Health Care

By Laura Guthrie

For many people the very word cancer conjures up images of an incurable disease, possibly one that is terminal. Worse still it is commonly believed that many of the treatments for cancer are almost as bad as the disease itself. The most often applied medical interventions include medications, chemotherapy, radiation treatments and surgeries. While cancer is nothing that any of us wish to have to face it is important to know that there are many treatment options available and that at any time there are also a significant number of clinical trials that are going on that are working on developing promising new treatments for the disease.

When medications or other treatments are developed there is a long process before the Food and Drug Administration (FDA) releases the treatment or drug to the general public. Strict laws govern the testing and development phases to insure the safety of the consumer. Before any new medication or medical technique can be tested on humans in clinical research trials it will first be tested on animals and with other lab techniques. These techniques can include in-vitro and tissue testing, among other methods. Many potential treatments never make it past this stage for a variety of reasons.

Those that do, however, will be slated for a clinical research trial. Clinical research trials involve human participants who are willing to be given an experimental treatment. The hope is that not only will the trial participants benefit from this treatment but that it will be successful and consequently benefit untold numbers of other patients in the future. There are three different phases of clinical research testing.

In Phase 1 the new drug is administered to a very small number of people in order to assess the safety of the drug in humans. Side effects will also be noted. The 70% of drugs that pass this phase move onto Phase 2.

Phase 2 studies will test for the effectiveness of the medication in treating what it is designed to treat. In these studies generally a portion of the participants will be given the real drug while the rest receive a placebo. Only about 1/3 of drugs make it through this phase of testing.

Phase 3 testing involves a much larger group of patients and continues testing for safety, side effects and effectiveness of the medication. This phase of testing often lasts for many years. If a drug successfully passes through these three stages a pharmaceutical company may then apply to the Food and Drug Administration for approval. Clinical trials can be a wonderful opportunity for patients to get innovative new treatments that might not otherwise be available. However one must weigh the potential benefits against the risks.

First of all patients participating in a Phase 2 study are not guaranteed to even receive the medication but may be part of the placebo group. In this case, they will not benefit from the trial, except through knowing that they are helping to get a new treatment out to others who may benefit from it. Additionally, because these medications have not yet been approved by the FDA there is, of course, a risk of side effects.

These side effects may not show up immediately as it is often years after a drug is released into the market before some of them are seen. For cancer patients for whom currently available treatments are not working, however, a clinical trial may offer a better chance of recovery.