Clinical Trials Are Essential In The Pharmaceutical Drug Industry
Nothing happens overnight, especially not in the health industry. Experts spend years and years researching and experimenting formulas to create a drug that can help patients get rid of their pain. There are a lot of tests that a drug undergoes in order to reach the shelves for sale. Companies are not permitted by the government to sell their drug immediately to the consumers without proving its safety and efficiency.
In the medical field, no equipment or drug launches in the market without going through a clinical trial. There are a lot of tests that a drug has to pass and fall in the standards set by the government in order to make their way to the shelf. Clinical trials are basically conducted to collect data portraying safety and efficacy of the pharmaceutical drug or equipment. Once these precautionary steps are taken, the pharma wholesale distributors come into picture.
A clinical trial consists of several stages of approval through which every pharmaceutical drug or equipment needs to pass, to reach the consumers in the market. An extensive laboratory research is conducted to test pharmaceutical devices and drugs.
Certain cells are observed for months to know how they react to a specific drug, to monitor whether it is positive or negative reaction. If it doesn’t work, then what is the possible reason behind the failure? Experts figure out the element that is failing, fix it and then send it back to the laboratory for tests. They are sent back on trial to see whether they are perform well.
Once the laboratory research is successful, the researchers then send the final data to the Food and Drug Administration (FDA) or other official boards. After the approval of the data, the company can conduct all future testing effectively. The testing of pharmaceutical drugs and equipment is typically conducted by the experts in four phases.
Each of the phases are considered as separate trials and after completion of every phase, the investigator is asked to submit a report. Once the FDA approves the report, the company can go ahead with the clinical trials. The following are the four phases of clinical trial:
Phase I: In this phase, the expert assesses the safety of the pharmaceutical equipment, drug or device. In the first phase of testing, experts take several months to complete the testing. The trial is done on few healthy volunteers, they are in between 20 to 100 in number. Each of the volunteers are paid to be a part of the trial.
The study is conducted with a purpose to determine the type of effects the pharmaceutical drugs and equipment have on the human life. The report consists of sections wherein the expert mentions points on how the drug is absorbed, metabolised, and eliminated by the volunteers.
The report also has a section of side effects which the observers have to cover, if they find something unusual happening. They also estimate the effects of high dosage of the medicine. Around 70% of the pharmaceutical drugs pass the first phase of clinical testing. The clinical trials are essential, since only the best should reach the pharma wholesale distributors.
Phase II: In the second phase of the clinical trial, the experts aim to test the efficacy of a pharmaceutical drug or equipment. The second phase of testing can last several months to about two years. The testing involves the participation of hundreds of patients. In the second phase trial, the people are divided into two groups wherein one group is given the new drug while the others receive standard drugs.
This helps the experts differentiate between the standard and the advanced drug. This type of tests allow investigators to come up with reports that show a comparative data analysis. The complete data sheet helps prove the relative safety and level of effectiveness of the new drug. Around one-third of pharmaceutical drugs or equipment successfully complete two phases.
Phase III: In the third phase, clinical trials involve randomised and blind tests. Phase three involves large-scale testing, which usually lasts for several years, providing the pharmaceutical company a detailed sheet of the effectiveness of the pharmaceutical drug or equipment.
Experts also mention the benefits and the kind of possible side effects. 70% to 90% of pharmaceutical drugs or equipment that make their way till this stage, can pass the 3rd phase easily. Once the drug passes the third phase, it can request FDA to give a green signal to market the drug.
Phase IV: In the fourth phase, the expert design objectives that they need to achieve. This phase is popularly known as the post-marketing surveillance trial. This clinical trial phase is conducted after a pharmaceutical drug or equipment is approved by the FDA for consumer sale. Experts of the pharmaceutical companies have the following 3 objectives that they plan to achieve in the fourth phase:
(1) To compare the new pharmaceutical drug or equipment with other drugs or pharmaceutical equipment that are already sold in the market.
(2) To accurately monitor the new pharmaceutical drug’s long-term effectiveness and study the impact of the drug on the patient’s life. Did the drug increase the quality of the patient’s life?
(3) To estimate the cost-effectiveness of the new pharmaceutical drug therapy in relation to the ones that are traditionally used by the experts in the market.
If the company is not able to prove themselves in the fourth phase, then FDA can pass a document stating immediate stop of selling of the pharmaceutical drug or equipment. The study needs to be up-to-date for the FDA to approve the drug’s further distribution.
These are the four phases of the human clinical trial that every drug goes through before reaching the pharmacies for sale. There are a lot of fraud pharmaceutical companies that make counterfeit or duplicate medicines to just attract people by their low prices. Most pharma wholesale distributors in India are aware of these frauds, so they only buy from reputed companies who promise safety of the drugs.
They look at the license of the manufacturer before making a deal with them for the required pharmaceutical drugs or equipment. Some of them also pay a visit at the pharmaceutical drug manufacturer’s factory to see whether they are maintaining hygiene or not. Once they are aware of the actual scenario, distributors then talk business or else reject them right away.
Have you imagined how dangerous would it be if all the pharmaceutical drug manufacturers were allowed to market their drugs without clinical trials? Some manufacturers still sell counterfeit drugs by fooling certain pharma wholesale distributors. Here are some important reasons why clinical trials are important in the pharmaceutical drug industry:
1. It helps the expert understand the exact effect of the drug on the disorder or disease.
2. Experts can determine the chances of side effects.
3. Experimenting the drug on different sex and age groups give an idea of its efficiency.
4. Clinical trials also help experts understand the worse case scenario of over-dosage. They can get answers to questions such as how will a human cell react to over-dosage of a certain pharmaceutical drug?
5. The government will get the surety of the safety of its citizen by testing the drug in all temperatures and critically evaluating it before allowing it in the market.
6. Experts will be able to figure out what other diseases the drug can fight. Are there any more advantages to it which a consumer can benefit from?
Now that you are aware of the reasons why human clinical trials are important in a pharmaceutical drug industry, there is something more important that you should be aware of while buying your drugs.
Always buy drugs from a reputed and authentic pharma wholesale distributor who is ready to show you all the necessary paperwork, license and provide quality medicines at a reasonable price. If you are a hospital, a clinic or a pharmacy, you have to remember that you will be equally responsible for any negligence or pain caused to people. Because of the carelessness and negligence during the purchase of drugs from an unauthorised distributor, Patients end up bearing the brunt of low-quality medicines or equipment.
Make sure to check their license, research about their company online, talk to some of the companies they are supplying drugs to, and discuss your requirement before signing a deal. This will give you the certainty about the quality of the pharmaceutical drugs or equipment. You will need to protect your patients, therefore, take every possible chance to only get drugs and equipment that can help the masses to a great extent!