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RTI Health Solutions Experts Contribute to FDA Workshop on REMS Assessments Methods
posted 2012.11.13

Research Triangle Park NC - Research scientists from RTI Health Solutions (RTI-HS) participated in an FDA workshop to discuss REMS assessments methods. The public workshop titled "Risk Evaluation and Mitigation Strategy Assessments: Social Science Methodologies to Assess Goals Related to Knowledge" was designed to share information and promote dialogue about best practices to evaluate the effectiveness of REMS programs. The FDA indicated a goal of the workshop was to use input to develop guidance for industry describing best practices for conducting REMS assessments.

As part of their contribution the RTI-HS researchers summarized their discussion in a white paper titled "Risk Evaluation and Mitigation Strategy Assessments: Social Science Methodologies to Assess Goals Related to Knowledge." The paper is archived on the FDA Docket:

http://www.regulations.gov/#!documentDetail;D=FDA-2012-N-0408-0024

Alicia Gilsenan, Senior Director, Epidemiology, served as a panel member for both panel sessions and her colleagues Kelly Hollis, Global Head, Surveys and Observational Studies, Sandy Lewis, Director of Patient-Reported Outcomes, and Laurie Zografos, Senior Director, Surveys and Observational Studies, presented on the following best practices in survey methodology to minimize bias:

  1. Cognitive testing in the development of survey instruments to assure questions and response choices are well understood by potential study participants;
  2. Comparing the characteristics of survey responders to non-responders and to the target population, to evaluate potential differences that might suggest the respondents are not representative of the target population and
  3. Considerations in the establishment of knowledge thresholds to determine a REMS program's success. Establishment of a single arbitrary threshold may be inappropriate in many cases, where results from knowledge and behavior surveys should be evaluated with consideration for the characteristics of the population as well as alongside other evidence, such as drug utilization patterns that can evaluate the effectiveness of a REMS program.

For more information contact:

Alicia Gilsenan
Senior Director, Epidemiology
Email: agilsenan@rti.org

Or

Kelly Hollis
Global Head, Surveys and Observational Studies
Email: khollis@rti.org

About RTI Health Solutions:
RTI Health Solutions provide scientifically rigorous research and consulting services to pharmaceutical, biotechnology and medical device companies.

 

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