Clinical trials are research studies in which people help researchers and doctors find ways to improve health and cancer care
Cancer clinical trials are designed to answer questions about new ways to:
- Treat cancer
- Find and diagnose cancer
- Prevent cancer
- Manage symptoms of cancer or its treatment
Advances in the treatment of cancer depend on the conduct of clinical trials. A patient diagnosed with any type of cancer normally receives what is known as standard of care – treatment accepted by the oncology profession as the best known treatment. A clinical trial uses promising new therapies to treat consenting patients. These therapies are standard of care plus additional or substitute therapy that has scientific evidence of benefit for the cancer being treated. Standard of care only advances as clinical trials prove additional benefit of the tested therapy.
Clinical trials result in improved treatment for future cancer patients
Clinical trial patients receive close observation during their treatment so that side-effects and tumor responses can be carefully followed and compared to patients receiving standard of care. In addition to treatment, patients may consent to the use of tissue samples taken from their surgery to help doctors understand the biology of the tumor. Clearer understanding of the biology of a patient’s tumor may one day lead to individually developed therapy based on the patient’s own genetic make-up.
When new therapies are proven to be beneficial including better tumor responses, fewer side-effects, or improved quality of life, the new therapy becomes the standard of care and improves cancer survival and treatment for future cancer patients.
Benefits to participating in a clinical trial:
- Play an active role in your own health care.
- Gain access to new treatments before they are widely available.
- Obtain the highest quality medical care at leading health care facilities.
- Help others by contributing to medical research.
Drawbacks to participating in a clinical trial:
- New treatments may not be better than the standard care.
- New treatments may have unexpected side effects.
- The new treatment may not work for you.
- Health insurance may not cover the your medical costs if you participate in a clinical trial.
The National Comprehensive Cancer Network (NCCN) states,
“The best management for any patient with cancer is in a clinical trial.”
MCC has more than 100 treatment, prevention and cancer control trials open for accrual. MCC members include nearly every medical oncologist and board certified radiation oncologist in the state of Montana and northern Wyoming. MCC physicians have accrued more than 4000 patients to treatment, prevention, and cancer control trials through the CCOP mechanism.
Ask your doctor if you may be eligible to participate in a clinical trial.
Types of Clinical Trials
Several types of clinical trials are used depending on what researchers are studying
TREATMENT TRIALS are conducted with people who have cancer. They are designed to evaluate the effectiveness of new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
PREVENTION TRIALS are generally conducted with healthy people who have a history of cancer or a risk for developing cancer. These trials look for ways to prevent disease using medicines, vaccines, vitamins, minerals, or lifestyle changes.
CANCER CONTROL TRIALS (also known as supportive care) explore ways to improve comfort and quality of life for people who have cancer and are undergoing treatment. These trials explore ways to alleviate common side effects experienced with traditional cancer treatments.
CANCER CARE DELIVERY RESEARCH (CCDR) is a multidisciplinary science that seeks to improve clinical outcomes and patient well-being by intervening on patient, clinician, and organizational factors that influence care delivery. CCDR generates evidence that can be used to improve clinical practice patterns as well as develop and test promising interventions within the health care delivery system. It also supports development of new and generalizable knowledge about the effectiveness, acceptability, cost, optimal delivery mode, and causal mechanisms that influence outcomes and affect the value of cancer care across diverse settings and populations. The goal of CCDR is evidence-based practice transformation.
DIAGNOSTIC TRIALS help to find better ways of diagnosing cancer.
SCREENING TRIALS help to find better ways to detect cancer.
CLINICAL TRIALS are conducted in phases. The trials at each phase have a different purpose and help to answer different questions.
PHASE I TRIALS are conducted in a very small group of people to determine safe doses and identify side effects.
PHASE II TRIALS are conducted in larger groups of people to determine effectiveness and to further evaluate side effects.
PHASE III TRIALS are conducted in large groups of people to confirm effectiveness, monitor side effects, and compare to standard of care treatments.
PHASE IV TRIALS are conducted in very large groups of people to evaluate long-term safety and effectiveness. These trials are most commonly conducted after a new drug or therapy has been approved for use.
Each clinical trial has different eligibility criteria that determine whether a person can participate. The criteria are used to help researchers answer the study questions and to ensure the safety of all volunteers. Examples of eligibility criteria include the type and stage of disease, health history, and past or current treatment. If you are eligible for a clinical trial you will be given information that will help you decide whether or not to participate.