What is a Clinical Trial?

A clinical trial is a type of clinical research that follows a detailed treatment plan or protocol. In addition, the compilation of data gathered from the trial can go on to further science and benefit others.

Cancer Clinical Trial patient in treatment facilityHow Clinical Trials Can Help

The main purpose of clinical trials is to study new treatments such as a new drug, new combinations of treatments or new treatment methods in order to receive government approval. By taking part in a clinical trial, participants have access to new drugs and treatments before they are widely available. Patients that are enrolled on clinical trials have typically completed all standard treatment options and enrolling in a study may offer new treatment alternatives to patients that have otherwise run out of choices.

Clinical Trial Eligibility

All clinical trials have specific eligibility criteria. The criteria are based on factors such as type of disease, age, medical history and current medical condition. Before entering into a clinical trial, you must meet the criteria for the study.

As with any cancer treatment, there may be some unpleasant or serious side effects and there are no guarantees that the treatment will be effective for the person participating. A research representative will discuss the risks and benefits with you and answer any questions you may have prior to you signing a consent form. You are free to discontinue the study at any time.

Phases of Clinical Trials

Clinical trials are conducted in four different phases with each phase serving a specific purpose to researchers.

 

Phase I:

Assess the safety of a new drug. The phase is usually done with a small group of people (20 to 80) and evaluates how the body handles the drug, safe dosage ranges and side effects. 

Phase II:

The drug or treatment is given to a larger group (100 to 300) to determine effectiveness and to continue to evaluate safety

Phase III:

The drug has shown promise in the Phase II study and now hundreds or even thousands of people may receive a new drug or treatment and be followed for several years. This phase helps confirm the effectiveness of the drug, gauge side effects and gather information so the drug or treatment can be used safely. 

Phase IV:

The drug or treatment has received Food and Drug Administration approval and is widely marketed. This allows researchers to gather additional safety information on an even larger group of people and gather data on a drug or treatment's long-term effectiveness and how it affects quality of life. The drug or treatment may also be evaluated for cost and against other similar drugs already on the market.

Paying for Clinical Trials

As you consider taking part in a clinical trial, you will face the issue of how to cover the costs of care. There are two types of costs associated with a clinical trial:  research costs and standard care costs.

Cancer clinical trial patient discussing options with doctor in treatment facility.Research Costs

Research costs are those related to anything that is done solely for the clinical trial. Often these costs are not covered by health insurance, but they may be covered by the trial’s sponsor. Examples include:

  • The study drug
  • Lab tests performed purely for research purposes
  • Additional x-rays and imaging tests performed solely for the trial

When you take part in a trial, you may have extra doctor visits that you would not have with standard treatment. During these visits your doctor carefully watches for side effects and your safety in the study. Feel free to discuss these issues with your research team prior to signing your consent form. 

Standard Care Costs

Patient care costs are those standard costs related to anything that would have been done if you were not in a trial. These costs are often covered by health insurance. They include:

  • Doctor visits
  • Hospital stays
  • Standard cancer treatments
  • Treatments to reduce or eliminate symptoms of cancer or side effects from treatment
  • Lab tests
  • X-rays and other imaging tests

For instance, if you are being treated with a standard drug regimen plus a study drug, your insurance should cover the standard drug regimen and the study sponsor should cover the study drug.  Feel free to discuss these issues with your research team prior to signing your consent form.