How clinical trials are designed
Clinical trials help us learn more about ways to prevent or treat medical conditions. Research must show a study medicine is safe and effective before it can be approved for use.
Without these clinical research studies and the volunteers who take part in them, modern medicine would not exist.
We first test a study vaccine or study medicine with a small group of clinical trial participants to understand its safety.
If the safety is acceptable, we then test the study vaccine or study medicine with a larger group of people to understand the efficacy and continue to look at safety.
This series of clinical trials unfolds across four main phases.
Clinical trials start with a protocol. A clinical trial protocol is a detailed plan that explains the purpose of the clinical trial and how it will be run.
It includes:
the length of the clinical trial
nformation about who can participate
the study medicines, procedures, and tests in the clinical trial
how side effects will be tracked, managed, and reported
the schedule of study activities
the rules that must be followed
The protocol will also describe whether the clinical trial:
- uses randomization
- is controlled
- uses blinding
Randomization
Participants are assigned to different treatment groups in a clinical trial by a process called randomization. Randomization means that participants are assigned to a treatment group by chance (like flipping a coin) rather than by choice.
Randomization is one way to help avoid bias in a study. For example, it helps ensure that people of the same sex or age are not all assigned to the same treatment group.
A controlled trial is a clinical trial that includes a comparison (control) group. In controlled clinical trials, participants are put into groups that receive the study medicine or a ‘comparator.’ We learn about the effectiveness and safety of the study medicine by comparing the experiences of the participants who receive the study medicine with those who receive the comparator.
A common example of a comparator is ‘standard of care,’ the established treatment that is currently used for a condition.
In a ‘double blind’ controlled trial, placebos are used to prevent the participant and study team from knowing whether the participant is receiving the study medicine or the comparator. A placebo does not contain any active ingredients, but the study medicine and placebo look alike. Learn more about single-blind and double-blind trials below.
Single-blind or double-blind clinical trials
Clinical trials could be single-blind or double-blind.
In a single-blind trial, the participants do not know whether they are receiving the study medicine or placebo, but the researchers know.
In double-blind trials, neither the participants nor the researchers know whether the participants are receiving the study medicine or placebo. (If necessary, such as for a safety reason, the researchers can find out what a participant has received.)
Clinical trials use blinding to help prevent bias. This way, the awareness of which treatment group a participant is in does not influence the participant or the study team.
All clinical trials are ‘unblinded,’ either after they are complete or when blinding is no longer necessary. When a study is unblinded, the assigned treatment group for each participant is revealed.
See more here: pfizerclinicaltrials.com
Header image: World Trademark Review
Editor’s note: PSI wishes to make it clear this is Pfizer’s own document and admits it can take up to ten years to bring a vaccine to market.Â
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Alan
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I would like to see Pfizer’s protocol for their Covid vaccine.
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Saeed Qureshi
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It is important to note that medical/pharmaceutical experts do not realize that clinical trials, as conducted and described, are NOT scientific. Clinical trials, as described in this article as well, are a survey (marketing) exercise. In short, it is an exercise to compare two or more things, considering that their characteristics (good or bad) are known and established a priori. The survey part (aka clinical trials) comes AFTER establishing the efficacy and safety of the items – the actual science part.
To conduct the survey (or the clinical trials), one must have an illness defined objectively with a measurable end-point and a scientifically valid test to monitor the end-point. This test then becomes the basis of the survey.
Consider the example of COVID (or virus) and vaccines. First, there has to be an objective and measurable end-point and a scientifically valid test for COVID (or the virus), which are not available! Without such, it is impossible to monitor the illness, let alone treatment, including the vaccines. Surveys or clinical trials are not relevant or useful at this time – period. It is not an opinion but a scientific fact.
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Alan
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You say the trials are to show a relationship between two or more things. They are to show the relationship between two things, for example it might be how a vaccine reduces the death rate from a disease. But in the case of Covid we were told the wearing masks prevent both the spread and infection, and social distancing and lockdowns were important. The trials were done when all the other measures were in place, and if they had an effect, then they would influence the trials and the benefits of the vaccine would have to take this into account, ,making them even less befneficial.
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Saeed Qureshi
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Alan:
You have a valid point. However, I described the concept and practice of the clinical trials in a very short and simple version. Going into any further detail, even slightly, will show how unscientific and bizarre the clinical trial practices are.
For example, when a generic product is approved, it is approved based on clinical trials by comparing the generic against the innovator’s product. The comparison uses statistical analysis called cross-over design. It is a form of Analysis of Variance (ANOVA) to compare the variability or variance in the two tested PRODUCTS (Are you impressed with the vocabulary?). However, the study design (clinical trial) cannot determine or compare variabilities of the products because they get buried within human subjects’ variabilities.
In a non-technical language, a scientifically valid comparison (for safety, efficacy, and quality) of drug products has never been conducted. However, every authority worldwide, including FDA, makes claims contrary to it.
The more I study the details of the clinical trials, the more I get frustrated and depressed. Nothing seems to be correct and scientific. COVID and vaccine development may compete for the top prize.
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Tom
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More big pharma lies. The trials are designed with the minimum requirements to show the drug/vaccine/injection is not toxic right off the bat and to get the quickest approval for the least cost. Trials are lazy, contrived and planned to give the best RRR, or relative risk reduction verses the more stringent real world ARR, absolute risk reduction which is what you should care about when taking any drug.
The mRNA trials are beyond a joke. They were not really blind, were far too quick, used only the healthiest specimens, and only about 15% of the data metrics were released to the public. The current stage of trials was supposed to run into 2023, but much of the control groups have been injected. You call that legal and reliable? Plus, recently they have added at least 5 new ingredients that were not specified in the original documents for makeup. And the proposed 3rd injection has never been given any trial study yet they want to use it anyway. If you still trust pfizer and moderna, you deserve the agony they will provide you.
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Alan
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The point about RRR and ARR is very important but when do we ever hear this from politicians, the MSM and “experts”. We certainly never here it from the vaccine manufacturers. I doubt than many people would understand the difference because the education systems have been dumbed down so much.
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