Patient-Centered Drug Development and Real-World Evidence/Data Program

The Georgia Clinical & Translational Science Alliance- Georgia CTSA and Southern California Clinical and Translational Science Institute -SC-CTSI have collaborated to provide free, high quality educational programs for clinical research professionals at novice to expert levels of experience. At the completion of each course or program, participants earn contact hours recognized by a certificate and/or badge.

Program Description:

This five-course program provides an overview of real-world data (RWD) and real-world evidence (RWE). Collected through the routine delivery of health care, RWD and RWE are potentially powerful tools for enhancing the quality and efficiency of clinical trials and precision medicine.

Traditionally, data from randomized clinical trial have been viewed as the gold standard in drug development.  Over the last decade, new sources of data and innovative technologies have accelerated the shift toward individualized care and precision medicine, whereby providers can develop treatment plans targeted to specific patient needs and improved outcomes.  Made possible by a number of U.S. Food and Drug Administration acts and developments, regulators and pharmaceutical developers have begun to view real-world data (RWD)/real-world evidence (RWE) as a more efficient way to evaluate drug approval and label expansion decisions.

In this program, the concepts and development of RWD/RWE will be explored, including its usefulness in rare diseases, insights and challenges in data validity, and how RWD/RWE can accelerate clinical trials and the integration of precision medicine within standardized care.

Goal:

At the end of this program, participants will understand the concept of patient-focused drug development and how real-world data and real-world evidence are applied to evaluation of rare diseases and the field of oncology, and how tools are developed in transforming data to applicable information to knowledge. 

Course Topics in this Program:

• Session 1: History, Terms and Definitions
• Session 2: Patient-Centered Drug Development
• Session 3: Introduction to Rare Diseases and Orphan Drugs
• Session 4: From Data, to Information, to Knowledge
• Session 5: Case Study – From Discovery to Practice and Survivorship

Learner Level: Intermediate/Advanced

Audience:

This program is designed for Clinical Research Coordinators, Project Managers, Monitors, Regulatory, Medical and Clinical Affairs Professionals or junior faculty with 3+ years of experience seeking to further develop clinical research conduct skills and principles.  Clinical research professionals should have responsibilities that include clinical trial start up planning, mentoring and complex issues involving site management, study management, and sponsor/ CRO challenges.