By Leslie Verner, Certified Breast Cancer Nurse
Mission Cancer Program
Mission Hospital’s Cancer Program is proud to offer clinical trials to our breast cancer patients. But what exactly is a clinical trial? What are the benefits? How do patients decide if they are right for them? Let’s address these common questions.
What are clinical trials?
These trials are sponsored by the National Cancer Institute and various pharmaceutical companies. They explore cutting-edge treatments that may change the way breast cancer is treated in the future. In most studies, clinical trials compare a new treatment to standard-of-care treatments that are already approved by the FDA to determine whether the new treatment offers a benefit over the standard-of-care treatment alone.
Each clinical trial is led by a principle investigator and involves a team of doctors, nurses and other healthcare professionals who are experts in their field. These research studies can be conducted in various locations such as hospitals, universities, doctors’ offices or community clinics. The purpose of offering clinical trials is to add to the medical knowledge related to the treatment, diagnosis and prevention of diseases such as breast cancer. Clinical trials help to answer specific treatment-related research questions, while ensuring the patient’s safety at the same time.
Who is eligible for clinical trials?
Each protocol or clinical trial has specific eligibility criteria that must be met in order for a patient to participate in the trial. If eligible, a patient will then meet with the research nurse coordinating the trial and go through a detailed informed-consent process. The purpose of the informed consent is to protect the patient by providing them with information about the purpose, risks and potential benefits of the study, so that they can make an “informed” consent. Patients are also informed that they can withdraw from the study at any point, even after signing the consent form.
When a patient participates in a clinical trial, they may or may not receive direct benefit from the trial. Their participation, however, will contribute to medical knowledge and may make a difference in how future patients are treated. Patients on a clinical trial will always receive the standard of care for their disease. In addition to that, they may also receive an investigational agent.
What are the benefits of clinical trials?
There are many benefits to participating in clinical trials and also some risks:
- Patients participating in research studies may have access to investigational treatments that are not yet available to the general public.
- They will have regular visits and close monitoring from both the MD and research nurse as required by the clinical trial.
- Many of the MDs involved in research are “top doctors” in the field of breast cancer.
- Part of your treatment may be covered by the study, thus lowering your overall cost.
- Study participants are also encouraged by the fact that they are taking an active role in their treatment and that they may be helping to save the lives of breast cancer patients in the future.
How do I decide if a clinical trial is right for me?
When considering whether or not to participate in a clinical trial, a patient should ask the following questions:
- What type of treatment is being studied?
- Why do doctors feel this treatment might be effective?
- What are the different treatments that I might receive on this study?
- What are the risks, side effects and benefits of the study medication(s) offered on this trial?
- What tests and procedures will I have to have?
- How many office visits will I have on this study?
- How long will I be in the study?
- What is paid for by the study and what will be billed to my insurance?
- Are there any long-term side effects associated with the study drugs?
Leslie Verner RN, BSN, OCN, CCRP, CBCN, is an Adult Research Nurse, certified in Breast Cancer Nursing for the Mission Cancer Program.