This research project is designed to assist the U.S. Food and Drug Administration Center for DrugEvaluation and Research's (FDA/CDER's) Office of Communications in meeting the challenges ofcommunicating scientific information to the public, especially about prescription drugs and over-the-countermedications. FDA has already undertaken several activities to enhance its communication strategies to thepublic about the risks and benefits of the products it regulates. Our research will focus on understanding howadults in the United States may differ with respect to health literacy skills and examine how health literacyand other consumer characteristics may impact the effectiveness of FDA communications. In addition, wewill explore and then evaluate how messages and products can be modified to meet the needs of variousaudience segments. We address the following research questions: (1) What factors influence people'scomprehension of medication risk and benefit information and drug-related decisions? (2) What role does themedia play in communicating scientific data about medications to the public? (3) Does targeting messagesand materials to certain audience segments improve the transmission of scientific information and promoteinformed decision making? Aim 1 includes conducting a web-based panel survey of 1,300 U.S.noninstitutionalized adults aged 18 to 74 years and then developing audience segments relevant to CDER.
Aim 2 contains three simultaneous activities: (a) performing content analysis and media monitoring, (b)conducting formative research with new audience segments, and (c) assessing current FDA outreach anddissemination strategies relative to the CDER Strategic Plan and FDA Strategic Plan for RiskCommunication.
In Aim 3, we will share findings from Aims 1 and 2 with the FDA/CDER/Office ofCommunications and then collaborate to develop, implement, and evaluate a pilot study. The pilot study willprovide these newly identified audience segments with information about FDA products to help promotemore informed decisions about drug safety, medication choices, and adherence. Our expected outcomesfrom this project are (1) the development of a more nuanced understanding and approach to developingscientific communication about medications, (2) enhanced capacity within CDER for developingcommunication tools and services that meet the information needs of most U.S. adults, and (3)understanding of how this knowledge can be used to create campaigns through traditional and new mediachannels.

Public Health Relevance

In this research project, we focus on understanding how health literacy and other characteristics may influence the effectiveness of FDA communications in achieving public health objectives. In addition, we explore and evaluate how messages about prescription and over-the-counter medications can be modified to meet the needs of various audience segments and promote informed decision making.

National Institute of Health (NIH)
Food and Drug Administration (FDA)
Research Demonstration--Cooperative Agreements (U18)
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Special Emphasis Panel (ZFD1-SRC (99))
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Research Triangle Institute
Research Triangle
United States
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