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 ...
7
Is there any truth behind chemotherapy actually curing Multiple Sclerosis?
Unfortunately, no. Multiple sclerosis (MS) is a chronic illness - meaning that it cannot be completely cured. There are, however, various therapeutic options for patients suffering from MS. Some of them include chemotherapeutics - but not as the first-line treatment.
The important ...
6
I have found a couple of papers which debunk this myth. The links here go directly to free PDF copies and there are DOI links in the references in case the PDF links die.
The most recent paper I can find at the moment is by Hilton, et al. (2006).
The recent controversy surrounding the safety of the measles, mumps, and rubella vaccine (MMR) has ...
6
Original Answer
This comes from my high-school chemistry book (in German):
Hexanhexol (sorbitol) is common in apples, cherries and other fruits. The sweet taste comes from the OH-Groups within the molecule. […]
Sorbitol is half as sweet as sugar (glucose), but does not cause carries.
Furthermore, foods containing sorbitol feel cool in the mouth, as
...
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....
6
Of the three vaccine products that have been approved or had emergency use authorization in the United States, all used saline placebo in the clinical trial.
From the Pfizer Polack et al paper:
With the use of an interactive Web-based system, participants in the trial were randomly assigned in a 1:1 ratio to receive 30 μg of BNT162b2 (0.3 ml volume per dose)...
5
It appears that melatonin decreases blood pressure in a way that occurs nocturnally in normal persons. Interestingly, it is being investigated as a possible anti-hypertensive in Type 2 diabetics. It doesn't seem to have any undesirable side effects, making it an ideal anti-hypertensive.
In patients with diabetes the mean BP during sleep was lower on ...
5
There are the following newer studies which are related to that one from 1990:
1992: Usefulness of predischarge electrophysiologic study in predicting late outcome after surgical ablation of the accessory pathway in the Wolff-Parkinson-White syndrome,
1992: Diagnosis and localization of accessory pathways.
The WPW syndrome is a curable disease. The ...
4
If a drug produces noticeable side effects, it is likely that studies will suffer from an unblinding effect which will cause overstatement of efficacy of the drug. This is because in a properly blinded study, the placebo effect is the same* for both the active drug and the placebo, so we can calculate the true efficacy by subtracting*. Unblinding causes the ...
4
Your interpretation is basically correct.
The formal definition is:
https://prsinfo.clinicaltrials.gov/definitions.html#IntPurpose
Primary Purpose *§ Definition: The main objective of the
intervention(s) being evaluated by the clinical trial. Select one.
Treatment: One or more interventions are being evaluated for treating a disease, syndrome, ...
4
I don't think they are both specific terms that will apply consistently across all studies, you will have to use the surrounding context.
"Data lock" typically means that the data themselves in some sort of database are no longer being edited and are ready to be analyzed: that is, they have been recorded, checked for accuracy, etc. to create a "final" ...
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 ...
4
Two facts you need: first, clinical trials have very strict rules for who can be in them. Second, some trials are "drug A vs placebo" while others are "Drug A vs Drug B" or "Drug A vs Drugs A and B together" not to mention variations in dose etc. It's not all a matter of "we won't treat half the participants."
I was in ...
4
The AstraZeneca COVID-19 vaccine approved by EU and UK regulatory authorities used a meningitis vaccine as the control in phase 2/3 trials.
From the methods section of their paper:
Participants were randomly assigned to receive either the ChAdOx1 nCoV-19 vaccine or the quadrivalent MenACWY protein-polysaccharide conjugate vaccine. MenACWY was used as a ...
3
This entire study was observational; they refer to the entire group as the "observation cohort" but they selected a subset of cases who received a certain treatment to complete their further analyses. Since they don't talk further about the "observational cohort" you can mostly ignore it for interpreting their results, it is only important in the context of ...
3
You would want to talk to the staff who are recruiting patients; I'm not aware of any such trials that have started anywhere yet. I would expect you would have access to most of those things depending on what your definitions are of private time and physical activity.
As far as asking questions, just be direct and define your terms. "Can I bring my computer ...
3
Looking at this from the perspective of an infectious disease epidemiologist, the kind of person who often reads (and occasionally runs) studies of this type, I'm skeptical. A number of reasons why:
The only results are a synopsis. More details and data are apparently available, but there is no manuscript, and their "Transparency Policy" has a lot of ...
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
One might wonder why they gave an ambiguous and questionably relevant figure like "reduces virus by 92%" rather than saying "people recovered more quickly" or something like that. The answer is that in reference 1, which used real-world measures of cold severity and duration, the drug was a total failure. You can see this by looking on the results tab at the ...
2
The authors did an experiment with two independent variables: group and region. The groups are "schizophrenia" and "no schizophrenia" (controls). The a priori regions were the frontal cortex, anterior cingulate, and hippocampus (they also had exploratory analyses of other regions).
Their study was a PET scan, measuring [11C]UCB-J as a marker for synaptic ...
2
The range of symptoms for people infected with SARS-CoV-2 are extreme. There are reports of asymptomatic children with CT scans showing viral pneumonia.
Among the paediatric patients in our study, just under a third were asymptomatic. Moreover, a fifth had pneumonia only and needed radiographic examination to be identified.
With respect to the question ...
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
From https://clinicaltrials.gov/ct2/about-studies/learn#WhatIs:
A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies.
Note that unlike what the quote ...
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
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
Apparently some testing was conducted; it's mentioned on p. 49 in the MHRA assessment 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. ...
2
Full Background
The full-text of the study that Dr. Goldstein discusses is available online at:
https://www.ahajournals.org/doi/10.1161/STROKEAHA.120.032995
Chen MH, Tsai SJ, Su TP, Li CT, Lin WC, Chen TJ, Pan TL, Bai YM. Increased Risk of Stroke in Patients With Obsessive-Compulsive Disorder: A Nationwide Longitudinal Study. Stroke. 2021 May 27:...
2
Two things:
Clinical trials are generally double-blinded, meaning that neither the subjects nor the researchers know what the subject is receiving, and
Potential ethical issues are considered ahead of time by both the researchers as well as Human Subject Review Committees who have to approve the research protocol.
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
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.
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