Who conducts a clinical trial?

There are many different people involved with conducting clinical trials, with each person responsible for doing their part to ensure the completion of a safe and efficient study.  Some of the positions include the following:

• Principal Investigator (PI)
• Responsible for the conduct of the clinical trial at the study site
• Assumes overall responsibility for the management of the study
• Assigns responsibilities for other members of the team
• Ensures that informed consent is properly obtained from the study volunteers
• Serves as the liaison for major patient care issues with the sponsor and the institutional review board (IRB), an oversight committee, and ensures that the IRB is informed of all safety issues
• Makes medical assessments, evaluating the efficacy of the study medication and whether adverse events are study related or not
• Ensures the accuracy of the data that are submitted
• Subinvestigators
• Assume the responsibility for patient care assessments
• Less likely to be saddled with the administrative responsibilities of the PI
• Clinical Research Coordinator or Study Coordinator
• In charge of managing the individual study site
• Helps assess study feasibility
• Handles, prepares and tracks document submission
• Manages the day-to-day logistics of everything

Who else is involved in a clinical trial?

• Subjects
• Trial participants
• Also referred to as patients or volunteers
• Institutional Review Board (IRB)
• Committee designated to review the participation of subjects in research studies
• Oversees the regulatory, ethical and safety aspects of a trial at the individual study site
• Decides what constitutes informed consent
• Food and Drug Administration (FDA)
• Department of the U.S. government
• Provides regulatory oversight for the pharmaceutical industry
• Provides assurances to the public for the quality and safety of all the drugs dispensed in the U.S.
• Sponsors
• Pharmaceutical company (drug company)
• Group who controls the finances
• Develops the drug, overseeing its growth from initial identification of the chemical entity through manufacturing and testing of the product in people.
• Provides management of the trial
• Designs the trial
• Provides materials
• Collects data
• Monitors the trial
• Audits all procedures and data submitted to support the application for approval from the government
• Keep investigators informed of new information about the trial drug

The sponsor's team may include the following positions:

• Clinical Research Associate (CRA)
• Often referred to as the monitor
• Acts as an agent of the drug company
• Monitor how the trial is being conducted at the study sites
• Medical Research Associate (MRA)
• Functions like a CRA, but is in-house at the sponsor's facility
• Medical Monitor
• Physician on call for protocol questions or safety issues
• Ideally, knows something about the investigational area in question
• Should be willing to learn on the job

Information taken from "Conducting Clinical Research" by Judy Stone, M.D. Copyright 2006.