PARTICIPANT GUIDE

SAFETY IN CLINICAL RESEARCH

CLINICAL TRIAL PHASES

Clinical trials for treatments and vaccines typically have four phases, each of which is designed to answer different research questions. The phases are:

    • Phase 1: Safety
    • Phase 2: Efficacy
    • Phase 3: Comparison
    • Phase 4: Post-Marketing

If an intervention is successful in one phase, it may move on to the next phase. Each successive phase typically has a greater number of participants. Sometimes two phases are combined. In a Phase 3 study, each participant is randomly assigned to one of two groups. Only one group will receive the new intervention being studied; the other will receive the standard treatment for that disease.

Observational studies, such as prevention and quality-of-life studies, do not include an intervention, so they do not follow these phases.

BENEFITS

    • The treatments are free.
    • The access to the medical care in regards to the condition covered in the trial are free, with few exceptions.
    • Participants of our neurology clinical trials in Ozark often get paid for their participation.
Clinical Trials

HOW YOU ARE PROTECTED

    • Frequent visits to monitor symptoms and side effects.
    • Careful study plan, or protocol, that describes exactly what will happen in the study.
    • You will have an Informed Consent which tells you exactly what to expect in the study.
    • A clinical trial team member will go over each page of the consent and answer any questions you or your family members might have. You will be asked to sign this consent will receive a copy. Signing the Informed Consent just indicates you understand the details and want to participate in the study. You may revoke this consent at any time for any reason.
    • An Institutional Review Board is made up of doctors, scientists, and lay people like yourself, and they make sure every study in the United States does not expose the participants to any unnecessary risks.
    • The Data and Safety Monitoring Committee is made up of experts in your condition, and they monitor the results of the study throughout. If it is harmful or not effective, they stop the study immediately.

POTENTIAL RISKS

    • It may cause side effects or may not work for you.
    • You may not get the new experimental treatment.

    Feel free to call or email if you have questions anytime.

    Should you choose to participate in a clinical trial, please understand that our mutual commitment to the completion of the trial is critical. The very success of clinical trials hinges on completion.