When you or a loved one is diagnosed with cancer, learning about what a clinical trial is and deciding what treatment to pursue can be daunting. When you’ve exhausted the available cancer treatment options, whether through radiation oncology, hematology-oncology or some other specialty, it can be scary to think that’s there isn’t a treatment option left. Fortunately, clinical trials can provide hope and alternative treatment options for cancer patients who need them.
What Are Cancer Clinical Trials?
Clinical trials are the last phase in getting regulatory approval for new pharmaceutical medications, devices or protocols. After months or years of research and testing in the lab and, in many cases, on animals, human testing is needed to ensure safety and effectiveness. Clinical trials are conducted at many research institutions, hospitals, and community based clinics (or practices) around the world.
Why Clinical Trials Exist
Clinical trials exist to get new treatment options to patients. For instance, a clinical trial about investigational breast cancer treatments may lead to more successful outcomes for breast cancer surgeons and their patients. In addition to measuring safety, clinical trials can determine if a new therapy works, makes no difference or further impairs patients.
Who Benefits From Clinical Trials
Many people benefit from clinical trials. First, patients involved in clinical trials receive life-saving treatment earlier than it would normally be available. This is ideal for cancer patients who haven’t responded to approved therapies. For patients who cannot afford treatment, involvement in a clinical trial is sometimes at no cost to the patient. Second, researchers, doctors, and pharmaceutical manufacturers benefit by having humans to test their experimental cancer treatments on.
Third, no matter what the outcome of the trial, future cancer patients strongly benefit from clinical trials. If a new medication or treatment proves to be successful, future patients will be able to use it as a regular part of their treatment. If the clinical trial fails, future patients will not be exposed, and researchers can identify drugs that could provide better outcomes in the future.
How Clinical Trials Are Conducted
Human clinical trials are conducted in three different phases. Depending on the actual trial, there might be more phases. The first phase involves a small number of patients, and the primary concern is the safety or side effects of the treatment. Clinical trials do not aim to hurt people, so at first, the first phase stays small so researchers can closely monitor what happens. This phase happens after a lot of research has already been conducted in the lab, so there is less chance of a foreseeable adverse reaction.
The second phase also uses a small group of people. Instead of just focusing on safety, this phase examines how well the proposed treatment works. If the results still look promising, a third phase involves a larger number of people with less stringent guidelines. For example, if an earlier phase only allowed geriatric patients to be involved, this phase might expand the parameters to evaluate possible side effects and compare alternative treatments to see which is better for whom.
How to Participate in a Clinical Trial
For patients interested in participating in a clinical trial, the first step is to try conventional cancer treatment options, if possible. Many trials will ask what you’ve already tried. Next, patients need to find clinical trials through online databases, their oncologist or a local cancer center to see who’s eligible to participate.
Maryland Oncology Hematology currently has active clinical trials for breast cancer, lung cancer, Chronic Lymphocytic Leukemia (CLL), metastatic malignancies, multiple myeloma, supportive therapies and gastric cancers. These include clinical trials for many different stages of these cancers. To participate, you should ask your oncologist or contact Maryland Oncology Hematology directly.