Subject expectation/ placebo response training
Placebo Response Mitigation
Reduce variability and placebo response, without reducing treatment response
Lotus’ placebo response mitigation (PRM) program is a multimedia education suite geared toward study subjects and study staff.
Its purpose is to reduce variability and placebo response, without reducing treatment response. This serves to maximize Standardized Effect Size (a measure of the signal-to-noise ratio of a clinical trial).
Lotus’ program was 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
Material is carefully customized to fit 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.
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. They implement the training without background knowledge 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/ customization of training materials during the course of a study to optimize results.
FEATURE
LOTUS
COMPETITORS
Scale-specific training around key individual study endpoints (e.g. WOMAC subscales, etc.)
Specific training to standardize Numeric Pain Rating Scale response
Specific video training on study intervention procedures (e.g. intra-articular injections, topical creams, etc.)
Continuous CRO monitoring of standardized effect size/ validation against historical data to ensure training is effective
Full-time Director, Site Methodology and support staff refining training material based on live data during study
Live presentation at investigator meeting
Video refresher courses for investigators
Recent Successes
Lotus’ PRM program was deployed in successful pivotal trials for the following recently FDA-approved drugs, among others:
International Studies
The Lotus PRM program has been translated for and used in the following countries:
- Korea
- Taiwan
- Japan
- Singapore
- Canada (Quebec/ French language)
- Denmark
And has been translated into Spanish for US Spanish speakers.
