By Oncology Institute of Hope and Innovation
Researchers, scientists and doctors conduct clinical trials to learn more about cancer. They try to understand the causes, how to prevent or delay the development of cancer or how to treat symptoms.
A clinical trial is one of the final stages of a long and careful cancer research process. Before a clinical trial is held, researchers first conduct tests in the laboratory. However, lab research cannot predict all of the benefits, risks or effects that may occur in actual patients. That's where clinical trials come in.
During a cancer treatment clinical trial, information is gathered about a new treatment, its risks and how well it may or may not work. The goal of the study is to answer scientific questions that enable the medical community to find better ways to help people with cancer and to help determine if a promising new treatment is safe and effective.
The treatments that people with cancer receive today are the result of clinical trials done in the past. Without the benefit of the valuable information gained through clinical trials, medical research could not move forward.
Participating in a clinical trial can aid your loved one directly by giving him or her access to potentially helpful treatments before they are available to the general public.
Who Can Participate in a Clinical Trial?
Participation in cancer treatment clinical trials is always voluntary. If your aging parent is thinking about participating in a clinical trial – or is asked to participate in one – you and your loved one should learn as much as you can before making up your mind. Remember that your parent is in control of their medical treatment and they can change their mind at any time.
There are guidelines about who can participate in a clinical trial. Before joining a clinical trial, a participant must qualify for the study. A potential participant must meet certain criteria, which could include factors as age, gender, the type and stage of a disease, previous treatment history and other medical conditions. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants. The criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.
"Informed consent" provides potential participants information so that they can make an educated decision about whether or not to participate in a clinical trial. The research team lays out the trial's purpose, procedures, risks and potential benefits, and your parent's rights as a participant. The researchers will continue to provide information to you and your parent throughout the trial. Your loved one's signature on the informed consent document gives official consent to participate in the study, but your parent always retains the right to leave the study at any time for any reason. Ask for a printed document that includes all this information for your reference throughout the study and the trial.
Questions to ask before participating in a clinical trial
People should know as much as possible about the clinical trial and feel comfortable asking the members of the health care team questions about it. Here are some questions to ask before your elderly parent agrees to participate in a cancer clinical trial:
- What is the purpose of the study?
- What exactly is being studied?
- How long will the study last and how long will I be in the study?
- How many people will participate?
- Which phase of the study will I participate in?
- How often will I need to go to the hospital or clinic?
- What test will I need?
- Is there a chance that I will receive a placebo in the study?
- Will I continue to see my own personal doctor?
- Will there be any cost to me?
- Will participating in the study affect my daily life?
- What kind of long-term follow-up care is included in the study?
- Will I learn the results of the study? If so, when?
- What are the potential benefits and possible risks?
Where Do Clinical Trials Take Place?
They are underway all over the country - in cancer centers, other major medical centers, community hospitals and clinics, physicians' offices and veterans' and military hospitals in numerous cities and towns around the United States.
What Happens During a Cancer Treatment Clinical Trial?
What happens during a cancer treatment clinical trial depends on the kind of trial being conducted. Doctors may administer treatments, drugs or other therapies, depending on what they are studying. The participant will know exactly what to expect in terms of "what will be done to them." Your parent will receive specific instructions for participating in the trial. Researchers monitor participants carefully and check the health of the participant at the beginning of the trial. They will also likely stay in touch with your elderly parent after the trial is completed.
There are different types of clinical trials.
- Treatment trials test experimental treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
- Prevention trials look for ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vaccines, vitamins, minerals or lifestyle changes.
- Diagnostic trials are conducted to find better tests or procedures for diagnosing cancer.
- Quality of Life trials (or Supportive Care trials) explore ways to improve comfort and the quality of life for individuals with a chronic illness.
The risks and benefits of participating in clinical trials
Participating in a clinical trial comes with benefits and risks. Cancer clinical trials enable the person with cancer to:
- Play an active role in their own health care
- Gain access to new research treatments before they are widely available
- Obtain expert medical care at leading health care facilities during the trial
- Help others by contributing to medical research
However there are also risks to clinical trials.
- There may be unpleasant, serious or even life-threatening side effects to experimental treatment
- The experimental treatment may not be effective for the participant
- The protocol may require more of their time and attention than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements
Side Effects and Adverse Reactions
Side effects and adverse reactions may include headache, nausea, hair loss, skin irritation, or other physical problems. Experimental treatments must be evaluated for both immediate and long-term side effects.
Cost to Participate in a Clinical Trial
All research costs associated with a clinical trial are paid by the "research sponsor" or organization who is conducting the research. The sponsor can be a pharmaceutical company, research institution, or health organization, governmental agency or a philanthropic organization.
If your parent has other treatments that are not associated with the study, those costs, such as doctors' fees, hospital stays and lab tests are often not covered by the research sponsor.
It is important to understand that clinical trial health care is often considered "investigational" and not covered under medical plans. Discuss the financial aspects of participation in a clinical trial with both your parent's physician and with a representative of their insurance plan.
Medical science continues to advance the understanding of cancer and develop new and effective treatments. In many cases, life-saving treatments that define the current standard of care today were unheard of a decade ago, offering hope to patients who currently have few effective options.
The Oncology Institute of Hope and Innovation provides state-of-the-art medical care to cancer patients. Comprehensive and realistic treatment is tailored to every person's unique needs and decided upon in partnership with the patients and their families. For more information, visit www.theoncologyinstitute.com . (Some Information was compiled from the National Institutes of Health website.)