RX Research wants you to be aware of terminology that you may have heard during a study or a doctor may have discussed with you on a visit to one of our clinics.  Click on a term below to get a definition of that term.

• Clinical Investigator 

  • The researcher in charge of a clinical study, usually a doctor or pharmacist.  This person is the responsible leader of the team involved in conducting the study.    

• Clinical Study or Clinical Trial 

  • A carefully designed investigation into the effects of a medication, treatment or device on a group of volunteers to measure its effectiveness, safety and possible side effects.  These studies are necessary for developing new and improved treatments and making them available to the public.

• Food and Drug Administration

  • The FDA is the government agency in charge of enforcing the laws covering the manufacturing, testing and use of drugs and medical equipment.  The FDA must approve all drugs and medical equipment before being used by the public. 

• Informed Consent     

  • The FDA requires that all volunteers be made aware of the procedures, risks and benefits involved with a clinical study through discussion with the clinical investigator and/or the study staff.  The volunteer is required to sign an approved informed consent form before participating in a study. 

• Institutional Review Board (IRB)

  • A group, consisting of both healthcare professionals and members of the local community, in charge of reviewing study activities and protecting volunteer’s safety and rights.  This board must approve the study protocol as well as the informed consent form.   

• Phase I

  • A phase I clinical research trial is the evaluation of a new medication being used for the first time in humans.  These studies generally last for one year on a group of 20 - 80 healthy volunteers.  The purpose of this type of study is to determine a safe dosage range and any side effects when used by humans.

• Phase II

  • A phase II clinical research trial is designed to determine the effectiveness of the drug for a particular indication or indications in patients with the disease or condition that is being studied.  Different doses are usually studied to determine the lowest dose possible that is shown to be effective. The objective of a phase II study is to determine the common side effects and risks associated with the drug on a group of 100 to 300 volunteers.   

• Phase III

  • A phase III clinical research trial is expanded testing on the effectiveness and safety information that is needed to evaluate the overall benefit and risk relationship of the study drug and to provide an adequate basis for package labeling.  Phase III trails are also conducted on previously approved medications to test the safety and effectiveness when used for other indications or diseases that were not previously evaluated.  In this phase of the investigation, several hundred to several thousand subjects may participate over a three-month to a five-year period. 

• Phase IV

  • A phase IV clinical research trial is an extended study on post marketing medications to clarify the incidence of an adverse effect to determine the long-term effect of the drug on morbidity and mortality, or study a population not sufficiently represented in earlier trials.  Phase IV trials may also be performed to compare two or more marketed products.

• Seasonal Allergic Rhinitis

  • A collection of symptoms, predominantly in the nose and eyes, that occur after exposure to airborne particles of dust or dander or to pollens of certain seasonal plants in people that are allergic to these substances.  Allergies
    are caused by hypersensitivity of the immune system, leading to a misdirected immune response. The immune system normally protects the body against harmful substances such as bacteria, viruses, and toxins. Allergy occurs when the immune system reacts to substances (allergens) that are generally harmless and in most people do not cause an immune response.