Why Do We Need Worldwide Clinical Trial?
Clinical Trial is one of the most important parts of drug industry. No drug can be introduced to the market till the time it doesn’t has successful clinical trial. A proper clinical trial protocol has to be followed in order to make sure, that the medicine is safe for the patients.
There are different phases of clinical trials which needs to be performed in order to get the approval from FDA.
Finding and appropriate dosage and looking for side effects is the ultimate aim of the having a clinical trial. Once the initial three phases are tested and examined by the researchers and certified as safe and effective, that is where FDA comes in and approve the drug and further monitoring of its effects can be done.
Phases of Clinical Trial!
There are four phases of clinical trial; all these steps describe what clinical trial the drug is in. In order to get and monitoring approval from FDA any drug has to pass phase one, two and three.
Phase One Trial:
- This phase of clinical trial is used in order to see how safe the drug is, it is there in order to judge the side effects and the dosage of the drug
- It is often used on a small group of people of 20-80 people.
Phase Two Trials:
- It is used on more than 100-300 in order to get better results.
- The main focus is to find the effectiveness of the drug
- This phase of clinical trial focuses on getting the complete data on whether the drug is effective on certain conditions or diseases
- It also focuses on safety and short term side-effects
- This phase often last for several years
Phase Three Trials:
- This phase of clinical trial is completely focused on gathering more information on effectiveness and safety of the drug
- In this phase different dosage is used in different populations for more authentic results
- The drug is also test along with other drugs, in order to find If there are any resistance
- The range may go up to 3000 people
- Usually if the drug is approved by FDA it is then promoted for further development.
Phase Four Trials:
- In this phase of clinical trial the drug is tested on large, diverse populations in order to check all possible outcomes.
- It takes years to finally check all possible conditions and side effects of the drug.
- Once everything is over that’s when the drug is released in the market
Why Would People Participate in Clinical Trial?
There are multiple reasons for people to volunteer for clinical trials. Few people would join to find out a cure for the health problems they have already had many treatments for but couldn’t get any better. Few may volunteer for free treatment as there is no treatment for their problem. Few may join in to find out a cure for a problem which may run in their family. This is a good way to access more treatments before the treatment is in the market.
Many people share that that by participating in clinical trial there being more active for their health, some say that would love to help researcher in order to learn health problem. Some say this gives them a new hope, few say this gives them a satisfaction about saving someone. Whatever the motivation would be every single one of the participants has contributed a lot in order to have medical breakthroughs, this small contribution will help future generations.
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