Participating in a Clinical Research Trial

Some women with advanced breast cancer may want to consider clinical trials as a treatment option. Clinical trials are a type of medical research in which new treatments are studied in groups of patients. Through the clinical trial process, new treatments can be tested to find more effective treatments, to increase survival time, and increase the quality of life for women with advanced breast cancer.¹ Clinical trials can offer a potential additional treatment option and hope to certain patients, especially those for whom standard therapies have not worked.

Phases of clinical trials

There are different types of trials: observational or interventional. Observational clinical trials also referred to as epidemiological studies, observe the participants and monitor their health over a set period of time. They may also be retrospective (looking at past patient data). No trial drugs or treatments are given to participants in an observational trial. These trials help researchers understand how a disease progresses and provides information that can help them determine how best to treat it. Interventional clinical trials test a new drug, therapy, or experimental treatment. Interventional trials are designed to assess the new treatment’s safety and effectiveness.²

Prior to clinical trials, drugs must go through stringent laboratory testing. If a particular medication is found to work in the laboratory, it then must go through four different stages of clinical trials:

• Phase I: the researchers test a new drug on a small group of people (10-80) to evaluate its safety, determine a safe dose, and evaluate any potential side effects
• Phase II: a larger group of people (100-300) are given the drug to determine its effectiveness and further evaluate safety
• Phase III: the drug is given to large numbers of people (1,000-3,000) to confirm its effectiveness, evaluate side effects, compare it to existing treatments, and identify any additional information about how to use the drug safely
• Phase IV: additional studies done after the drug is approved by the U.S. Food and Drug Administration (FDA), and is available in the market, to gather information on long-term use³

The challenges of clinical trials

The clinical trial process is long and expensive – it takes many years for a product to go through all the necessary phases, and many potential treatments fail to show effectiveness to move to the next phase. In addition, approximately 20% of cancer trials fail because they do not have enough participants. Regulatory agencies like the FDA require large groups of participants in trials to ensure the safety and effectiveness of therapies before they are brought to market.⁴

Volunteering for clinical trials

Researchers have demonstrated that patients who enroll in clinical trials often fare better than patients who do not participate.⁴ In addition to the potential for receiving the latest treatment innovations, this benefit could be due to the close monitoring of patients in clinical trials by healthcare professionals.

Before taking part in a clinical trial, patients are provided with an informed consent form, which includes important information about the trial, including its purpose, how long it is expected to last, any tests or procedures that are expected, and potential benefits and risks (like side effects). The informed consent form must be signed before taking part in a research trial. Signing the informed consent form confirms that the patient has been given and understands the information contained in it. In addition, informed consent continues throughout the research trial, as new information about the treatment becomes available. Patients always have the right to leave a trial at any time.^1,5

While an individual may have their condition improved by participating in a clinical trial, there is also a chance that there will not be any benefit, and the individual may be exposed to unplanned risks or side effects. Informed consent aims to give the patient all the information needed to make a decision about participating in the research trial.⁵