What is a clinical trial?
Clinical trials are carefully supervised research studies, whereby new investigational treatments and medications are evaluated for safety and effectiveness by a medical team.
The Food and Drug Administration (FDA) requires all pharmaceutical companies to thoroughly test new medications before they become available to consumers. All medications in use today – prescription and over-the-counter – were first proven safe and effective in clinical trials.
Each trial follows a pre-defined plan, or protocol, which describes what types of patients may enter the study, schedules of tests and procedures, drugs, dosages, and length of study, as well as outcomes that are measured.
Why participate in a clinical trial?
Participants in clinical trials can play a more active role in their own healthcare, gain access to new research treatments before they are widely available, and help others by contributing to medical research. Additionally, since investigators are often specialists in the disease being studied, participants also receive expert medical care for the specific condition.
By participating in a clinical trial, you may help in the development of new medical therapies. These therapies, if proven to be safe and effective, can help improve the quality of life by offering better treatments and even cures for people with life-threatening and chronic diseases.
Clinical research studies offer volunteers the benefits of free physical exams, study related medical testing and study medication. Many studies offer compensation for your time and travel and transportation is provided if needed.
Who can participate in a clinical trial?
Since people respond differently to medicines and other treatments, it is important to include all kinds of people in a clinical research study. 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. These criteria are based on such factors as age, gender, the type and stage of a disease, previous and current treatment history, and other medical conditions. A participant must qualify for the study before being consented for a clinical trial.
Will my information be kept confidential?
When you participate in a clinical trial your privacy is protected. Your medical records are confidential. The trial data that is provided to the pharmaceutical company and the FDA will not include your name or the names of other individuals participating in the study.
What is the cost?
There is no cost for study-related physician visits or medications.
What are the possible benefits and risks of participating in a clinical trial?
- Gain access to new research treatments before they are widely available
- Help others by contributing to medical research
- Possible compensation for participation
- Patients have access (at no cost) to expert monitoring and medical care for trial-related conditions, as well as for some underlying conditions that might be detected
- The treatment may not be effective for the participant
- There may be unpleasant, serious or even life-threatening side effects to experimental treatment
- Participation in the trial may be demanding and time consuming
How is the safety of the participant protected?
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.
If you are interested in screening for any of our trials, please call us at (773) 275-3500 or contact us through this website by clicking here.