Placebo Response Mitigation

Reduce variability and placebo response, without reducing treatment response

Lotus’ placebo response mitigation (PRM) program is a multimedia education suite designed for both study subjects and study staff.

The purpose of the program is to reduce variability and placebo response, without diminishing treatment response. This serves to maximize Standardized Effect Size (a measure of the signal-to-noise ratio of a clinical trial).

Lotus’ program was the first such training brought to market and has been successfully deployed in over 50 studies to date. It includes:

  • Video training for study subjects and investigators
  • Written comprehension tests
  • Live investigator meeting presentations

The material is carefully customized to align with the specifics of each client’s protocol.

The PRM program is a core integrated offering of Lotus’ CRO services, and is deployed on every placebo-controlled trial run by Lotus CRO. PRM is also offered as a standalone service.

Placebo Response Mitigation Training - Overview

Advantages

While competing training suites have been developed, Lotus PRM remains the industry standard and the most widely deployed program of its kind.

Competing CROs without expertise in CNS typically license their placebo response training programs from an outside vendor and implement the training without a full understanding of how or why it works.

With Lotus PRM, the same team responsible for creating and refining our materials implements the training. Integration with our CRO offering enables continuous monitoring and data-driven adjustment or customization of training materials during the course of a study to optimize results.

FEATURE
LOTUS
COMPETITORS
Subject expectation/ placebo response training
Scale-specific training around key individual study endpoints (e.g. WOMAC subscales, etc.)
Specific training to standardize Numeric Pain Rating Scale response
Continuous CRO monitoring of standardized effect size/ validation against historical data to ensure training is effective
Specific video training on study intervention procedures (e.g. intra-articular injections, topical creams, etc.)
Full-time Director, Site Methodology and support staff refining training material based on live data during study

Video refresher courses for investigators

Live presentation at investigator meeting

Recent Successes

Lotus’ PRM program has been deployed in successful pivotal trials for the following recently FDA-approved drugs, among others:

Olinvyk
Anjeso
Zynrelef

International Studies

The Lotus PRM program has been translated and used in the following countries:
  • France
  • Czech Republic
  • Germany
  • Poland
  • Mexico
  • China
  • Korea
  • Taiwan
  • Japan
  • Singapore
  • Canada (Quebec/ French language)
  • Denmark
And has been translated into Spanish for U.S. Spanish speakers.