Clinical Research

“Clinical research” is the broad term that includes the process by which any new medication or medical device becomes FDA approved. Without this approval, a company cannot market a product for human use in the US. The path to FDA approval begins with “lab” research. This is where the basic science of a drug is worked out. Today, this often involves computer modeling and very high-tech methods.

Once a drug show promise in the lab, it is tested in animals to make sure that it is both safe and has potential to work. If this test is passed, the drug moves into human testing. This part of the approval process is divided into three phases:

Phase I
The drug is given to a small number of people to evaluate its safety, determine a safe dosage range, and identify side effects.

Phase II
The drug is given to a larger number of people to see if it is effective and to further evaluate its safety. Safety remains the primary question and a drug must pass this “safety test” without question to move to the next phase.

Phase III
The drug is given to a very large number of people to further study its effectiveness and side effects. Effectiveness is the main subject with safety still being important.

During the trial

Almost every clinical trial will consist of the following visits:

Screening Visit:  The screening visit often occurs during one visit to the clinic but can last for a certain window of time that gives the study team enough time to assess your eligibility for participation.

Randomization Visit:  This visit occurs once your eligibility to participate in the clinic trial is verified and your treatment begins.

General Study Visits:  At these visits the study team will collect information from you about any changes in your medication or general health. Vitals, labs, EKG or other tests may be administered.

End of Study Visit:  This visit establishes the safety and efficacy of the study medicine during your trial participation

Your Rights in a Clinical Trial

You have the right to:

• The very best care
• Ask questions and get answers at any time
• Know what other treatment options may be available to you
• Confidentiality and privacy – your personal identifiers will be removed from study documents
• Withdraw from a clinical trial at any time

People choose to participate in a clinical trial for many reasons:

• Participants may be compensated for time and travel, depending on the study
• Opportunity to benefit from new treatment options
• Play an active role in your care
• Contribute to saving lives in the future
• Quality care from top doctors and researchers

At UCA, you, the patient, are the main focus of any clinical study – your rights, protection and safety are our top priority.  Making sure all patients fully learn and understand their rights before any trial is key.

Informed consent is a process used by researchers to provide potential and enrolled participants with information about a clinical study. This information helps people decide whether they want to enroll or continue to participate in the study.

The informed consent process is intended to protect participants and should provide enough information for a person to understand the risks of, potential benefits of, and alternatives to the study. Participants may withdraw from a study at any time, even if the study is not over.