What is a Phase I clinical trial?
Phase I clinical trials are initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and the early evidence of effectiveness. These trials may include healthy participants, patients, or both.
Who can participate in a Phase I clinical trial?
All clinical trials have guidelines about who can participate. Using guidelines called inclusion/exclusion criteria, factors such as age, gender, the type and stage of disease, previous treatment history, and other medical conditions help doctors determine who is eligible for clinical trials. These guidelines identify appropriate participants, ensure safety, and help researchers answer the questions they plan to study.
Is it safe to participate in a Phase I clinical trial?
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. Every clinical trial follows a carefully controlled protocol (a detailed plan of exactly what researchers will do in the study).
What are the risk and benefits?
Benefits for patients may include the following:
- 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 trial
- Help others by contributing to medical research
Risks for patients may include the following:
- Unpleasant, serious, or even life-threatening side effects
- Possibility of ineffective treatment
- Requirement of more time and attention for the protocol than necessary for non-protocol treatment
What are side effects and adverse reactions?
Side effects are any undesired actions or effects of the experimental 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.
What should people consider before participating in a clinical 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 protocol, 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.
- 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?
To learn more, visit www.clinicaltrials.gov