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.
- CarePoint Health Research InstituteChrist Hospital (3E)
176 Palisade Ave
Jersey City NJ, 07306