Are Clinical Trials an Option for You?

Cancer research is a very important step in helping us find a cure for cancer. One form of this research comes from conducting clinical trials, which are cancer research studies to determine if, or how well, a particular cancer treatment works.

These studies also help to determine what types of side effects may occur from a particular cancer treatment. Clinical trials involve cancer patients taking new cancer treatment drugs before these drugs are approved by the FDA

In order for a patient to participate in a clinical trial, they must sign a consent form to be tested with a particular drug, as it is not known if this drug treatment will work, or how safe it is to take. That’s the basis of why a clinical trial is undertaken and why patients must provide their consent to be tested.

Clinical Trial Phases
There are different phases of a clinical trial to help determine the treatment drug dose, safety and its effectiveness.

The treatment within clinical trials can involve a new cancer drug by itself or a standard cancer treatment that includes a new cancer drug. When a clinical trial involves a new drug by itself, this is referred to as a phase 1 or phase 2 study.

When a trial is administered with an already approved cancer treatment that is combined with a clinical trial drug this is called a phase 3 study.

Phase 1 studies focus more on treatment side effects and treatment safety than treatment effectiveness. Phase 2 and Phase 3 studies focus more on the effectiveness of the cancer treatment, rather than on side effects.

Phase 2 clinical trials provide additional evidence of biological effects against certain types of cancers and phase 3 trials provide the most definitive evidence for whether a cancer drug or treatment is effective.

Some studies may be randomized clinical trials, so the patient will not get to choose whether they will receive the new cancer treatment drug. Instead, this will be determined by chance, much like the flip of the coin. Other clinical studies are referred to as blinded, which means the patient, and sometimes the doctor, will not know if the new study drug will be administered.

When it comes to cancer research, not all clinical trials will study a cancer treatment. Some trials may also seek for new ways to diagnose, detect or learn more about a particular cancer. Other trials may even study the ways of preventing a cancer from occurring altogether. And some studies may even involve a drug treatment that is already approved by the FDA so that the treatment may be studied on other types of cancer.

For clinical trials that do pertain to the study of cancer treatments, not all of these may involve research on a new cancer drug either, as there are also many clinical trials that test other options of cancer treatment, such as new radiation therapy or surgery techniques.

Patients may remove themselves from a clinical trial at any time. And sometimes the doctor my remove a patient from the study if serious side effects from the treatment occur.

Paying for Clinical Trials
If you are considering getting involved in a clinical trial, there are two types of costs associated with the trial: patient care costs and research costs.

Patient care costs are usually covered by health insurance and may include visits to the doctor, lab tests, X-rays or other diagnostic and imaging tests, as well as possible hospital stays.

Research costs are associated directly with the participation in the trial. While these costs are not covered by health insurance, they may still be covered by the trial’s sponsor. Costs associated with the research may include the actual study drug, any lab tests performed for research purposes and any additional x-rays, diagnostic or imaging tests that are required solely for the trial.

Additionally, while the patient may not be required to pay any more out of pocket costs, their involvement in a trial may include extra doctor visits and more tests, which would not have occurred with a standard cancer treatment.

Benefit and Risks
When you need treatment for cancer, you may consider participating in a clinical trial. Just like all cancer treatments, clinical trials may offer possible benefits and also include risks.

Possible benefits from a clinical trial may include the following:

  • Receiving a new cancer treatment that is not available to people outside the trial.
    Having a research team watching you and overseeing the treatment closely.

  • You may be the first to benefit from a new treatment should the treatment studied prove to be more effective than the standard cancer treatment.

  • You may be helping future cancer patients, as the trail may help scientists learn more about cancer.

There may also be possible risks associated with a trial study.

  • The new treatment may not be better, or as good, as the standard treatment.Having a research team watching you and overseeing the treatment closely.

  • A new treatment may create side effects that the doctors did not expect or lead to side effects that are more severe than those from a standard treatment.

  • You may be required to make more visits to the doctor than if you were receiving a standard treatment.

  • Extra testing may be required; some of these tests could be more time consuming.

  • Even if the new treatment offers benefits to some patients, the treatment may not work for you.
    Health insurance may not cover all patient care costs in a trial.

Who is Eligible to Join a Clinical Trial?
Each clinical trial will have a study plan that will describe what will take place during the trial, how the trial will be conducted and why each part of the trial is necessary. The trial’s study plan will include guidelines as to who may be eligible to participate in the trial. While patients may volunteer to be a part of a trial they must also meet the eligibility requirements of the clinical trial. This criteria is referred to as eligibility criteria.

Eligibility Criteria May Include:

  • Having a certain stage and cancer type.

  • Having either received, or not, a certain type of previous treatment or therapy.

  • Being within a certain age group.
    The patient’s medical history.

  • Existing health status.

Such criteria will help reduce any medical differences among people tested in a trial. The more alike people are to each other in key ways within a trial, the more certain researchers can be of the results being attributed to the treatment tested and not to any other factors.

Another consideration of participating in a trial is that some people may have health problems, other than their cancer, that could be made worse by the trial treatments. If you are interested in joining a trial, you will receive medical tests to be verify that you are fit for the trial.

Finding a Clinical Trial
A good first step is to talk with your doctor to discuss whether a trial is an option or a possibility. Also, because new cancer research is constantly evolving, there are many new clinical trials that are continuously being created. For this reason, many people also look in other places to find research studies that may pertain to them.

Here are a few of the organizations that offer free, searchable listings of cancer clinical trials:

CenterWatch – This publishing and information services company offers a list of institutional review board (IRB) approved clinical trials.

National Cancer Institute (NCI) Clinical Trials– The NCI is part of the National Institute of Health and is a federal agency that provides funding for most cancer clinical trials in the United Sates. – This is a not-for-profit online service that helps users locate clinical trials that are specific to breast cancer.

Understanding what clinical trials are can help you decide if participating in a trial might be an option for you, or if you have a family member or friend with cancer and are just trying to determine if a clinical trial is something they should consider.

Clinical trials are essential to finding a cure for cancer. They help bring new methods of preventing, diagnosing and treating cancer from the laboratory to the doctors’ offices. The cancer community appreciates all of the patients who have participated or who are currently participating in clinical trials.

Learn more about Clinical Trials with Oncology Associates.