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Press Releases

July 17, 2013

Reducing Experimental Error in Analgesic Clinical Trials

Pharmaceutical companies spend large amounts of time perfecting their protocol and selecting quality sites so that the efficacy of their drug can be statistically demonstrated in clinical trials. However, an equal amount of effort is rarely placed on other aspects of clinical trials that may lead to optimizing their success such as patient education and analgesic model manipulations. 

Neil Singla, MD, Founder & Chief Scientific Officer, Lotus Clinical Research, LLC will discuss techniques for site education, subject placebo response training and other mechanisms to mitigate variability in analgesic clinical trials. This presentation, Pain Models and Methods to Reduce Experimental Error in Analgesic Clinical Trials is just one of the highly anticipated discussions at the 7th Annual Pain Therapeutics Summit (San Diego) and the Pain Therapeutics Summit East (Boston).

According to Dr. Singla, “Subjective endpoint clinical trials, such as analgesic investigations, are vulnerable to research site level variability… Systemic reviews have shown that increasing number of trial sites can often increase the risk of study failure. Clinical studies on analgesics targeting the treatment of acute pain often fail to statistically differentiate active drugs from placebo, despite presumed efficacy of the study product in question. These type 2 errors may be secondary to decreased assay sensitivity in the multicenter environment for subjective endpoint clinical trials.”

Endpoints in pain clinical trials is one of the key themes of the 7th Annual Pain Therapeutics Summit. The event will explore a variety of topics affecting the field of pain research and drug development with the goal of bringing together industry, academic and government leaders to discuss novel research and key field developments.

Dr. Singla will present at both the East and West Coast Pain Therapeutics Summits. The East Coast Summit will take place in Boston, MA on September 25 -26 at the Doubletree Suites Boston-Cambridge and the West Coast Summit will be held in San Diego, CA on November 7-8 at the Embassy Suites San Diego Bay – Downtown. For more information on these events please visit: www.paintherapeuticsummit.com and www.paintherapeuticsummiteast.com

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