trials: https://biology.stackexchange.com/q/96941/27148 They define efficacy as the fraction of infected in the vaccine compared to placebo categories, normalized for ...


6

The formula used for vaccine efficacy is as follows: VE = (ARU - ARV) / ARU (VE: vaccine efficacy, ARU: attack rate in unvaccinated participants, ARV: attack rate in vaccinated participants) This is equivalent to: VE = 1 - RR (RR: Relative risk) The attack rate is simply the number of new cases divided by the total group size. ARV = 39 / 21,314 = 0....


4

I agree the presentation is confusing. There are 4 categories, two are the same category except separated by age. The other two categories are not separated by age. There are two gray colors; the darker one is "NHAP patients, not bedridden" (nursing home acquired pneumonia), and is the one you refer to. You'll note that only 3 categories are ...


3

I'll point out some possible situations; these are certainly not exhaustive and some can overlap, but will probably give you a better idea. Some of the terminology I'll use might be a bit US-centric, but the general principles also apply elsewhere. Phase 1 clinical trials Phase 1 trials are the first of four phases that make up a typical clinical trial ...


2

D1 means on day one of the three weekly cycles. DI is a typo. https://oncologypro.esmo.org/meeting-resources/esmo-2016/Lurbinectedin-PM01183-administered-once-D1-every-3-weeks-q3w-in-combination-with-capecitabine-XEL-in-patients-pts-with-metastatic-breast-MBC-colorectal-CRC-or-pancreatic-PaC-cancer


2

In the final stage of FDA's approval process, what is the 'agency'? What is the role of them? The agency is the Food and Drug Administration (FDA). They are an agency within the Department of Health and Human Services. As the article and quote in your question says, Although the agency isn't required to follow an advisory committee's recommendation, it ...


2

I'm afraid it would be frowned you all if I answered it by myself and took my response as a solution, but... As I mentioned in the comments section above, I found a very summarized resource on the FDA's web site. (1)FDA According to the FDA, Drug Review Steps Simplified is as follows.(This is a regular approve route. Not a shortcut-way.) BoxF1: Preclinical ...


2

You could try ClinicalTrials.gov, where you can search a massive database of clinical trials in every stage of completion.


1

Apparently some testing was conducted; it's mentioned on p. 49 in the MHRA assesment report, albeit not in a lot of detail: Laboratory testing was only conducted in a subgroup of subjects up to 28 days after each dose. The incidence of decreases in white blood cells, neutrophils, and platelets was slightly higher in the AZD1222 group compared with control. ...


1

I think 'I' represents Intravenous infusion as it is mentioned in Clinical trial information sheet.


1

The authors are fitting a regression model. It is common in regression with factors as predictors to consider one level of the factor as a "reference" level. Every other variable in the model expresses some difference relative to that reference level. Ultimately the choice of reference doesn't matter that much for the model, as long as appropriate ...


1

The followings are English translations of quotations from one commentary, written by a Japanese brain expert. (Unfortunately, the commentary itself is written in Japanese) By closely examining brain tissue samples from patients who died after taking anticancer drugs, researchers found that even in adult brains, neurons were nascent, at least in the dentate ...


1

This paper tested Ebola penetration of wet and dry surgical masks and N95 respirators. It found, "A difference in virus penetration was observed between dry (5%, 1/21 tests) and saturated (33%, 7/21 tests) samples of PPE."


1

The entire point of having a placebo control from a statistics perspective is that the only thing different between the groups is the treatment. You cannot say this is true if you also tell people which group they are in: if you do this, there are now two differences between groups, 1) Treatment vs placebo, 2) Knowing they are in the placebo group vs. ...


1

The National Research Council has explained that: “Precision Medicine refers to the tailoring of medical treatment to the individual characteristics of each patient. It does not literally mean the creation of drugs or medical devices that are unique to a patient, but rather the ability to classify individuals into subpopulations that differ in their ...


1

DI stands for diachronic: Diachronic: Over a period of time. The opposite of synchronic. This would indicate that the medication is given in a drip, not as a bolus. D1 seems to not have any standard meaning, the conclusion this answerer draws is that D1 is a probable transcription substitution for DI.


1

Favipiravir, the brand name of Avigan and was first developed in Japan. The official English translation of the PMDA's review report on Avigan's indication for influenza is here. This review report has a very unusual logic to it. In summary; It has no clinical significance for any flu tested. However, it may work against the unknown flu, but they don't have ...


1

■What is the ATMPs I didn't clearly read from the EMA's description of the ATMP, whether the ATMP is as being a "sales approval" or a "preferential treatment that lowers the bar to obtain approval". Perhaps the noun "ATMP" has three different meanings; I was confused because of the mix of these in the EMA's site. Box1. Three ...


Only top voted, non community-wiki answers of a minimum length are eligible