Clinical trials are necessary in drug development process.They are the most time and budget consuming in research and development process. The company that intends to conduct the clinical trials must file an Investigational New Drug (IND) application to Food and Drug Administration (FDA) to allow the investigational drug to be tested in human volunteers and the clinical trial must be carefully designed to test benefits and risks of the treatment. Every clinical trial must be led by medical doctor, researchers, and a team of nurses. To prove drug safety and effectiveness, a broader group of volunteers must be included in the clinical trial. Moreover, all IND applications must be approved by Ethics Committee of the trial sites prior to submission to FDA.

In drug discovery and research process, a great number of candidate medicines are not successfully developed to a new medicine. From the statistics, it if found that less than 12% of the candidate medicines that make it into Phase I clinical trials will be approved as a new medicine as portrayed in the below figure.

FDA Review and Approval

All imported and locally manufactured drugs must be registered with FDA. In case of new drug, the clinical trial results are important information to prove that the drug is safe and effective. Consequently, there is a great deal of documentation on information for new drug registrationFor Thailand, after submission, the FDA will have the files reviewed by experts and consider their advice prior to granting approval for such application.