Helping You Understand Clinical Trials

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When manufacturers come up with a new prescription drug that they want to place on the markets, they have many ideas in mind. Perhaps they have the idea that this new drug could be the life-saving, life changing drug that everyone has been hoping for, thinking that it will change the lives of many in ways they never expected. However, before a drug makes it to the markets, it of course must be tested out. This is sometimes a touchy subject because people wonder how a drug can successfully be tested without hurting anybody. A clinical study is a way for a manufacturer to explore whether a certain drug is safe and effective for humans. But how does a clinical study work?

Giving Consent to the Study

Because risks and, sometimes even dangers, are prevalent in medical research studies, it is important to go over matters of consent. Many people who are looking for treatment are doing so because there is nothing else on the market that is helping them and their symptoms when they suffer from a disease, which is why these studies are like a last resort to someone who is struggling on a daily basis. This doesn’t mean that they don’t have a choice. Clinical trials always require consent, no matter what. In a case of clinical drug development where people could be putting their lives on the line, they must undergo informed consent to the manufacturers, as this is listed in the American Psychological Association’s Ethical Code. And if researchers want to test on a child, they are legally required to obtain consent from the parent or guardian of the child before they move forward.

How Clinical Drug Development Trials Work

In Phase 1 clinical trial, researchers test the drug on a small group of people for the first time, and will determine if it has any side effects. In Phase II, a larger group of people accept the drug and determine if it is still considered effective, now that it has been given to more people. In Phase III, large groups of people will monitor side effects as well as compare it with treatments on the market and collect information on how the drug can be used safely on patients in the future. By Phase IV, the clinical team working on the clinical study will submit a New Drug Application (NDA) for approval to put the drug on the market, as it was deemed successful in the trial. Not many will make it to this stage.

Many people participate in these trials every year, because new drugs are constantly being developed for certain conditions. Companies are always looking for the best choice, especially for those who have no other options.

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June 2024
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