Clinical Trials

Promising new drugs must be extensively tested to make sure they are safe and effective before the Federal Drug Administration (FDA) can approve them for use in patients.   To learn all the potential side effects, the most effective dosages and how effective a new drug is against a specific disease requires testing in humans.   For safety, the FDA has developed a system of clinical trials to provide data on medications that promise new & better treatments of illness.

Before a new drug can even be considered for experimental use in humans, it must undergo exhaustive testing in animals to make sure there are no serious dangers involved.  Patients can benefit from participating in clinical trials by getting newer and more powerful treatments.

There are various types of clinical trials. A basic understanding of the clinical trials system can help patients learn the risks and benefits of participating in various clinical trials. In cases where established treatments have been exhausted, an investigational treatment may offer new hope for serious illness like cancer. 

Phase I trials: the first step in testing a new drug or treatment for approval. Since the effects in humans are not fully known, researchers keep the study group as small as possible. The study size may range from 20 to 80 participants.  The goals of this stage are to evaluate the safety of the drug and learn what side effects may occur. A dosage range that is safe and effective is also determined.

Phase II trials: is the next step in gaining approval of a new drug. Once the safety has been established in Phase I trials, the experimental drug or treatment can be used in a larger test group to see how effective it is against a singles illness or a group of diseases.  Phase II trials employ a larger test group of up to 300 participants. The goals are to learn if the drug is effective for a specific application and to further evaluate the drug’s safety.

Phase III trials: is the final step before a drug can be approved. Larger study groups of 1,000 to 3,000 participants enable researchers to collect a bigger database of information about a new drug.   The goals of this step are to confirm a drug’s effectiveness and monitor side effects.  To learn how effective the drug is, these studies usually compare it to an established drug or treatment known to be effective for a specific disease.  This information helps doctors to use the drug in the safest and most effective way.

Phase IV trials: are post-marketing studies that gather information about how an approved drug works against other diseases, and how best to use the drug.
Clinical studies explore more than just new drugs.  Any intervention that could possibly improve health or fight disease needs to be systematically studied in a controlled way.   So medications, surgery, lifestyle changes, medical testing techniques and even alternative therapies are put though rigorous testing to ensure patient safety.

• Treatment
• Prevention
• Diagnostic techniques
• Screening methods
• Quality of Life

To learn more about how participating in clinical trials can impact your treatment, fill out our free info packet request. If you are considering enrolling in a study, discuss the potential benefits and possible risks with your medical team.  If you decide to participate, you’ll not only be helping yourself, but many other people fighting serious illness as well.