Information On Clinical Trials

Every single year there are clinical trials that occur across the nation that work with products and items from a number of different companies. These clinical trials are more important than most imagine because in order to be approved for safe use they have to pass the trial. If they do not pass, then the company that has created this product must revise it and make changes as well.

The average person will most likely know little to nothing about how these clinical trials work unless they have been involved in one themselves. These trials have been around for quite some time and can last for over a year. As a matter of fact, in the year 1999, one trial managed to last over 460 days, and in 2005 a trial took place that lasted nearly 780 days. Here are all of the facts about a phase 1 clinical trial.

A phase 1 clinical trial is just the beginning steps in a clinical trial. Keep in mind that there are multiple phases of a clinical trial that act as steps. When conducting a clinical trial, those who are responsible will start at phase 1 and they will then work through each phase. The real difference between these trials deals specifically with the number of people involved in the testing of the drug or treatment.

If you are someone who worries that a phase 1 clinical trial sounds dangerous, you should not worry at all. The proper steps are taken to ensure that a phase 1 clinical trial is incredibly safe for the people involved. Whenever researchers are planning on using a child under the age of 18 in a study, they have to get consent from a parent or guardian of said child.

Furthermore, the American Psychological Association’s Ethical Code has created a section just for informed consent. Informed consent is important because it works to help protect the people who are involved in the study. It requires that the researchers conducting the phase 1 clinical trial must inform the testees of all aspects of phase 1 clinical trial.

Medical research studies for clinical drug development is important and the public seems to agree according to recent studies. A recent study was conducted in which respondents are asked if they believe that the phase 1 clinical trial is important. Just about 46% of all people somewhat agree that taking part in phase 1 clinical trial is just as valuable to the health care system as giving blood.

A clinical study will get their phase number depending on the number of people involved in this study. In phase 1 clinical trial, researchers will test a drug or treatment on a small group of people for the first time. The number of people will be between 20 and 80 and they will test this drug for safety and to identify side effects.

Within Phase II trials, the experimental drug or treatment will be given to a larger group of people. This larger group of people will consist of anywhere between 100 to 300. This trial is done to specifically determine the effectiveness and to also further help evaluate the safety of the said drug.

The next step is the Phase III trial in which the drug or treatment is then given to an even larger group of people. This group of people will consist of anywhere between 1,000 and 3,000 people. This trial aims to specifically monitor side effects, compare it with standard or equivalent treatments, confirm the effectiveness of the drug, and to also collect information that can allow for the drug to be used safely.

In Conclusion

Clinical trials are absolutely essential for the success of the health care system within the United States. These trials help drug companies ensure that the drugs and treatments they are using are safe and healthy. This is done so that people can get the right kind of help that they need without suffering from dangerous or unpredictable side effects.