A new product to be launched into the market concerning human health isn’t offered to the public as soon as they are invented. They need to be studied first through various lab-based trials and preclinical trials then they are tested on volunteered human subjects before being officially launched into the market. A clinical trial is an investigation that is done right after the preclinical trials on animal subjects.
The meaning of the Clinical trial can be understood from the official Clinical trial definition which includes any investigation done on human subjects intended to discover or verify the clinical, pharmacological, and other pharmacodynamic effects of the product to be investigated. And to identify any adverse reactions caused by the product investigated, and to study absorption, distribution, metabolism, excretion of a product to be examined with the objective of finding out its safety and efficacy.
The clinical trials have different sets of criteria and use, they can be categorized into four major types, and they will be discussed briefly in this article, which will give an overview regarding clinical trials.
Clinical Trial Participation Updated 2020
For different types of clinical trials, there are specific eligibility criteria to register, such as the person may need to have certain medical conditions, be of specific gender or age group to meet the criteria of participating in a specific clinical trial, which will be assured by the clinical trial manager. Patients who want to volunteer need to have a clear understanding of the potential benefits and risks of participating in that specific clinical trial before the clinical trial registration.
The patients might be benefitted in several ways, such as the patients may benefit from the new procedures and therapies which couldn’t be obtained from the previous medications available in the market earlier. The cost of the new drugs or the diagnosis might be waived by the institution carrying out the clinical trial. Or just simply the satisfaction of participating in the research breakthrough which will benefit thousands of future patients and a clinical trial certification. On the other hand, patients may also face drawbacks, such as not getting benefits from the medication and hence worsening of the health.
The patient may also be subjected to various adverse effects. Unlike the standard treatment, clinical trial treatments may require a longer time. Such potential benefits and risks of the treatment along with the purpose of the trial and procedures will be written in the informed consent documents which are a part of the clinical trial design. Which will be provided by the Clinical trial assistant to the volunteering human subject patients. There will also be through discussion by the patients and clinical trial coordinator to clear out further queries regarding the clinical trial protocols.
Clinical Trial Procedure Updated 2020
While carrying out the study, participants are generally divided into two groups. One group is known as the treatment group which receives the standard treatment plus the new treatment.
The other group is known as the control group, gets the standard treatment only and a placebo (treatment that is identical to the new treatment but contains no active ingredients) instead of the new procedure, hence they are not exposed to the new treatment. The selection of which patient will be in the control group and which patient will be in the treatment group is assigned randomly by the computer, and the randomization is required to prevent biases.
These types of studies are usually “blinded,” which means one or more parties involved in the trial do not know which of the patients is in the control group and which of the patients is in the treatment group. Mainly two types of blinded clinical trial types are available; one is the single-blinded where either the researchers nor the patients know which patients are assigned in which treatment. Double-blinded is the one in which neither the patients nor the researchers know which patient has been assigned in which treatment.
The most reliable results come from the clinical trials which are double-blinded, the patients are randomized and having a controlled group, which is known as the “double-blinded, randomized controlled clinical trial.”
Clinical Trials Phases Updated 2020
There are four different clinical trial phases: phase 1, phase 2, phase 3 and phase 4. if a clinical trial does not have a safe or positive outcome then the trial does not proceed to the next phase. Before the starting of phase 1, there is phase 0, where the new drug has already been tested on the animal or the volunteered humans.
In clinical trials phase 1, the primary objective is to find the right dose for the patients and see how the treatment affects the body and determine its safety or any significant side effects, which is tested in a small group of participants.
In clinical trials phase 2 the trial is conducted in a larger group of patients and studies how the treatment works for the new drug and continues the safety assessment test on the scale of a larger group of patients.
The clinical trials phase 3 is conducted in an even larger group of participants, this trial is done in a randomized design multicenter trials, of two groups in each center comparing the control group with the treatment group and assess how effective the drug is compared to the substitute treatment already available for that particular disease. If the phase 3 clinical trial is positive, then the drug is approved by the clinical trials and gov. drug administration, and be licensed to be marketed to the general population.
Clinical trials Phase 4 is also known as post-marketing surveillance, which continues to assess the effectiveness, safety, adverse effects, and its optimal usage as long as the drug is marketed.
At the end
Clinical trial plays an important role to make sure the effectiveness and safety of the dugs take by the general population, results from clinical trials can help develop new drugs, the new technology of medications, new diagnostic tools, and new procedures. Clinical trials can also bring about new topics for research which may lead to discoveries over time, and give us a better understanding of the diseases. All the drugs available in the market are the result of patients who volunteered to go through the clinical trials.