INTRODUCTION
There is an increasing need for highly qualified clinical investigators, defined as those participating in patient-oriented, translational, epidemiologic, behavioral, outcomes or health services research. The objective of this course is to provide training for the next generation of healthcare workers in the clinical research arena, providing a platform for more enhanced efficiencies in the translation of medical discoveries into clinical practice.
PROGRAM OBJECTIVES
- Learning the methods required to perform both observational and experimental clinical research
- Planning and implementing clinical research projects
- Analyzing interpreting and presenting clinical research data
- Learning the basic epidemiologic methods involved in clinical research
- Discussing the principles involved in the ethics of clinical research
- Learning the legal issues involved in clinical research
- Knowing about the regulations involved in human subjects research
- Being familiar with the role of institutional review boards (IRBs) in clinical research
- Becoming familiar with the principles and issues involved in monitoring patient-oriented research
- Being able to discuss the infrastructure required in performing clinical research
- Understanding the steps involved in developing and funding research studies
WHO SHOULD ATTEND?
- Practicing physicians
- Junior faculty in clinical departments
- Residents
- Academicians
- Industry and hospital based researchers
- Those who are interested in the conduct, interpretation and implementation of clinical research
- Those who seek to improve the delivery of high quality care and health care policies
PROGRAM OUTLINE
- Statistical Methods, Research and Regulatory Issues
- Design of Epidemiologic Studies
- Issues in Randomization
- Measures
- Participant Selection
- Overview of Hypothesis Testing
- Secondary Data/Meta Analysis
- Sample Size and Power
- Conceptual Approach to Survival Analysis
- Study Development
- Designing and Testing Questionnaires
- Efficient Clinical Trials
- Research with Vulnerable Participants
- Ethical Principles in Clinical Research
- Ethical Issues and Regulation of Human Subjects Research
- Legal Issues in Clinical Research
- Concepts in the Management of Projects
- Evaluation of a Protocol Budget
- Human Genome Project and Clinical Research
- Data and Safety Monitoring Boards
- The Clinical Researcher and the Media
- Product Development: Moving from the Bench to the Clinic
- FDA Product Regulation
- Monitoring Patient-Oriented Research and Regulatory Issues
- Data Management in Clinical Trials
- Information Resources for Clinical Research
- Quality of Life
- Scientific Conduct
- NIH Peer Review Process
- Preparing and Funding a Clinical Research Study- Part I
- Quality Control in Clinical Trials
- Clinical Research from the Patient's Perspective
- Design of Case Report Forms
- ProtoType and Protocol Mechanics
- Preparing and Funding a Clinical Research Study- Part II
- Technology Transfer
- Inclusion of Women and Minorities in Clinical Trials
- Evaluation of Alternative and Complementary Therapies
- Health Disparities Research
- Community-Based Participatory Research
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