Clinical Trials Overview

What is a clinical trial?

A clinical trial is a type of research study that investigates the safety and effectiveness of a test article, such as a new treatment, on individuals. New drugs or devices are tested on humans only after they are found to be safe and effective in both test tube and animal studies. In the United States clinical trials must be conducted in compliance with FDA regulations before drugs or devices are made available to the public. There are four main phases of clinical trials see www.clinicaltrials.gov

Definitions:

Research

A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

Subject

A subject is the individual who participates in research. A subject can be either a healthy volunteer or a patient.

Sponsor

The sponsor is a person or entity that initiates a clinical investigation of a drug. It is usually the drug or device manufacturer or research institution that developed the drug or device. The sponsor initiates, funds, or is responsible for a research study. The sponsor assumes responsibility for compliance with applicable laws and regulations. The sponsor, for example, is responsible for obtaining FDA approval to conduct a trial and for reporting the results of the trial to the FDA.

Investigator or Principal Investigator

The investigator is the individual who is responsible for the proper conduct of the clinical trial at the trial site. If a team of individuals conducts a trial, the lead investigator may be called the principal investigator. The principal investigator may also be called the study doctor.

Informed Consent Document

The informed consent is a document that describes the clinical trial. It includes the purpose, duration, procedures, risks, benefits, alternative treatments, costs, confidentiality and trial withdrawal information. The informed consent document is reviewed and approved by the IRB before it is used to enroll an individual in a clinical trial.

IRB

Institutional Review Board; a committee designated by an institution to review, approve and monitor research involving human subjects. The primary purpose of an IRB is to assure the protection of the rights of human subjects. IRBs are composed of a diverse group and can include doctors, lawyers, nurses, pharmacists, and members of the local community. Federal regulations that govern clinical trials require that an IRB must review and approve all clinical research studies before they can start, and must conduct ongoing reviews of clinical research studies.

What is the FDA and/or OHRP?

FDA is the abbreviation for the Food and Drug Administration, part of the U.S. Department of Health and Human Services (HHS). The FDA is the United States government agency responsible for regulating clinical research submitted in marketing applications for food, drugs, medical devices and cosmetics in the United States.

OHRP – The Office for Human Research Protections (OHRP),part of the U.S. Department of Health and Human Service (HHS), establishes criteria for compliance with the HHS policy for protection of human subjects in research conducted or supported by many federal agencies. Institutions engaged in human subject research must sign an Assurance, indicating their agreement to comply with the OHRP’s regulations, in order to receive federal support for research.