Improving Quality of Clinical Trials and Addressing Subjects’ Protection by Encouraging Research and Development of New Drugs 【Date:2018-10-31】

  • Resource: TFDA
  • Release date: 11/6/2018 4:14:11 PM

Along with encouraging innovation in new drugdevelopment Taiwan Food and Drug Administration (TFDA) places a highimportance on ensuring and protecting the rights of those patientsinvolved in clinical trials. In order to achieve this TFDA promote aclinical trial training program to ensure compliance with Guidelinesfor Good Clinical Practice and address the spirit of the InternationalCouncil for Harmonization of Technical Requirements for Pharmaceuticalsfor Human Use (ICH). In addition, TFDA has also revised Informed Consent Form template and addressedsubjects’ protection ensuring their rights and providing clearinformation to promote awareness regarding the trial.

The TFDA also supports theclinical trial training program yearly which consists of two types oftraining courses, which are the basic training and the advancedtraining. The basic training courses focus on fundamental conceptsincluding Good Clinical Practice, research ethics, and quality oftrials. The advanced training courses focus on further learning anddiscussion for specific topics, such as “Early Phase Clinical Trial forDrug Development” and “the Implementation of Monitoring ClinicalTrials”. The subjects’ protection activities focus on the correctconcepts for clinical trials as well as the rights and responsibilitiesof the subjects. The approaches include lessons and adventure games tointroduce basic concepts of clinical trials to the publics.

In the future, TFDA plans to establish anonline learning system for helping more people understand clinicaltrials and the rights of those involved. In the meantime, TFDA willcontinue to perfect the environment of clinical trials and strengthenthe protection of subjects.