A clinical trial is an experimental study program which is performed by medical researchers for the purpose of testing new drugs, treatments, diagnosing techniques, and other unproven medical techniques. Cancer clinical trials are an important part of cancer research in medicine today. Patients are able to volunteer to test out new experimental drugs that have not yet been approved for widespread use if they have no other treatment options to turn to. Patients also participate in cancer clinical trials to help advance cancer treatment with the ultimate goal of finding a cure. In most cases, patients undergoing a clinical trial will likely have an advanced form of cancer that may be difficult to treat by conventional treatments, such as surgery, radiation therapy, and chemotherapy.

Clinical trials attempt to answer two fundamental questions for cancer treatment--(1) does the drug work against tumors and (2) is the treatment safe to use? If the treatment shows promising results, followup questions about the treatment are asked. Is the treatment more effective than conventional cancer treatments? If not, is it just as effective? If so, does it produce fewer side effects? Also, does it work more effectively for certain people than others? If the answers to these questions point to "yes," then the treatment in question moves to advanced phases of research.

Qualifying for a Clinical Trial

Cancer clinical trials generally require that patients meet certain criteria before being approved to participate. This is because some clinical trials are designed to target patients with certain characteristics. This can include age, the type of cancer, the stage of the cancer, or gender. Most cancer clinical trials will lay down both inclusion and exclusion criteria. Inclusion criteria outlines which characteristics a patient should have to be approved for study. Exclusion criteria is criteria that would disqualify a patient. A patient may have expanded access if he or she has no other treatment options to turn to and would benefit from a cancer clinical trial.

Risks and Benefits of Participating in a Clinical Trial

There are many reasons for a patient to choose to participate in a clinical trials and there are also many reasons not to do so. Before making a decision, a cancer patient should understand the benefits and risks involved with trials. Though clinical trials help advance cancer research, there may be other options that would provide more effective help for his or her particular situation. So what are some risks and benefits of choosing to sign up for a cancer clinical trial?

Benefits:

People with advanced forms of cancer may have no other option to turn to and their best option would be to enter into a clinical trial.

Clinical trials help to provide hope to patients who have an advanced cancer.

A person may want to help contribute to the greater cause of cancer research.

Risks:

When a patient enters a clinical trial, he or she may not receive the experimental treatment.

Drugs used in trials are unproven and a patient may not benefit from the experimental nature of the drugs.

Though some clinical trial treatments work, they may not be as effective as already approved treatments.

Phases of a Clinical Trial

Each phase of the clinical trial is designed to give new pieces of information to researchers. They are designed to provide the utmost safety to patients who have qualified and chosen to partake in the clinical trials.

Phase 0:

A very small amount of the experimental drug is given to patients to test its interaction with the human body. This is considered to be strictly a safety test for the drug.

Phase I:

A small dose is given to patients with the intent of destroying tumor cells. The main purpose of this phase is to determine what is the proper doses of a type of experimental drug.

Phase II:

The main goal of this phase is to gain a better understanding of the drug's effectiveness and to decide if it is an effective drug treatment option for use against tumors. By this phase, the drug is considered to be safe to be given to humans.

Phase III:

By this phase, a drug is considered to be effective against tumor cells, though the experimental drugs are compared to already existing drugs that are used commonly to treat cancer.

Phase IV:

The final stage of the clinical trial which is primarily used to test the drug for long-term side effects.