Facts On Clinical Drug Development

Clinical study

Since the start of the civilized society we live in now, the medical industry has always been a pillar of the modern day world. Think back to before the practices of modern day medicine and you will understand how far both this country and the entire world has come. Surgeons back in the old days had a hard time even properly doing a routine simply surgery because of germs and the inability to block out bacteria.

Now we live in a world where medicine has the ability to seemingly cure almost everything. Now there are obviously some illnesses that are terminal and cannot be stopped, but even then the medical industry is pushing forward to break down barriers and fix previously fatal illnesses. One of the big pushes comes in the form of clinical drug development.

The process of clinical drug development is complicated for many people and involved clinical study, clinical trials, medical research studies, and a process with three phases that start with a phase 1 clinical trial. Here are the facts on clinical drug development.

A survey was conducted about clinical trials taking place in the United States. 96% of all people involved in the survey said they have never actually participated in a clinical trial. This goes to show the limited amount of knowledge and experience the public has with this sort of information. 46% of all people agree that being involved in a clinical trial is the equivalent of donating blood in terms of helping the health care system. Also know that in 1996, a clinical trial normally lasted about 460 days, but in the year of 2015, it was stretched to 780 days.

There are different phases in clinical drug development, that include Phase I, Phase II, and Phase III. In Phase I trials, a small group of people tests an experimental drug or treatment for the first time to evaluate its safety and to reveal side effects. In Phase II trials, 100 to 300 people are given an experimental drug or treatment to determine its effectiveness and further understand safety.

In Phase III trials, the experimental drug or treatment is given to a group of 1,000 to 3,000 people to confirm how effective it is, any minor side effects, comparisons to normal treatments, all while gathering information to make the drug safe for people to consume. After Phase IV is completed the trial team will ask for approval of the New Drug Application for approval to gon on the market. Only one in every 5,000 to 10,000 drugs actually get approved by the Food and Drug Administration.

In the 9th revision of the American Psychological Association’s Ethical Code, informed consent has its own section in 8.02 because it is viewed to be so important. Any time a child, defined as anyone younger than 18, in a study, they are required to get consent from either a parent or guardian of said child. This is done to help protect young children from being manipulated or pulled into any experiment that they are ignorant of.

In Conclusion

Clinical drug development is incredibly important to the medical industry. It helps to test out new drugs and to help get people the drugs they need while keeping them safe. After all, what help do you get from a drug that brings about side effects that can develop into serious illnesses or will make the situation possibly worse than it is now? This is not to say that everyone should sign up to be a part of the clinical drug development, but to instead help people understand its importance. After all, as mentioned earlier there are a lot of people who view it as equal to giving blood which is a great thing to do.

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