Frequently Asked Questions About Clinical Trials
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Who is eligible to participate in a clinical trial?
Each study has its own guidelines, or eligibility criteria, 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. More
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.
For more information about clinical trials at Fox Chase Cancer Center or to find a study, call 1-888-FOX CHASE (1-888-369-2427).