1. What is a Clinical Trial?
A clinical trial or research study is a scientific study that evaluates the safety and effectiveness of investigational drugs or devices.
The Food and Drug Administration (FDA) requires the safe and satisfactory completion of research studies before it will consider an investigational drug for approval and public use. Clinical studies are divided into 4 phases:
- Phase I: Researchers test an investigational drug for the first time in humans by giving it to a small number of healthy people to evaluate its safety, determine a safe dosage range, and identify side effects.
- Phase II: The investigational drug is given to a larger number of people who have a particular disease or condition, to determine its effectiveness and to further evaluate its safety.
- Phase III: Several hundred to several thousand people with the appropriate disease or condition participate in these studies. The investigational drug undergoes additional testing to further determine its safety and effectiveness, monitor side effects, and compare it to commonly used treatments.
- Phase IV: After a drug is available by prescription, additional information is gathered to assess the drug’s risks, benefits, and use.
2. Why should I participate in a Clinical Trial?
You can learn new information about your health.
Each year thousands of people volunteer to participate in research studies. As a volunteer, you may:
- Participate in a research process that may lead to new treatment options for people in the future at risk for having a heart attack or other cardiovascular events.
- Learn new information about your health.
- Receive study-related care from qualified physicians.
- Have a positive impact on the health and future of people with conditions like yours.
3. Who can participate in a study?
Participants vary based on the criteria of the study.
Each study will have inclusion and exclusion criteria. Inclusion criteria are the factors that allow a person to participate. Exclusion criteria are the factors that do not allow a person to participate. These criteria will include age groups, gender, current medictions and medical history.
4. Can I stop participating in a study at any time?
Yes, you can.
Your participation is completely voluntary and you may withdraw from the study at any time.
5. What questions should I ask if I am interested in participating in a trial?
What are the benefits and risks associated with this study?
Here are some questions you may wan to discuss with you study doctor:
- What is the purpose of this clinical study?
- How long will I be in the study?
- How often will I need to go to my clinic/hospital?
- What tests and procedures are involved?
- Will my medical records remain confidential?
- Is there a chance I will receive a placebo?
- What are the benefits and risks associated with this study?
- How do the benefits and risks compare with those of my current treatment?
- Is follow-up care part of this study?
- How will my condition be monitored?
- What safeguards will be in place for my protection?
- Will results of the study be provided to me?
Contact your study doctor for more information about participating in a clinical study.
6. What are the potential risks and benefits?
According to the National Institutes of Health (www.clinicaltrials.gov), there are multiple benefits and risks associated with participating in a clinical study.
Benefits
Clinical studies that are well-designed and well-executed to 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.
- Obtain expert medical care at leading health care facilities during the study.
- Help others by contributing to medical research.
Risks
There are risks to clinical studies:
- There may be unpleasant, serious, or even life-threatening side effects to experimental treatment
- The experimental treatment may not be effective for the participant.
- The protocol may require more time and attention than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays, or complex dosage requirements.
You should talk with your doctor and carefully consider both the potential benefits and risks of participation before enrolling in a clinical study; however, if you qualify, the actual decision whether to participate is yours to make.
The Center for Clinical Trials 