Q: What is a placebo? A placebo is an inactive pill, liquid, or powder that has no treatment value, that is, it causes no harm, benefit, or other reaction in a participant. In clinical trials, experimental treatments are often compared with placebos to assess the treatment's effectiveness. In some studies, the participants in the control group will receive a placebo instead of an active drug or treatment. Q: What is a control or control group? A control is the standard by which experimental observations are evaluated. In many clinical trials, one group of patients will be given an experimental drug or treatment, while the control group is given either a standard treatment for the illness or a placebo. Q: What are the different types of clinical trials? Treatment trials test new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy. Prevention trials look for better ways to prevent a certain disease in people who have never had the disease or to prevent the disease from returning. These approaches may include medicines, vitamins, vaccines, minerals, or lifestyle changes. Screening trials test the best way to detect certain diseases or health conditions. Quality of Life trials (or Supportive Care trials) explore ways to improve comfort and the quality of life for individuals with a chronic illness. Q: What are the phases of clinical trials? Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions: In Phase I trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects. In Phase II trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety. In Phase III trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely. In Phase IV trials, post-marketing studies delineate additional information including the drug's risks, benefits, and optimal use. Q: Who can participate in a clinical trial? All clinical trials have guidelines about who can participate. The factors that allow someone to participate in a clinical trial are called "inclusion criteria" and those that disallow someone from participating are called "exclusion criteria". These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Using inclusion/exclusion criteria is an important principle of medical research that helps produce reliable results. Before joining a clinical trial, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, 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. Q: What happens during a clinical trial? The clinical trial process depends on the kind of trial being conducted (See What are the different types of clinical trials?) The clinical trial team includes doctors and nurses as well as social workers and other health care professionals. They check the health of the participants at the beginning of the trial, give specific instructions for participating in the trial, monitor the participants carefully during the trial, and stay in touch after the trial is completed. Some clinical trials involve more tests and doctor visits than the participant would normally have for an illness or condition. For all types of trials, the participant works with a research team. Clinical trial participation is most successful when the protocol is carefully followed and there is frequent contact with the research staff. Q: What is informed consent? Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. If the participant's native language is not English, translation assistance can be provided. Next, the research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time. Q: What kind of preparation should a potential participant make for the meeting with the research coordinator or doctor? Plan ahead and write down possible questions to ask. Ask a friend or relative to come along for support and to hear the responses to the questions. Bring a tape recorder to record the discussion to replay later. Q: What should people consider before participating in a 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 the trial, the care expected while in a trial, and the cost of the trial. The following questions might be helpful for the participant to discuss with the health care team. Some of the answers to these questions are found in the informed consent document. - What is the purpose of the study?
- Who will participate in the study?
- Why do researchers believe the new treatment being tested may be effective?
- Has the treatment being tested been tested before?
- What kinds of tests and treatments are involved?
- How do the possible risks, side effects, and benefits in the study compare with my current treatment?
- How might this trial affect my daily life?
- How long will the trial last?
- Will hospitalization be required?
- Who will pay for the treatment?
- Will I be reimbursed for other expenses (i.e. time off from work and childcare)?
- What type of long-term follow-up care is part of this study?
- How will I know that the treatment is working?
- Will results of the trials be provided to me?
- Who will be in charge of my care?
Q: Does a participant continue to work with a primary health care provider while in a trial? Yes. Most clinical trials provide short-term treatments related to a specific illness or condition, but do not provide extended or complete primary health care. In addition, by having the health care provider work with the research team, the participant can ensure that other medications or treatments will not conflict with the protocol. Q: What are side effects and adverse reactions? Side effects are any undesired actions or effects of drug or treatment. Negative or adverse effects 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. Q: What are the benefits and risks of participating in a clinical trial? Benefits : Well-designed and well-executed clinical trials are the best treatment approach for eligible participants to: - Play an active role in their 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.
Risks : There are risks to participating in a clinical trial. - There may be unpleasant, serious, or even life-threatening side effects to treatment.
- The treatment may not be effective for the participant.
- The protocol may require more of a participant's time and attention than would a non-protocol treatment, including trips to the study site and more treatments, hospital stays, or complex dosage requirements.
How is the safety of the participant protected? The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated with built-in safeguards to protect the participants. The trial follows a carefully controlled protocol, a study plan which details what researchers will do in the study. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies. Individual participants' names will remain private and will not be mentioned in these reports. Every clinical trial in the United States must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits. An IRB is an independent committee of physicians, statisticians, community advocates, and others that ensures that a clinical trial is ethical and that the rights of study participants are protected. All institutions that conduct or support biomedical research involving human participants must, by federal regulation, have an IRB that initially approves and periodically reviews the research. May a participant leave a clinical trial after it has begun? Yes. A participant may leave a clinical trial at any time. When withdrawing from the trial, the participant should make the research team aware of the withdrawal and the reasons for leaving the study.
For more information please visit: www.clinicaltrails.gov
Source: www.clinicaltrials.gov | 
