Whenever a company or physician (a ‘sponsor”™) wishes to assess a drug in a clinical trial, it must seek approval from the governmental departments or agencies which regulate or control new drugs in a given country or jurisdiction, such as the FDA in the US or the TGA in Australia. This process varies from country to country, but generally requires the sponsor to present a clinical study protocol, which outlines the specifics of the study, and provide scientific rational for their planned trial. These documents must show that the necessary regulatory guidelines related to clinical trials are being followed in the trial protocol.
The relevant regulatory agency will review the study protocol and scientific rationale and determine whether the study should proceed. The protocol is also reviewed to ensure it meets Good Clinical Practice or GCP standard. This complete process often requires some negotiation between the sponsor, the physicians involved in the trial, and the regulator, to reach a satisfactory conclusion. Generally this process takes 1-3 months.
During or shortly after the regulatory approval process for the study protocol, the Ethics Committees at individual study sites will reviews the protocol to ensure it meets the ethical standards of the particular institute or hospital conducting the study.