Regulatory, Operational, and Clinical Pharmacology Challenges of Conducting Clinical Trials in Low- and Middle-Income Countries

Session Description

Globalization of clinical trials requires that the same Good Clinical Practice (GCP) standards, and ethical principles are followed in all regions. However, conducting clinical trials in LMIC is associated with financial, regulatory, operational, clinical pharmacology and other challenges, including lack of trained study personnel. These challenges can lead to study delays, higher costs of clinical trials and limited or delayed patients’ access to medicine. International collaborations and development of health care infrastructure, including well-designed clinical pharmacology training can help address these challenges. With these ethical, regulatory, operational, and clinical pharmacology challenges properly managed, clinical research in LMIC provides historic opportunities to bring biomedical research and better healthcare infrastructure to countries previously left behind.

Learning Objectives

1. To make the ASCPT audience aware of ethical, regulatory, operational, and clinical pharmacology challenges of conducting clinical trials in low and middle income (LMIC) countries .

2. To consider what strategies can be implemented to overcome ethical, regulatory, operational, and clinical pharmacology challenges in conducting clinical trials in LMIC.

Session Schedule

Introduction
Katarina Ilic, MD, MPH, PhD and Georgios Vlasakakis, PhD

Optimizing Clinical Trials in LMIC-Regulatory Challenges
Dan Hartman, MD

The Challenges of Conducting Clinical trials in LMIC
Katarina Ilic, MD, MPH, PhD

Q&A and Closing Remarks