2023 Conference Agenda
Wednesday, October 18, 2023
Pre-Conference Workshop
Placebo Response Mitigation in Pain Clinical Trials
Placebo-controlled clinical trials with primary endpoints based on subjective measures suffer from a high degree of variability secondary to inflated placebo response and inaccurate patient reporting. This is especially problematic in analgesic studies, where formulations of drugs known to work often fail to separate from placebo in clinical trials. Dr. Singla will discuss a placebo response mitigation strategy he has deployed in over 50 analgesic clinical trials, designed to mitigate both placebo response among subjects and study bias among investigators. He'll provide a detailed overview of this material, share insights from 10 years of refining the program, and lead an interactive workshop where researchers and drug developers can test their own knowledge about investigator bias in clinical trials.
Learning Objectives
After this session attendees will:
1. Understand how and why placebo response and other sources of data variability can cause false negative results in clinical trials.
2. Have access to a series of potential techniques to employ in clinical trials that may reduce bias from study staff and study subjects, and produce more accurate data
Neil Singla, MD, Chief Scientific Officer, Lotus Clinical Research
Dr. Neil Singla, a board-certified anesthesiologist, is the founder and Chief Scientific Officer of Lotus Clinical Research. Since its inception in 2001, Dr. Singla has served in several roles within the organization including: Research Coordinator, Sub-Investigator, Principal Investigator, Coordinating Investigator, and Chief Scientific Officer.
In his capacity as CSO for Lotus Clinical Research, Dr. Singla has had the opportunity to interact frequently with the FDA’s Analgesics Division on behalf of clients and to play a significant role in guiding development strategies for dozens of putative analgesic agents. In the company’s 18-year history, Dr. Singla and Lotus Clinical Research have played a significant role in bringing several molecules to market.
Dr. Singla has published extensively and is a frequent lecturer for physicians, pharmaceutical companies, and medical research institutes throughout the country. He currently chairs the Analgesic Clinical Trials Shared/Special Interest Group at the International Association for the Study of Pain (IASP), chaired the Clinical Trials Shared Interest Group at the American Pain Society (APS) through 2019, chairs the annual Conference on Analgesic Clinical Trials, which aims to help experts advance best practices in analgesic drug development, as well as, serving on the Clinical Research Committee at Huntington Hospital.
The main focus of Dr. Singla’s academic endeavors has been to analyze and understand how the inherent variability in subjective endpoint analgesic clinical trials can be minimized. As a result, he has developed novel techniques for patient education designed to minimize variability, reduce placebo response, and increase effect size.
