Adverse Event – an unexpected medical condition or side effect that a patient has during a clinical trial. It may or may not be caused by the trial treatment. An example of an Adverse Event would be when a patient reports having a severe headache that resolved with over-the-counter medication.
Clinical Trial – a research study that is conducted according to strict rules to test a new drug, treatment or device to determine whether it works and is safe. Clinical trials are also sometimes called clinical “studies” or clinical “research.”
ClinicalTrials.gov Identifier (NCT Number) – A unique order of numbers that is used to identify a clinical trial. The FDA assigns the NCT Number when a clinical trial is registered on clinicaltrials.gov. The NCT number always starts with ‘NCT’ and is followed by eight numbers (NCT 12345678).
Eligibility or Inclusion Criteria – The requirements of a clinical trial that identify the patients that are appropriate to participate in a specific clinical trial.
Enrollment – The number of people who are registered as clinical trial patients.
Exclusion Criteria – The criteria that would disqualify a patient from a specific clinical study.
Food and Drug Administration (FDA) – The US government agency that regulates the approval and marketing of medicines and devices for people and animals.
Informed Consent – A process to educate a study patient about the potential risks of a specific clinical trial and to get written permission - usually a signature – for participation. This process must be completed before participation in the study can begin.
Phase – To develop new medicines that treat diseases, researchers must first determine that they are safe. Clinical trials are split into four main phases, each of which involves more patients than the last. The safety of the drug is studied in every phase.
Phase 1 – These studies typically involve a small group of healthy volunteers to identify potential adverse events and how the treatment behaves in the human body.
Phase 2 – This phase can last up to 2 years and include several hundred people with the condition being studied. The purpose is to determine the how well the drug treats the condition and identify any side effects.
Phase 3 – Phase 3 studies are 1-4 years long and can enroll thousands of patients. The goal of phase 3 trials is to continue assess how the drug works in a larger population and monitor for side effects. Phase 3 studies tend to compare the treatment to a placebo or other common treatments for the condition being studied.
Phase 4 – These studies involve ongoing assessment of safety and efficacy after a drug is approved and on the market.
Placebo – A substance that does not provide treatment and is used compare the actual treatment to a baseline during a clinical trial. Placebos are also sometimes referred to as “sugar pills.”
Protocol – The written plan of a clinical trial that includes the design and purpose of the trial.
Sponsor – A drug company or organization that initiates and pays for a clinical trial.
Research center: term that represents the group conducting clinical trials. Examples of research centers include but are not limited to: independent research sites, health systems, hospitals, academic research centers, clinical research networks.
Premium Partner: a research center that is paying to promote their profile on TrialScout with the most exposure via logo placement and profile page distinction. Partners cannot pay to change their star rating on TrialScout.
Enhanced Partner: a research center that is paying to promote their profile on TrialScout with some exposure and profile page distinction. Partners cannot pay to change their star rating on TrialScout.
Basic Partner: a research center that is paying to promote their profile on TrialScout with the least exposure and profile page distinction. Partners cannot pay to change their star rating on TrialScout.
Non-subscriber site: a research center whose profile is based on publicly available information and have not purchased a subscription.
Department: a sub-category of a partnered research institution that focuses on a specific therapeutic area.
Reviewer: a person who has provided the least amount of identifying information to rate a research center.
Qualified Reviewer: a person who has provided a moderate amount of identifying information to rate a research center.
Authenticated Reviewer: a person who has provided the most amount of identifying information to rate a research center.