Posted on 12/12/2021 9:28:31 PM PST by DoodleBob
The probability of success (POS) of a clinical trial is critical for clinical researchers and biopharma investors to evaluate when making scientific and economic decisions. Prudent resource allocation relies on the accurate and timely assessment of risk. Without up-to-date estimates of the POS, however, investors may misjudge the risk and value of drug development, leading to lost opportunities for both investors and patients.
...The trials range from January 1, 2000, to October 31, 2015, the latter being the date that we received the data set... Of these, 34.7% (141,086) are industry sponsored and 65.3% (264,952) are non-industry sponsored.
...
Table 1 contains our estimates of the aggregate POS for each clinical phase across all indications...We find that 13.8% of all drug development programs eventually lead to approval...Table 2 contains phase and overall POS estimates by therapeutic group...
Therapeutic group.....Overall POS, %
Vaccines.........................33.4
...
...We find that the median clinical trial durations are 1.6, 2.9, and 3.8 years, for trials in Phases 1, 2, and 3, respectively....By summing up the individual durations across Phases 1 through 3 and across therapeutic area, we find that the median time spent in the clinic ranged from 5.9 to 7.2 years for non-oncology trials...
(Excerpt) Read more at academic.oup.com ...
As I've said repeatedly, if people want to take the COVID19 shots because of comorbidities or age etc., then that's a personal choice and I'll never give you grief.
At the same time, there should be acknowledgement that these shots were released with virtually no clinical trials being undertaken. And yet, we are supposed to ignore hard data that only about one-third of all vaccines make it through four phases of clinical trials, and that it take nine years at the median to obtain approval.
POS is the appropriate acronym for the mRNA and adenovirus jabs.
maybe they used to take 9 years. Reality is, there are now two years of clinical data across 8 billion and counting vaccinations and 269 million infected. To get some perspective, the first computer mouse was invented in 1991. 30 years later, it’s touchscreen, voice command, motion control headsets, and spacelaunches calculated on laptops. Medical science wasn’t left behind in the ability to identify and crunch numbers.
So it becomes not so much length of trials, as ability to aggregate data in a meaningful way for real-time results.
It’s this same ability that led to monoclonals being deemed a preferential treatment (and with wide acceptance) less than 6 months after Trump first ‘introduced’ them to the gen pop last November... There are risks to monoclonals, too, but same as vaccines, the risk from disease is worse
If what data they do have now on their ‘trials’ is legitimate and substantively supports the efficacy of these hastily approved ‘vaccines,’ why do they want over 50 years to fully release that data?
And yet, they want over 50 years to release that data that was developed during a period before the vast vaccinated numbers you cite for now.
It took 74 days to create a vax.
Think about that one.
A vital part of clinical trials is consistent, accurate, disciplined, and timely record-keeping on not just the test subjects getting the serum but those getting the placebo. All subjects get checked out at designated intervals, vitals are recorded, side-effects are documented, boundary cases are reviewed, and recoveries and deaths are verified. That boring yet mission-critical data collection process is, in many ways, the only way a robust statistical analysis can be performed to determine if the serum works as intended without bad side effects.
The placebo recipients in the Moderna EUA trials (that, btw, ran a few months in 2020) were offered - and received - the actual shots. That destroyed any ability to continue with the next phase of the clinical trial. Furthermore, there was no follow-up in a consistent/clinical trial-like manner with any of the test subjects.
Compounding these problems is the rabid political science around recipients who got sick, "died suddenly" or "died unexpectedly" and the demonization of anyone who suggests that these shots may have some nasty long-term side effects. To be sure, there are political axes to grind on both sides of the aisle. But what happens if two years after getting two doses then a booster (and, by the way, even the boosters aren't getting long-term trials either) everyone's big toe falls off?
We do not have two years of clinical data. We have anarchy, a plethora of small biostatistical studies trying to make heads or tails out of these shots with no rigorous long-term analysis, name-calling in the media and society, and now we have an Administration using OSHA to do their bidding.
Again, if people want to get these shots, more power to them. It's their choice. If they don't want to get them, they have more than enough of a clinical basis to take a pass.
Ping for your consideration.
Trial start date April 29, 2020. Estimated completion date May 2, 2023 -- Offical Title: A PHASE 1/2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, IMMUNOGENICITY, AND EFFICACY OF SARS-COV-2 RNA VACCINE CANDIDATES AGAINST COVID-19 IN HEALTHY INDIVIDUALS
Phase 1/2/3 run concurrently and will be done in 2023.(In Healthy Individuals) There's usually a Phase 4. Do you feel like a guinea pig? You should. Unless you're a PureBlood.
Unless they had been working on one BEFORE the news broke out about it.
A six-month study using this trial was published. Interestingly, During the blinded, placebo-controlled period, 15 participants in the BNT162b2 group and 14 in the placebo group died; during the open-label period, 3 participants in the BNT162b2 group and 2 in the original placebo group who received BNT162b2 after unblinding died. None of these deaths were considered to be related to BNT162b2 by the investigators. Causes of death were balanced between BNT162b2 and placebo groups (Table S4).
So while preventative Efficacy was sustained, fatalities were equal across both groups.
Either way, do you trust such a jab?
No......and if they were working on a vaccine for it BEFORE the news came out two years ago, then WHY? How would they know?
Citing numbers includes:
Using Worldometer’s latest “data” — with quotes around the word because the pretense at rigor in data taxonomy, collection, analysis and reporting is questionable — one finds:
( 5,261,659 deaths worldwide / 7,911,098,750 ) x 100 = circa 0.067 %
In plain words, the “pandemic” dead comprise less than one-tenth of one percent of the general population worldwide, in a world where about one percent of a population dies off each year as a rule of thumb.
As to the “two years of clinical data,” the mRNA vaccines have been given under the “emergency use authorization” since last December, in phase three clinical trials which will not be complete until the coming years. Even so, our FDA wants to reply to FOIA requests by taking decades to release “data.” And the “data” from the ongoing clinical trials are also not currently available.
Or perhaps you have the data? Which data do you trust? Please cite links to your data.
It is fascinating that so much reporting, positive and negative, is about telling what the future will bring. Other reporting, positive and negative, chooses some but not all data.
Indeed, that is what we are “supposed” to ignore.
We also are “supposed” to ignore critics of warp speed, the estimations from companies which have no legal liability for their mRNA “emergency use” products, and “believe” the massive marketing.
Skepticism and dissent are not rewarded by those who would have us “ignore” so much.
“In plain words, the “pandemic” dead comprise less than one-tenth of one percent of the general population worldwide, in a world where about one percent of a population dies off each year as a rule of thumb.”
You are using real-time figures that have the advantage of 8 billion vaccinated cutting the deaths without mentioning the benefit of the 8 billion vaccines. But for some hard reality, let’s go back to last year - to an unvaccinated world, with a less infectious and less lethal Alpha compared to this year’s Delta, and compare 2020 figures to the current 20% ICU mortality USA 2021:
“Peshawar, Pakistan, from April to August 2020. ICU mortality 75-94%
The overall mortality was 77%. Non-invasive ventilation (NIV) was administered to 61.8% of patients. Mortality was higher for invasive mechanical ventilation (IMV) (93.6% vs 66.7%, p<0.001) and for over 60 years (87.3% vs 72.3%, p=0.019). Mortality without co-morbidities was 75.2%.
AND, further down, same link:
“Studies have reported nearly 100% mortality amongst patients on invasive mechanical ventilation (IMV) during the peak of the pandemic [10]. Mortality among patients on IMV was 88.6%, 97%, 43%, 31%, 88.8%, 22%, and 40%-60% in New York [7], China [11], UK [12], Spain [13], Australia [14], and India [15], respectively. With time, the mortality in ICUs declined to around 40% [4]. In the early days of the outbreak, there were no international guidelines for managing patients admitted to the ICU, and the rationing of resources based on local policies in overwhelmed ICUs might have added to divergent data”
There are 60 million ‘expected’ deaths any given year. Of that, 20% or 9 million are from starvation. Another 20% are from tropical diseases/TB/AIDS. Heart disease is the number one killer world-wide - 8 percent. Covid is about to eclipse heart disease as the number one killer, as it now accounts for 8.3% of ‘expected’ deaths. That’s more than those that are ‘expected’ to die from COPD, diabetes, lung cancer and Alzeheimers combined. But the pandemic profiteer siren song of “circa 0.067 %” sure sounds cozy, yeah?
https://www.theworldcounts.com/populations/world/deaths
“As to the “two years of clinical data,” the mRNA vaccines have been given under the “emergency use authorization” since last December, in phase three clinical trials which will not be complete until the coming years. “.
The phase 3 trials concluded Nov 2020. ‘not completed’ is pandemic profiteer misinformation based on an initial projected date instead of the actual date.
Nov 18, 2020:
https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-conclude-phase-3-study-covid-19-vaccine
The claim that COVID-19 vaccines have skipped animal trials is also untrue .
“Oxford University confirmed the vaccine it created with AstraZeneca has undergone animal trials in the UK, US and Australia (here). Pfizer and BioNTech released information in Sept. 2020 about the effects of their mRNA vaccine in mice and non-human primates (here).
Moderna has released similar information (here, here), as has Johnson & Johnson (here).
https://www.reuters.com/article/factcheck-covid-vaccines-idUSL1N2M70MW
the claim that vaccines need time to develop and be studied was true for 20th century first=generation vaccines that needed to be grown in eggs and other medium, introducing the possibility of allergies and cross-reactivity. This was labor and time intensive, and meant low batch rates - an inability to respond to a pandemic while limiting vaccines to those who weren’t allergic to eggs (or mice). Additionally, first generation science didn’t have the computing and communication power of the 21st century, much less the ability to access research on the internet with results in seconds. It took 20 years after the invention of a computer mouse for the appearance of Wiki and by that time the mouse was obsolete.
mRNA vaccines are a second=generation, 21st century product building on 30 years of research begun by Katalin Kariko, now known as the ‘mother of mRNA vaccines’. The first human proof of concept trial with a mRNA (rabies) vaccine was back in 2017. (Curevac AG, 2017). In the first year of the pandemic, cargo-ship loads of money were thrown at the finest medical research universities around the world who were -already- developing mRna candidates, enabling faster coordination and information sharing, as well as safer development and production of an effective vaccine completely in a laboratory, without the use of eggs, meaning quicker time to extensive animal trials, which were conducted prior to and concurrent with, human trials.
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