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Why Clinical Trials Are Critical in Drug Development

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Why Clinical Trials Are Critical in Drug Development

Throughout the history of medicine, clinical trials have played a crucial role. They allow scientists to find answers that would otherwise be unobtainable. For instance, is the treatment safe for humans to use? How effective is it? Will users need to watch out for side effects? Without clinical trials, these questions cannot be answered, and scientists will know very little about the treatment. That’s why the clinical trial stage is considered one of the most important stages of drug development.
Why Clinical Trials Are Critical

The Stages of Drug Development

Before a drug is able to make it to the clinical trial stage, it must first pass the preclinical stage. Before it can reach this stage, the company or research institution (whoever is responsible for developing the drug) must submit an application to the Food and Drug Administration. The application will be reviewed.

If the FDA approves the application, the preclinical stage may begin. This step involves testing the drug on animals in a laboratory. The FDA monitors these tests and, based on the results, must declare the treatment safe enough to test on humans.

When the treatment is declared safe enough for clinical trials, a panel of scientists and researchers will determine the test subjects, the procedures they will need to undergo, and how long the study will last. Many research companies, such as quintilesclinicaltrials, will reach out to individuals in the area, offering payment for registration.

Phase 1

The first phase of clinical testing involves isolating common side effects of the treatment. The way the human body processes the drug is also documented.

Why It’s Important

The first phase of clinical testing is crucial because the drug cannot be cleared for human use until its effects are known. Side effects may be potentially deadly. If this is the case, the drug will need to be re-evaluated and reformulated before it can move forward in testing.

By being aware of a treatment’s side effects, researchers and scientists can advise individuals as to whether or not the treatment is right for them. People with certain conditions, for instance, may be unable to handle certain side effects.

Phase 2

Safety is the most important aspect of the trials. That’s why a drug must pass the first phase before it can make it to the second. If it does, the focus shifts away from safety (isolating side effects and their causes) to effectiveness.

Why it’s Important

The second phase reveals the most relevant data—whether or not the drug works on the people who have the condition for which it was developed. Some patients are given the experimental drug, while others may be given a different treatment. The effectiveness is then compared and documented. The experimental drug is also compared with a placebo. This phase is important because it will determine the success of the drug.

Phase 3

If the drug passes through the other two phases, it enters into the third phase. This study involves a larger range of people with a variety of conditions. In this phase, safety and effectiveness of the drug will be monitored further, but with different variables. These variables may include different ages of the test subject, taking the test drug in combination with other drugs, and different dosages.

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