Clinical Trials

You are the essential factor.

It’s important to understand, people like yourself are vital in this form of research. Clinical trials are essential for advancing medicine. They are designed with strong protections for patients and can give you access to new treatments before they are widely available. Clinical trials are research studies that test new ways to prevent, detect, or treat diseases. They are carefully designed to protect participants while answering important health questions.

Here’s what you can expect in a typical U.S. clinical trial:

  • Before testing in humans, researchers study the new treatment in laboratories and animals to see if it is safe and shows promise.

  • The company or researchers submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA). The FDA reviews the data to ensure the study can move forward safely.

  • Clinical trials in people usually happen in steps called phases:

    • Phase 1: Small group (20–100 people). Focus on safety, dosage, and side effects.

    • Phase 2: Larger group (100–300 people). Looks at how well the treatment works and continues to monitor safety.

    • Phase 3: Large groups (1,000+ people). Compares the new treatment to the standard of care, across many sites.

    • Phase 4: After FDA approval. Collects long-term safety and effectiveness data.

  • Not everyone can take part in every clinical trial. Each study has eligibility criteria to ensure the results are accurate and participants remain safe. These are called “inclusion” and “exclusion” criteria.

    • Inclusion criteria are requirements you must meet (such as having a specific condition, being within a certain age range, or having tried previous treatments).

    • Exclusion criteria are factors that prevent participation (such as other health problems, certain medications, or pregnancy).

    Eligibility is determined during a screening process, which may include medical history, lab tests, and physical exams.

  • Before joining, patients receive detailed information about the trial’s purpose, procedures, risks, and benefits. You can ask questions and must sign a consent form before participating. Participation is always voluntary—you can leave at any time.

    • Patients who meet eligibility criteria are enrolled.

    • In many trials, participants are randomly assigned to either the study treatment or a comparison group (placebo or standard treatment). This ensures fairness and accuracy of results.

  • Throughout the trial, doctors and researchers carefully monitor your health through check-ups, lab tests, and reports of side effects. Safety is the top priority.

  • Once the trial is complete, results are analyzed. If the treatment is proven safe and effective, the company submits a New Drug Application (NDA) or Biologics License Application (BLA) to the FDA for approval to make it widely available.

    • You may withdraw at any time.

    • Your personal health information is kept confidential.

    • You will be informed of any new risks or findings during the trial.

See Current Trials Running