Why participate in a clinical trial?
Who can participate in a clinical trial?
What happens during a clinical trial?
What is Informed Consent?
What are the benefits and risks of participating in a clinical trial?
How is the safety of the participant protected?
What should people consider before participating in a trial?
Does a participant continue to work with a primary health care provider while in a trial?
Can a participant leave a clinical trial after it has begun?
What is a protocol?
What is a placebo?
What are the phases of clinical trials?
Participants in clinical trials, also called research studies, may gain access to new research treatments before they are available, and may help others in the future by contributing to medical research.
Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results. 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. Before joining a clinical trial, a participant must qualify for the study.
The clinical trial team includes doctors and nurses as well as social workers and other health care professionals. They check the health of the participant at the beginning of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial, and stay in touch after the trial is completed.
Informed Consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. The Study Coordinator will explain the details of the study, as well as the risks and benefits of participating. Potential study participants (and caregivers, when applicable) will have the chance to ask questions about the study. If a potential study participant decides to participate, he/she will be asked to sign an Informed Consent document, which includes details about the study, such as its purpose, duration, required procedures, and key contacts. Participants may decide to withdraw from the study at any time, for any reason, even if he/she has signed the Informed Consent.
Clinical trials that are well-designed and well-executed are the best approach for eligible participants to:
- Play an active role in their own health care.
- Gain access to new research treatments before they are widely available.
- Help others by contributing to medical research.
There are also risks to clinical trials:
- There may be unpleasant, serious or even life-threatening side effects to treatment.
- The treatment may not be effective for the participant.
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.
People should know as much as possible about the clinical trial and feel comfortable asking the members of the study team questions about it, 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 study team. Some of the answers to these questions are found in the Informed Consent document.
- What is the purpose of the study?
- Who is going to be in the study?
- Why do researchers believe the new investigational treatment being tested may be effective? Has it been tested before?
- What kinds of tests and investigational 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?
- What type of long-term follow up care is part of this study?
Yes. Most clinical trials provide short-term investigational treatments related to a designated 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.
Yes. A participant can leave a clinical trial, at any time. When withdrawing from the trial, the participant will be asked to let the research team know about it, and the reasons for leaving the study.
A protocol is a written study plan on which the clinical trial is based. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, study medications, and dosages; and the length of the study.
A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the study treatment's effectiveness.
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 investigational 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.
Source: CISCRP (The Center for Information and Study on Clinical Research Participation) www.ciscrp.org