Effective Clinical Trials

NUS Academy of GxP Excellence


Course introduction

Introduction


Objective

The intent of this course is to equip technical professionals with the basic concepts in designing clinical trials and analyzing data obtained from the trials. Additionally, it will provide the fundamental knowledge in good clinical trial practice and management skills important in conducting clinical research.

Description

In this course, the principles for designing clinical trial protocol, along with the factors contributing to an effective design, will be explored. To give a better understanding on the design of effective clinical trials, the course will illustrate with some of the mechanics employed in the trials - randomization procedures and blinding treatment. Besides constructing an effective protocol, data collection and analysis is as critical and the techniques in carrying out the analysis will be discussed. In order to ensure the integrity of the research and that trial subjects are well protected, International Conference n Harmonization (ICH) Guideline for Good Clinical Practice (GCP) is created, establishing ethical and scientific standards for carrying out clinical trials. Ethics considerations involved in experiments conducting on human will be talked about in the course.

Course Outline

  • Clinical Research Design and Terminology
  • Determination of Study Duration
  • Randomization Procedures
  • Blinding Treatment
  • Study Monitoring
  • Data Analysis - Biostatistical Consideration Specific to Drug Development
  • Data Management
  • Methods for Incorporation of Biological Endpoints into Clinical Trial Design / Implementation - Multiple Endpoints
  • Regulatory Issues with Clinical Trials
  • Research Ethics

Learning Outcome

Upon completion of this course the attendees will be able to:

1. Understand the concepts and methods in designing clinical trials
2. Comprehend the different methods in analyzing data
3. Gain understanding in the ethics that is involved in effective clinical trials



Fees & Funding

Please enquire below for course fees and financial grants:


 

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