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Frequently Asked Quetions

What are Clinical Trials?

Clinical trials test the safety and effectiveness of new treatments for cancer in select patients before they can be made widely available. Clinical trials may also evaluate new procedures or new approaches for cancer screening or prevention. Clinical trials involve very detailed and standard procedures for administering the new treatment or procedure and measuring its effects (both good and bad) on patients, compared to existing approaches. Clinical trials enable researchers and clinicians to test promising therapies to improve existing treatment options for patients.

What are the potential benefits and risks of participating in a clinical trial?

Each clinical trial offers potential benefits, and it can include certain potential risks. Clinical trials have some things in common, though. For the most part, clinical trial benefits include access to new drugs and treatments before they are widely available, close monitoring of your healthcare and any side effects, the chance for you to play a more proactive role in your own healthcare, and the opportunity to make a valuable contribution to cancer research. Potential risks may include the possibility that the new drugs and procedures have side effects that are not known to clinicians and/or that the new treatments are less effective than current approaches.

How are the University of Hawaii Cancer Center Participants Protected?

All University of Hawaii Cancer Center clinical trials are conducted according to strict scientific and ethical principles. Each trial is carefully designed to show how a particular anti-cancer treatment will affect the people who choose to participate. Before they are allowed to begin, all trials are closely reviewed by independent investigators, who ensure that the trials are scientifically sound and that they protect the safety of those who participate. Such reviews are required for all trials whether they are funded by the government, the institution or a pharmaceutical company. At the University of Hawaii Cancer Center, clinical trials are carefully examined by members of its Protocol Review and Monitoring System (PRMS), which focus on the science by asking, for example, whether the study is designed well and if the results will tell us something important. In addition, clinical trials are reviewed by an Institutional Review Board (IRB), which focuses on patient safety. Either the IRB or PRMS can stop a trial early if it is determined that a new treatment is not effective or if significant safety concerns arise.

Several federal government agencies also help ensure that all research is conducted with patient safety in mind. The Office of Human Research Protections (OHRP) is the government's main guardian of patient safety and welfare in clinical trials. It enforces the rules regarding the informed consent process (see below), institutional review boards (IRBs), and the participation of people with special needs in clinical trials, such as children and those with mental disabilities. The National Cancer Institute (NCI), part of the National Institutes of Health (NIH), sponsors many of the cancer clinical trials going on at any one time and conducts its own review of these studies before they are approved. The final authority on clinical trials is the Food and Drug Administration (FDA). The FDA reviews clinical trial information and decides whether the results of a study are safe and effective enough to be approved as a standard treatment.

Each person who enrolls in a clinical trial is informed about all aspects of a study's treatments and tests, including why each portion of the study is necessary, as well as its possible benefits and risks, prior to deciding to participate. The principal investigator (PI) of a study is required to obtain the informed consent (generally written) from all clinical trial participants prior to the start of the trial. During the informed consent process, the researchers (doctors or nurses) will explain the details of the study to participants and respond to any questions and concerns.

Who is Eligible to Participate in a Clinical Trial?

Each study has its own guidelines outlining who is eligible to participate. Participants are typically chosen because they share common conditions, such as the type and stage of cancer, age, or gender. University of Hawaii Cancer Center clinical trials are designed to benefit a broad scope of participants, with a variety of different types of cancer and having received a variety of past treatments.

What Happens Before a Clinical Trial begins?

Clinical trials are initiated only after a number of "pre-clinical" studies are performed and found to suggest that a proposed treatment is likely to be safe and effective. Pre-clinical studies include experiments performed on cancer cells grown in a laboratory and in laboratory animals. Although pre-clinical studies provide a lot of useful information, they do not give all the answers. For example, humans and animals may have different reactions to the way a new drug is absorbed and processed. A treatment that works against cancer in a mouse, for instance, may not work in people. If pre-clinical studies are completed and the treatment seems promising, the FDA must give permission to test the new treatment in humans.

How Can I Find Out if There is a Clinical Trial that is Right for Me?

Since each clinical trial has different enrollment criteria, we recommend that you and your physician look over the available clinical trials and contact the PI for further information. Your physician and PI will be able to help you identify if a trial is suitable for you, help explain the trial, and answer any other questions you may have.

Who is eligible to participate in a clinical trial?

Each study has its own guideline for who can participate. Generally, clinical trial volunteers are alike in key ways such as the type and stage of cancer, age, gender and other factors.

How are participants protected?

Research with people is conducted according to strict scientific and ethical principles. Every clinical trial has a protocol, or action plan, on how to conduct the trial. The plan describes what will be done in the study, how it will be conducted and why each part of the study is necessary. The same protocol is used by every doctor or cancer research center taking part in the clinical trial. All federally funded clinical trials as well as studies evaluating a new drug or medical device subject to Food and Drug Administration regulation must be reviewed and approved by an Institutional Review Board (IRB). Many institutions such as Fox Chase require that all clinical trials, regardless of funding, be reviewed and approved by a local IRB. An IRB includes doctors, researchers, community leaders and other members of the community.

Could I receive a placebo?

In treatment trials involving people with cancer, placebos ("dummy" pills or injections that contain no active ingredient) are sometimes used. Many treatment trials are designed to compare a new cancer treatment with the current standard treatment. Patients are randomly assigned to one group or another. In general, these studies would not use a placebo in place of active treatment. However, it is possible that a placebo could be used in addition to active treatment if the study was evaluating the addition of a new drug with unproven benefit. When no standard treatment exists for a cancer, a study may compare a new treatment with a placebo. In any study that involves a placebo, you will be told about this possibility during informed consent, before you decide whether or not to volunteer for the clinical trial.

What happens during informed consent?

Informed consent is a process in which people learn the key facts about a clinical trial to help them decide whether to participate. This information includes the purpose of the study, the tests and other procedures used in the study, expected benefits and possible risks. Informed consent continues as long as you are in the study. You can change your mind and leave a clinical trial at any time without penalty, even after signing the consent forms.

What is randomization and why is it important?

Randomization is a process that assigns clinical trial participants by chance, rather than by choice, to one of two (or more) groups. In large phase III trials, the "investigational group" receives the new cancer treatment under study. The "control group" or "reference group" receives the standard, currently accepted therapy. In smaller phase II trials, both groups are generally "investigational," but may involve a different dose and/or schedule of the new cancer treatment. Participants are randomly assigned so that bias does not weaken the study results. The goal is to have comparable groups with similar characteristics, such as age, gender, cancer type and cancer stage. In a well-balanced randomized trial, if one group has a better outcome than the other, the investigators may conclude with some confidence that one cancer treatment is better than the other.

Who conducts a clinical trial?

Every clinical trial has a person in charge, usually a doctor, who is called the protocol chair or principal investigator (PI). Clinical trial volunteers work with a research team led by the protocol chair or principal investigator. Team members may include doctors, nurses, social workers, dietitians and other health professionals. The team provides care, monitors participants' health and gives specific instructions about the study. It is important for participants to follow the research team's instructions so that the trial results are as reliable as possible.

Where do the ideas for clinical trials come from?

The ideas for clinical trials often originate in the laboratory. Researchers develop a clinical trial protocol (the plan for a trial) after laboratory studies show promise for a new drug or procedure. The first clinical trials of a particular drug or procedure focus on safety (phase I). Later trials focus on whether the drug or procedure is effective (phase II or phase III).

Who pays for the costs of a clinical trial?
Before taking part in a clinical trial, it's important to ask what your costs will be.

  • The study sponsor (such as the government, drug makers or technology companies) often pays for the cost of the new treatment, any special testing or extra doctor visits and research costs, such as data management.
  • Your medical insurance may be willing to pay for some or all of the costs of your treatment, depending on the type of clinical trial. Check with your provider before you begin treatment.
  • Medicare will pay for the routine costs associated with many clinical trials. Ask your doctor or call your local Medicare provider to find out what Medicare provides.

What happens when a clinical trial is over?

The researchers look carefully at the data collected from the trial before making decisions about the meaning of the findings and further testing. Clinical trial results are often published in peer-reviewed, scientific journals. Peer review is a process by which experts review the report before it is published to make sure the analysis and conclusions are sound. If the results are particularly important, they may be featured by the media and discussed at scientific meetings and by patient advocacy groups. Once a new approach has been proven safe and effective in a clinical trial, it may be applied as standard practice.

Before you decide to take part in a clinical trial, you should know more about it.

Protocol
Each study has a plan called a protocol. It explains all the facts about the clinical trial, such as:

  • The reason for doing the study
  • Who can join the clinical trial
  • How many people can take part in the trial
  • Any drugs someone in the trial will be given, the amount they are given, how often they will receive them and how it will be given to them
  • What medical tests are given and how often
  • What information will be gathered from the study

Informed Consent
Once you've decided to participate, an Informed Consent form is required.

Each study also has a process called informed consent. This is how you learn all the facts about the trial before you decide to take part. You must read these facts in a language you can understand and ask your doctor questions about anything you don't understand. You will get a form that explains:
  • Why the study is being done
  • All the facts about the treatment and tests
  • Possible risks and benefits
  • Alternative treatment choices
  • Your right to leave the study at any time
  • Any costs that might not be paid for
  • How your medical records will be kept private
If you agree to take part in a study, you will sign a consent form. Signing the form means you understand all the facts about the trial. Even after you sign the consent form, you can still choose not to be in the study at any time.

Things To Think About
All Treatments Have Both Benefits And Risks You may feel overwhelmed by the idea of a clinical trial. Here are some things to think about before you decide to take part.

Possible Benefits of a Clinical Trial
  • You may get a new treatment that is not yet open to people outside of the study
  • The research team will watch you closely
  • If the treatment being studied is better than the standard treatment, you may be first to benefit
  • The trial may help scientists learn more about cancer and help people in the future
Possible Risks of a Clinical Trial
  • The new treatment may not be better than, or even as good as, the standard treatment
  • New treatments may have side effects that your doctors do not expect
  • You may have to make more visits to the doctor than if you were getting standard treatment
  • There may be extra costs for these extra visits, like travel or child care
  • You may need more tests. Some of the tests could be uncomfortable or take a lot of time
  • Even if a new treatment works in some patients, it may not work for you.
  • Insurance may not cover all patient care costs

Questions to Ask
It's normal to have a lot of questions. Here are some questions you may want to ask a member of your healthcare team before you decide.

About this trial
  • Why is this trial being done?
  • How long will I be in the trial?
  • What kinds of tests and treatment will I have?
  • What are the possible side effects or risks of the new treatment?
  • What are the possible benefits of the treatment?
  • How will we know when the treatment is working?
  • Who is my trial care team?
  • What information will be shared with me?
  • How will my information be kept private?
  • What are my rights?
Costs
  • Will I have to pay for any of the tests or treatments?
  • What costs will my health insurance cover?
Daily Life
  • How could the trial affect my daily life?
  • How often will I have to come to the hospital or clinic?
  • Will I have to travel far to take part in the trial?
Comparing Treatment Options
  • What are my other treatment choices, including standard treatments?
  • How does the treatment I would get in the trial compare with other treatment choices?