When determining the right treatment for your type of cancer, your oncologist may suggest that you join a clinical trial. But what exactly is a clinical trial for cancer, and why would participating in one be a good idea for you?
Clinical Trials Defined
A clinical trial is how medical research is carried out by healthcare professionals for cancer and other diseases. They’re used to test a new drug or combination of drugs, new surgical procedures or devices, diagnostic tools and screening processes that will do a better job of detecting and treating specific types of cancer. Another goal of clinical trials is to improve cancer patients' outcomes using already approved cancer treatments in different ways for different types of cancer.
Each clinical trial clearly defines who is a candidate for participating. Participation requirements vary depending on what’s being tested, the type of cancer and stage of illness, and overall health of the patient. In many cases the patient must have already tried other established treatment protocols before they are eligible for the clinical trial. Your oncologist will review the exact requirements before recommending it as a treatment option.
Many patients decide to participate in clinical trials because they have exhausted other treatment options, or because the clinical trial gives them access to an effective and leading-edge cancer treatment.
How Clinical Trials Work
Clinical trials are always conducted in phases, with strict guidelines for participation set by the lead investigator(s). This doctor or group of doctors will carefully define who can and cannot participate in the trial so that it’s safe and likely to produce reliable results. The pharmaceutical company does not run clinical trials on their own. They use research organizations like US Oncology Research, and others, to conduct the research with actual patients under the careful monitoring of their oncologists.
Every clinical trial has a research or study plan that describes how the trial will be conducted, what will be carried out in the trial, and what each part of the trial includes.
Specific requirements must be met for a patient to join a clinical trial. These eligibility criteria vary but usually include:
- Medical history
- Age group
- Current health status
- Previous treatments received
- Type and stage of cancer
Before a new therapy is tested with cancer patients, there are always laboratory studies of the treatment first to provide sound scientific evidence that supports trials in humans.
Phases of Clinical Trials
There are four phases of clinical trials for cancer:
- Phase I: Aims to discover whether a drug, diagnostic test, device or surgical procedure is safe and identify side effects and appropriate doses. Phase 1 trials have fewer than 50 patients participating.
- Phase II: Aims to test whether a specific medical approach identified in Phase 1 trials is effective on certain cancers and obtain further information about side effects and appropriate dosages. Usually, there are less than 100 patients enrolled in these trials.
- Phase III: Aims to compare the new treatment(s) with the standard treatment and gather information on effectiveness. Large numbers of patients can join—more than 100 to thousands.
- Phase IV: Can be used in a few different ways. One is to try new combinations of already approved drugs for better outcomes or for a new type of cancer. Phase 4 trials can also be used on an existing cancer therapy to determine long-term effects on the patient’s quality of life.
Patients in some Phase 2-4 trials are divided into those receiving the new treatment (investigational group) and those standard receiving treatment (control group). For cancer trials, there is always a treatment given, even if it’s not the new therapy. Group assignment determination is done by computer randomization to avoid bias.
Are Clinical Trials for Cancer Safe to Participate In?
Every clinical trial has to abide by federal rules that help ensure safety and ethics.
The informed consent process involves your healthcare providers explaining to you details of the trial, including risks, benefits, purpose and procedures, and lab tests that will be needed before deciding to participate. They will also let you know about your rights regarding joining the clinical trial and your ability to leave the trial at any time if you decide to do so.
Informed consent also means that you can discuss the program whenever you need it with the healthcare provider conducting the study to clearly understand what is involved. Additionally, you will be given a written copy of the clinical trial protocol to sign if you decide to participate.
Ongoing review, approval, and monitoring of the trial by scientific experts, an Institutional Review Board (IRB), Data and Safety Monitoring Boards (DSMBs) for Phase 3 trials, the organization sponsoring the trial, and the research team are required.
If the drug being investigated in the trial does not appear to be working for you, your cancer care team will recommend you stop participating in the research trial and try another approach, if available.
Costs Associated with Participating in a Clinical Trial
You may be concerned about how to cover the costs of a clinical trial. Many patients wonder if their health insurance will cover costs such as physician visits, the medication or procedure being studied in the trial, laboratory or diagnostic tests needed, etc.
Your health insurance provider will sometimes pay for costs that are considered traditional treatments of cancer. Although not usually covered by health insurance, the costs of the drug(s) being studied or added diagnostic or lab tests carried out purely for research are typically covered by the trial's sponsor group. This typically means there are no unusual costs when participating in a clinical trial.
Questions to Ask About Clinical Trials
Before deciding to join a clinical trial, ask about the risks and benefits involved, how safety will be monitored, and what question the study is trying to answer.
- How will patients be monitored? Does this include lab work, radiology, or other diagnostic tests?
- How will access to treatment be more beneficial than your current or standard cancer treatment?
- Does participating in this trial require more doctor visits and have more diagnostic tests than my current or standard treatment?
- What are the possible or known side effects of the new treatment?
Your participation in a clinical trial may not only improve your cancer survival outcome but can help others with the disease in the present or future. It is ultimately your decision to join a clinical trial for cancer. Discuss your options with your doctor or oncologist, as well as your family, to make the right decision for you.
If you would like to talk about a clinical trial available here in Willamette Valley, our cancer research experts are available to discuss whether you would be a good candidate. Participation in trials locally is just one of the many advantages we offer to patients.