A pharmaceutical clinical trial is the highlight of the global medicine industry. These trials are the most crucial process we can say, because they evaluate the efficacy, safety and necessity of a particular drug.
Considering the rapid rate at which the world is falling prey to health problems, we now take an even more vested interest in these studies. It wouldn’t be wrong to define them as a necessary tool for achieving approval of the relevant authorities before pharmaceutical companies make their drugs available to patients.
Clinical trials are important because only through them can the medicine industry discover new and advanced treatment procedures, diagnostic approaches medicinal cures and ways of decreasing the development of a host of sicknesses.
For researchers, these studies are the only way to discover what would work or not work on human patients. Clinical trials are the most important aspect of any pharmaceutical company but the choice of participating in them is completely left to the discretion of volunteers.
But what does the journey of from drug concept to drug approval entail? Let’s find that out below:
To put simply, clinical trials are length research studies on human subjects to test new drugs, new therapies, new diagnostic procedures, new treatment equipment and vaccines. These length periods of study assess how a new drugs and new treatment procedures perform and how safe they are for use.
The more meticulous a clinical trial is, the faster and safer the approach will be in finding medicines and treatments that help patients.
Every clinical trial first begins with a concept of a new therapy or procedure. To test the weight of the idea, researchers conduct investigational processes in laboratories and on animal subjects. Then only those treatments and medicines that show promising possibilities move to human clinical trials.
Every pharmaceutical clinical trial has to pass through four phases. During each trial, researchers uncovering more and more information regarding the theory under test, its safety and risk factors, chances of success and its impact on the quality of life.
The four phases of pharmaceutical clinical trials are as follows:
This phase features a smaller number of volunteer participants, who can be either very healthy or those that have no other treatment options. In this phase, the concerned doctors and scientists have the opportunity of exploring their medical theory at detail and how the investigational compound would affect its recipients.
The simple goal of this phase is to study the tolerability and safety of humans when they have consumed the new drug in any way. The team of expert working on the clinical trial then close monitor and observe their subjects for signs of side effects or severity that the compound may produce.
After the first phase has confirmed the safety of a new drug or treatment for human use, the second phase begins. In this phase, the researchers involve a larger group of volunteers to further test the efficacy, safety and impact of the new concept.
They administer the investigational medicine in different doses to monitor its side effect at every stage. Generally, in this phase the team divides their entire group of volunteers (from 30 to 300) in categories and gives them different dosages to compare the effects and safety.
It is not uncommon for the second phase to run across a variety of indications or patient populations for testing the new drug.
This phase too studies the efficacy and safety of a medicine product, over a large number of volunteers. In this stage, the clinical experts can confirm the safety, benefits and risks adequately of their investigational drug.
The other important step that occurs in this clinical trial phase is the testing of the new drug in combination with other treatments and therapies. This phase provides vital information on how well the new drug will correspond with the other treatment and therapies or counteract.
Based on what the conclusive evidence of this phase is, the teams deduce how best to prescribe this compound to patients in future.
By this stage, the research team of medical experts can somewhat take a sigh of relief because they have earned the regulatory approval. When the regulatory authority has shown the green light for the new drug or treatment, it means that pharmaceutical companies can gear into action and start planning the launch of their new product.
The fourth clinical trial phase continues after regulatory authorities have allowed the distribution of a drug based on successful evidence. Surveillance trial post-marketing begins in this phase, in which drug companies continue to monitor the effects, safety and success of a drug when the masses start using it.
It gives them insight into the long terms benefits and risks of the drug over a diverse population of patients. The regulatory authorities or investors of the new drug can often ask for the fourth clinical trial jut for further evidence of the performance of a drug.
During pharmaceutical clinical trials, the most essential requirements to conduct studies are the presence of a host of clinical supplies. These include a wide variety of materials that the investigative teams and participants will be using during the course of the trials.
Clinical supply services work round the clock to collect and deliver biological specimens, such as infectious samples and others, kits, study supplies and materials, investigative drugs, necessary equipment and lots more.
According to the American Cancer Society, about a thousand potential medicines undergo years and years of clinical trials before the regulatory authorities approve of one from those. The point is that pharmaceutical clinical trials are the most essential process in the medicine industry because they determine the efficacy, safety, benefits and risks of a potential drug or treatment method.
When the lives of millions of people are at stake, it places great responsibility upon the regulatory authorities to only approve those drugs, which prove through rigorous testing that they will be beneficial in treating a disease. Hence, this is why pharmaceutical clinical trials can often run over a span of six to seven years at an average.