Clinical research leads to better medical care. New ideas often start in the laboratory, but eventually must be tested in the real world. A "clinical trial" is the name given to research that involves people as the subject of research. Our ability to diagnose, treat and prevent disease comes from the knowledge gained from these clinical trials.
Who can participate in a clinical trial?
All clinical trials have criteria about who can participate. These criteria are important for producing reliable results. For instance, people need to have a particular medical condition to be included in a clinical trial that evaluates a new treatment for that condition. Similarly, people may be excluded from a trial if they are too young or have other medical problems.
People who meet the criteria, are willing and able to participate, and provide informed consent can participate in a trial that is accepting new patients.
There are a variety of clinical trials recruiting patients to help study new treatments for major skin conditions.
What happens during a clinical trial?
The clinical trial process depends on the kind of trial being conducted.
What are the different types of clinical trials?
- Treatment trials look for new treatment options. These might include new medications, new dosages or combinations of medications, or new medical procedures.
- Prevention trials look for ways to prevent disease, including the use of medications, vaccines, vitamins, minerals, or lifestyle changes.
- Diagnostic trials look for better ways to diagnose illnesses.
- Screening trials are performed 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.
Should I consider participating in a clinical trial?
Participants in clinical trials help others by advancing medical science and may gain access to new treatment opions before they are widely available. Participants also benefit by playing an active role in their medical care,
Choosing to participate in a clinical trial is an important personal decision. It is often helpful to talk to your physician, family member or friends about deciding to join a trial. After identifying some trial options, the next step is to contact the study research staff and ask questions about specific trials.
You should try to get answers to the following questions?
- What is the purpose of the study?
- Who is going to be in the study?
- Why do researchers believe the experimental treatment being tested may be effective? Has it been tested before?
- What kinds of tests and experimental 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 experimental treatment?
- Will I be reimbursed for other expenses?
- What type of long-term follow up care is part of this study?
- How will I know that the experimental treatment is working? Will results of the trials be provided to me?
- Who will be in charge of my care?
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.The research staff involved in the trial explain the details of the study. Then 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 informed consent document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.
Can I participate in a clinical trial and still see my own doctor?
Yes. Most clinical trials provide short-term treatments related to a specific illness, but do not provide ongoing medical care.
You should inform your doctor of any plans you have to participate in a clinical trial to determine how best to coordinate appointments and determine if changes should be made to your existing treatment plan.
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:
- Phase I trials test an experimental medication or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage, and identify side effects.
- Phase II trials administer the experimental medication or treatment to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
- Phase III trials administer the medication or treatment 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 new treatment to be used safely.
- Phase IV trials (also called "post marketing studies") collect additional information about a treatment as it is used by a wider range of people and may evaluate long-term risks, benefits, and optimal use.
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Last updated: 1/8/2019