FAQ about Clinical Trials
Why do we need clinical trials?
Clinical trials contribute to knowledge and progress against disease. If a new treatment proves effective in a study, it may become a new standard treatment that can help many patients. Many of today's most effective standard treatments are based on previous study results. Clinical trials may also answer important scientific questions and suggest future research directions. Because of progress made through clinical trials, many people treated for diseases are now living longer.
What are the benefits of participating
in a clinical trial?
The patients who take part may be helped personally by the treatment(s) they receive. They get up-to-date care from experts, and they receive either a new treatment being tested or the best available standard treatment for their disease. Of course, there is no guarantee that a new treatment being tested or a standard treatment will produce good results. New treatments also may have unknown risks. But if a new treatment proves effective or more effective than standard treatment, study patients who receive it may be among the first to benefit. Some patients receive only standard treatment and benefit from it.
Is it safe to participate in a clinical trial?
There are rigorous guidelines in place to protect the well-being and safety of clinical trial participants. The physician and research nurse conducting the study will explain any known or anticipated risks ahead of time. In addition, the protocol (study design) of your trial may take up more of your time than standard treatment - more trips to the study site, more treatments or hospital stays, or more complicated medication schedules.
What types of clinical trials are there?
Phase I trials are early studies intended to find out the amount of the drug that works best and how much can be given safely. A small dose is given and then gradually increased while doctors watch closely for unnecessary side effects.
Phase II trials also test the safety of the treatment and seek to determine if the treatment is effective. If the treatment works, doctors will plan a Phase III study. If the treatment does not work, no further trials will be conducted.
The goal of Phase III trials is to find out if the new treatment is more or less effective than the standard treatment. Phase III trials involve a larger number of subjects and are the type of trials that cancer patients most often join.
A randomized trial is a study in which patients are put into a treatment group by chance. One group will receive the new treatment being studied and the other will receive the standard treatment.
In a single-blind trial, patients do not know which treatment group they are in. In a double-blind trial, neither the patient nor the doctor knows which treatment group the patient is in. Blinded trials are intended to make sure that the results are not biased by anyone's hopes for a certain treatment.
What are my rights as a participant in a clinical trial?
Since World War II, government organizations worldwide have declared that you have specific rights if you agree to participate in a clinical trial. No one can take these from you.
You have the right to join a research study only if you wish to do so. You should never be pressured or coerced to join a study.
You have the right to leave a research study whenever you want. You should never be pressured or coerced to stay in a study. You cannot lose access to your regular medical care if you leave a study.
You have the right to full and complete information about what the study means for you personally. This is the process of informed consent.
You have the right to ask questions about the study, both before it begins and as it continues.
You have the right to know about alternative options. When you evaluate a clinical trial of a new medication, you should receive information about other treatments (if any) that exist.
You have a right to join a clinical trial if you meet the eligibility criteria. You should not be excluded on the basis of age, sex, race, or any other characteristic unless this is explicitly stated in the approved protocol.
What is an Informed Consent?
The informed consent document is a written description of what will happen in the study, and the document generally includes the following sections:
Introduction -- A general reminder about your rights as a study participant.
Purpose of the Study -- A brief statement about why researchers plan to do the clinical trial. It should mention whether you will take any experimental medications not yet approved by the federal government.
Subject Selection -- A description of how many people will enroll in the study and what the selection criteria are.
Procedure -- An explanation of all of the tests and procedures that you will undergo, such as hospitalizations, clinic visits, questionnaires, and laboratory tests.
Risks and Discomforts -- A list of all the risks the clinical trial may contain, such as side effects or complications from medications or medical procedures. Researchers should also explain how common these risks are.
Benefits -- A description of the direct benefits you can expect. In clinical trials that test new medications, benefit from those medications is not included, since researchers do not yet know what the benefits will be.
Alternatives -- An explanation of your options if you do not participate. These include using standard therapies for specific medical conditions.
Participation and Withdrawal -- A reminder about your right to leave the clinical trial at any time, and an explanation of reasons that a researcher may remove you from a trial.
Cost or Payment -- A list of expenses that you can expect and any compensation you will receive.
Injuries -- A statement about who will pay for your medical care to treat research-related injuries. Federal guidelines require that this section be included in all informed consent documents, even for clinical trials that pose minor risk.
Confidentiality -- A description of how researchers will ensure that information from the clinical trial remains private and confidential.
Clinical trials differ in what they involve, so some informed consent documents may not include all of these sections. In some clinical trials, the informed consent document may be several pages, but you should read it carefully. Only when you understand it fully should you join a clinical trial. If parts are complicated or unclear, ask for clarification until you are satisfied. Keep a copy of the document because you may have questions later.
What is the informed consent process?
Informed consent is the process of giving you all of the information that you need to make an informed decision about a research experiment. Informed consent has several parts:
Researchers clearly and accurately describe
what the clinical trial involves.
Researchers provide all of the information in writing in the informed consent document.
You review the information and ask as many questions as needed.
Always check with your insurance company to review their policy regarding participation in a research study.
You decide whether to join and sign the informed consent document.
You receive a copy of the signed informed consent document.
Links for further information on research:
FDA = http://www.fda.gov/
OHRP = http://www.hhs.gov/ohrp
DHHS = http://www.hhs.gov/
NIH = http://www.nih.gov/
ARENA/PRIM&R = http://www.primr.org/
ORI = http://www.dhhs.gov/