Clinical research is a way for doctors and scientists to answer questions about healthcare. Research can find better ways to prevent, diagnose or treat diseases and disorders. There are many kinds of clinical research. For example, some studies test new medicines or devices. Other studies use interviews to learn about health problems.
A protocol is a written plan that describes the goal of a research study and how the study will be conducted. For example, it describes the type of people needed to take part in the study. The protocol also outlines any procedures the participants will undergo.
Drugs and medical devices must be proven safe and effective in people before the U.S. Food and Drug Administration (FDA) will approve them for general use. A clinical trial is a study that tests a drug or medical device to see if it is safe and effective for treating people. The government has strict rules for clinical trials. These rules help to ensure that study participants are safe.
Clinical trials that test drugs go through four stages or "phases."
A Phase I clinical trial is the first time an experimental drug is tested in humans. It is usually given to a small group of healthy participants. The purpose of a Phase I study is to gather information on the drug's safety.
A Phase II clinical trial is usually the second stage of testing a new drug in humans. This phase commonly involves 100 to 300 participants. The participants usually have the disease for which the experimental drug is being tested. The purpose of this phase is to gather additional information on safety and to see how effective the drug is.
A Phase III clinical trial commonly involves 1,000 to 3,000 participants that have the disease for which the experimental drug is being tested. This phase usually compares the experimental drug to the current approved treatment for the disease. Side effects and effectiveness are also monitored during a Phase III trial.
A Phase IV clinical trial is done after the drug has been approved for marketing. This stage of testing usually compares the drug to a competing drug or looks at the drug in new types of patients. Long-term side effects of the drug are also monitored in this phase.
Many types of people are needed to participate in research studies. Some studies need healthy persons. Other studies need persons with certain health problems. Persons of all ages and from all ethnic groups are needed.
Every study is different, and the reasons people participate are different. Some reasons people take part in a study are:
- To help others
- To possibly improve their own health
- To help advance science
- To gain access to treatments before they become widely available
- To access treatment options that might not be available outside of the research
The risks for each study are different. Some possible risks of taking part in a research study are:
- The experimental treatment may not be as good as or better than the standard treatment.
- If an experimental treatment is better than the standard treatment, it may not work for everyone.
- New drugs and treatments may have side effects that are unknown to the researchers.
- The Federal government has rules to protect study participants.
- All research studies in the United States must be approved and monitored by a group of people called an Institutional Review Board (IRB). The IRB is made up of scientists, doctors and community people. They review studies to help make sure that study participants will be as safe as possible.
- Participants must be given complete information about the research study. They must also give their informed consent before taking part in the study.
These methods of protection do not eliminate all possibility of risk. They do help to ensure study participants will be as safe as possible.
Before taking part in a study, each person will get a consent form that contains important written information about the study. It is important to read and understand the information in this form. The researcher or member of the research team will also talk to the person about the information contained in the form. The person should be sure all of his or her questions are answered before signing the consent form. A signed consent form is not a contract-a participant can leave a study at any time.
Before you decide to participate, you should ask as many questions as you need to in order to be sure you understand the study. Some questions you might want to ask are:
- What is the purpose of the study?
- Why am I being asked to take part in this study?
- Who is paying for the study?
- Who is doing the study and what are their qualifications?
- Where is the study being done?
- What kinds of tests or procedures will be done as part of this study?
- How will the treatment, tests or procedures differ from those I would receive if I did not participate in the study?
- How long will the study last?
- How will my safety be monitored?
- How will my privacy be protected?
- What are the risks, side effects and/or discomforts of this study?
- What are the possible benefits?
- What are the results of any previous studies performed?
- What are the alternative treatments and how effective are they?
- Will I have to pay for any part of the study?
- What expenses will my insurance carrier cover?
- What happens if I am harmed by the study?
- Is there follow up care available after the study?
- Who do I contact if I have questions related to this study?
