Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 90

The Sponsor is the “owner” of an investigational product. The sponsor is interested in studying the clinical use of investigational product to determine its pharmacological properties, safety, and/or effectiveness in humans. By definition, the sponsor is:

An individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical trial. (ICH E6(R2) 1.53)

A Sponsor can be, for example, a pharmaceutical or biotechnology company, a nongovernmental organization (NGO), a governmental agency, an academic institution, a single individual or any entity that wants to take responsibility for the initiation, management, and/or financing of a clinical trial.

The Sponsor often is the financial owner and/or the developer of the product being investigated; however, the Sponsor may simply have access to the investigational product through an agreement with the financial owner or developer. In all instances, the Sponsor does not actually conduct the investigation (i.e., administer the investigational product to research subjects and record data from the study assessments), but will be legally responsible for all handling and use of the investigational product in the trial, the integrity of the trial data collected, and the submission of the trial findings to the Regulatory Authority. A Sponsor will usually be ultimately interested in getting approval for marketing their product or for publishing new information about the product.