Information about Clinical Trials
What you should know about clinical trials
Researchers conduct clinical trials to evaluate the safety and effectiveness of investigational drugs. Bringing a new drug to market from the laboratory is a long and careful process. A clinical research trial, in which people volunteer to participate, is an important step along the path.
Why clinical research trials are important
Clinical research trials help determine whether an investigational medication works and is safe. After all the data are collected, researchers may gain a clearer picture of how an investigational medication behaves in the body, whether it is safe, and if it works in treating the medical condition for which it is being tested.
Even when clinical trials do not lead to new treatments, they may still be useful for scientists and for the advancement of medical research.
Eligibility
There are certain requirements that must be met to be eligible to participate in a clinical trial. These requirements are based on such factors as age, gender, the type and stage of a disease, previous and current treatments, and other medical conditions.
Informed consent
Before taking part in any trial activities, it is required by law for all clinical research trial participants to read, understand, and sign an informed consent form. Signing this statement indicates that you clearly understand the goals of the clinical research study and any associated risks and discomforts, and that you voluntarily agree to participate. This document also confirms that you are free to withdraw from the trial at any time.
Phases of Clinical Trials
Clinical trials 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 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 trials. 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.
Potential Benefits and Risks Associated With Clinical Research Studies
According to the US National Institutes of Health (www.clinicaltrials.gov), there are multiple benefits and risks associated with participating in clinical trials.
Benefits
Clinical trials are a way for eligible participants to:
- Play an active role in their own healthcare
- Gain access to new research treatments before they are widely available
- Obtain expert medical care at leading healthcare facilities during the trial
- Help others by contributing to medical research.
Risks
There are risks to clinical trials:
- There may be side effects to the experimental treatment
- The experimental treatment may not be effective for the participant
- The protocol may require more time and attention than would a nonprotocol treatment.
Questions You May Want to Ask Your Doctor
What is the purpose of this clinical trial?
How long will I be involved in the trial?
How often will I need to go to the trial site?
What should I expect of the trial visits?
What tests and procedures are involved?
Is there a chance I will receive a placebo?
What are the benefits and risks associated with this clinical trial?
Is follow-up care part of this trial?
Will results of the trial be provided to me?
Contact your study doctor for more information about participating in a clinical trial.
You can find more clinical trial information at www.clinicaltrials.gov.
To learn more about the READY clinical trial, click here.