Clinical Research: Clinical research is medical research that involves people to test new treatments and therapies.

Healthy Volunteer: A Healthy volunteer is a person with no known significant health problems who participates in clinical research to test a new drug, device, or intervention.

Inclusion/Exclusion Criteria: Inclusion/Exclusion Criteria are factors that allow someone to participate in a clinical trial are inclusion criteria. Those that exclude or not allow participation are exclusion criteria.

Informed Consent: Informed consent explains risks and potential benefits about a clinical trial before someone decides whether to participate.

Patient Volunteer: A patient volunteer has a known health problem and participates in research to better understand, diagnose, treat, or cure that disease or condition.

Phases of Clinical Trials: Clinical trials are conducted in “phases.” The trials at each phase have a different purpose and help researchers answer different questions.

  • Phase I trials — An experimental drug or treatment in a small group of people (20–80) for the first time. The purpose is to evaluate its safety and identify side effects.
  • Phase II trials — The experimental drug or treatment is administered to a larger group of people (100–300) to determine its effectiveness and to further evaluate its safety.
  • Phase III trials — The experimental drug or treatment is administered to large groups of people (1,000–3,000) to confirm its effectiveness, monitor side effects, compare it with standard or equivalent treatments.
  • Phase IV trials — After a drug is licensed and approved by the FDA researchers track its safety, seeking more information about its risks, benefits, and optimal use.

Placebo: A placebo is a pill or liquid that looks like the new treatment but does not have any treatment value from active ingredients.

Protocol: A Protocol is a carefully designed plan to safeguard the participants’ health and answer specific research questions.

Principal Investigator: A Principal Investigator is a doctor who leads the clinical research team and, along with the other members of the research team, regularly monitors study participants’ health to determine the study’s safety and effectiveness.

Randomization: Randomization is the process by which two or more alternative treatments are assigned to volunteers by chance rather than by choice.

Single- or Double-Blind Studies: Single- or double-blind studies (also called single- or double-masked studies) are studies in which the participants do not know which medicine is being used, so they can describe what happens without bias.

Types of Clinical Trials

  • Diagnostic trials determine better tests or procedures for diagnosing a particular disease or condition.
  • Natural history studies provide valuable information about how disease and health progress.
  • Prevention trials look for better ways to prevent a disease in people who have never had the disease or to prevent the disease from returning.
  • Quality of life trials (or supportive care trials) explore and measure ways to improve the comfort and quality of life of people with a chronic illness.
  • Screening trials test the best way to detect certain diseases or health conditions.
  • Treatment trials test new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.

Contact information

  • CarePoint Health Research InstituteChrist Hospital (3E)
    176 Palisade Ave
    Jersey City NJ, 07306
    Phone: 201.795.8554
    Fax: 201.683.2718
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