What is a clinical trial?
A clinical trial (also clinical research) is a
research study in human volunteers to answer specific health questions.
Carefully conducted clinical trials are the fastest and safest way to find
treatments that work in people and ways to improve health. Interventional trials
determine whether experimental treatments or new ways of using known therapies
are safe and effective under controlled environments. Observational trials
address health issues in large groups of people or populations in natural
settings.
Why participate in a clinical
trial?
Participants in clinical
trials can play a more active role in their own health care, gain access to new
research treatments before they are widely available, and help others by
contributing to medical research.
Who can participate in a
clinical trial?
All clinical
trials have guidelines about who can participate. 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. Some
research studies seek participants with illnesses or conditions to be studied in
the clinical trial, while others need healthy participants.
What are the benefits and risks of participating in a clinical trial?
Benefits:
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.
- Obtain expert medical care at leading health care facilities during the trial.
- Help others by contributing to medical research.
Risks:
- 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 of their time and attention than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements.
What should people consider
before participating in a 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 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 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?
- 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?
- Plan ahead and write down possible questions to ask.
- Ask a friend or relative to come along for support and to hear the responses to the questions.
- Bring a tape recorder to record the discussion to replay later.
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:
- In Phase I trials, researchers test a experimental 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 experimental 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 experimental 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 experimental 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.
>>for a more in-depth look at clinical trials, click HERE<<.
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Sources:
"An Introduction To Clinical Trials." ClinicalTrials.gov.
