Clinical Trials

Clinical Trials

Clinical trials are research studies that explore whether a medical strategy, treatment or therapy is safe and effective for humans. Each trial has a focused unique purpose. They are sponsored by groups and/or governmental agencies that bring researchers, scientists and patients together to find an improved drug, treatment or therapy for incurable diseases. They strive for new research that involves new drugs, treatments and therapies or an improvement of existing drugs, treatments and therapies. In relation to mesothelioma, there are a number of clinical trials underway in search of a drug and/or treatment to cure and/or screen mesothelioma. The U. S. has the highest number of clinical trials being conducted in relation to mesothelioma in the world.

The trials make doctors measure effectiveness of the newest drugs and the newest procedures available. They also give a clearer picture on the drugs’ and/or procedures’ ability to produce results. Clinical trials can last for weeks, months or years depending on the desired outcome or goal and whether the treatment needs additional testing to reach the market.

In most cases drugs or medicine require more than one trial to determine their efficacy. Each trial requires extensive planning, funding and accurate execution. Strict federal and industrial guidelines dictate that clinical trials be conducted in safe, regulated facilities.

Phases of Clinical Trials

There are three categories in clinical trials:

1. Prevention,
2. Screening, and
3. Treatment

These categories are dependent on the focus of the trials.

Each clinical trial has three phases in the trial process. If a drug or therapy or treatment passes these three phases it will be well on its way to the Food and Drug Administration (FDA) approval process.

Phase I

Phase I of clinical trials involves a group of twenty or more people. This phase analyses the safety of a drug or therapy. The goal of this phase is to analyze side effects and examine how the drug is processed by the body. This phase also looks at safe dosage levels.

Phase II

Phase II involves three hundred or more patients. This phase takes a closer look at the safety levels and conducts an analysis of how effective the drug or treatment really is. The drug or treatment may be compared with other treatment options or even a placebo.

Phase III

Phase III involves the largest group of several thousand people. This phase measures the effectiveness of the new treatment versus the standard treatment approaches. This phase is used to finalize dosage amounts and document all side effects.