What are clinical trials
Clinical trials are research studies designed to answer specific questions about investigational medications that may benefit future patients and current research participants. The trials are designed to assess both the safety and effectiveness of a product and are carefully conducted under strict U.S. Food and Drug Administration (FDA) guidelines.
Trial Phases
Phase I - researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate it's safety, determine a safe dosage range and identify side effects.
Phase II - the experimental treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
Phase III - the experimental treatment is given to larger groups of people (1,000-3,000) to confirm it's effectiveness, monitor side effects, compare it to commonly used treatments and collect information that will allow it to be used safely.
Phase IV - postmarketing studies delineate additional information, including the treatment's risks, benefits and optimal use.
CLICK HERE FOR OUR CURRENT STUDIES LIST
What to expect as a research study participant:
Pre-Screening
Initial conversation by phone or in the clinic with a study team member to tell you about the study.
Informed Consent
An explanation of your rights and obligations as a participant in a research study.
Screening
To determine if you meet the basic study requirements, medical history, list of current medications, vital signs, lab work and other procedures may be performed.
Enrollment/Randomization
You are enrolled in a study and given a treatment assignment. You and your doctor may not know what you receive.
Study Visits
Some visits may be days, weeks or months apart, based on the study requirements. There may be different assessments at different visits. Physical exam, labs, ECG, questionnaires or other tests/procedures may be performed.
End of Study Treatment
You will no longer receive study treatment or placebo. Other assessments may be performed at this visit.
Follow-up Period
A study team member may call you, or you may have an office visit to assess how you are doing after ending study treatment.
Completion
Your participation in the study has ended. An office visit may be required to complete all safety assessments.
Trial Phases
Phase I - researchers test an experimental drug or treatment in a small group of people (20-80) for the first time to evaluate it's safety, determine a safe dosage range and identify side effects.
Phase II - the experimental treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
Phase III - the experimental treatment is given to larger groups of people (1,000-3,000) to confirm it's effectiveness, monitor side effects, compare it to commonly used treatments and collect information that will allow it to be used safely.
Phase IV - postmarketing studies delineate additional information, including the treatment's risks, benefits and optimal use.
CLICK HERE FOR OUR CURRENT STUDIES LIST
What to expect as a research study participant:
Pre-Screening
Initial conversation by phone or in the clinic with a study team member to tell you about the study.
Informed Consent
An explanation of your rights and obligations as a participant in a research study.
Screening
To determine if you meet the basic study requirements, medical history, list of current medications, vital signs, lab work and other procedures may be performed.
Enrollment/Randomization
You are enrolled in a study and given a treatment assignment. You and your doctor may not know what you receive.
Study Visits
Some visits may be days, weeks or months apart, based on the study requirements. There may be different assessments at different visits. Physical exam, labs, ECG, questionnaires or other tests/procedures may be performed.
End of Study Treatment
You will no longer receive study treatment or placebo. Other assessments may be performed at this visit.
Follow-up Period
A study team member may call you, or you may have an office visit to assess how you are doing after ending study treatment.
Completion
Your participation in the study has ended. An office visit may be required to complete all safety assessments.
