Before starting a pharmaceutical clinical trial, what must the clinical investigator obtain?

Before initiating a pharmaceutical clinical trial, obtaining approval from the ethics committee is essential to ensure that the rights, safety, and well-being of trial participants are protected. The ethics committee, also known as an institutional review board (IRB) in some regions, reviews the study protocol to evaluate its ethical aspects, including informed consent processes, risk management, and the scientific merit of the study.

This approval is a fundamental requirement set by regulatory authorities globally. It ensures that the trial is ethical and that participants are adequately informed about the nature of the trial, its potential risks, and benefits. The ethics committee plays a crucial role in protecting participants and maintaining public trust in the clinical research process.

While obtaining FDA approval is necessary for certain aspects of clinical trials, it is not required prior to starting a trial, as those applications occur during later phases or after initial studies have begun. The marketing authorization application is relevant after the trials confirm safety and efficacy, and the investigator's brochure provides essential information to investigators but is not an approval requirement. Thus, securing the ethics committee's approval is a key step in the process of ethical conduct in clinical research.