Importance to FDA

Application of social and behavioral science (SBS) research is intended to provide patients and consumers with appropriate information to help them make decisions about the use of FDA-regulated products. SBS research guides the development of evidence-based messaging and information; evaluates the impact of communication and educational materials; and strives to understand beliefs and attitudes of diverse patient and consumer audiences.

Developing clear, science-based communications empowers patients, healthcare professionals, and consumers to make the best decisions possible about FDA-regulated products. To develop communications that are relevant, culturally appropriate, and meet the patients’ and consumers’ health literacy needs, FDA designs SBS research studies that provide an understanding of patients’ and consumers’ beliefs, attitudes, feelings, and motivations related to various public health topics.

Examples

FDA implements a variety of social and behavioral science research approaches.

• Using patient and consumer interviews and surveys to determine how messaging, labeling statements, and claims related to a medicine’s attributes, food consumption and cosmetic usage affect patients’ and consumers’ understanding and decision-making.
• Examining tobacco-related beliefs and perceptions held by subgroups (e.g., representing ethnically diverse populations) to improve our communication strategies and develop innovative public education campaigns aimed at preventing and reducing tobacco use across diverse populations (e.g., The Real Cost Campaign).
• Conducting extensive formative research, including more than 40 focus groups, representing the diverse backgrounds of consumers around the United States, to produce consumer-oriented educational materials for the Feed Your Mind Initiative. This agricultural biotechnology initiative provides consumers with science-based educational information informed by the latest science and research studies on the environmental, nutritional, food safety, economic, and humanitarian impacts of genetically engineered or bioengineered foods, commonly called genetically modified organisms.
• Using data from social media posts (e.g., Facebook and Twitter), and FDA archival data (e.g., FDA’s Advisory Committee transcripts) to better understand patient and consumer perspectives. for all FDA-regulated commodities.
• Evaluating different ways to assess the patient experience that complement existing survival and tumor information typically included in oncology clinical trials. FDA’s Project Patient Voice website communicates and summarizes PRO data submitted in regulatory applications by some drug sponsors. As part of this effort, FDA is supporting research into analytic and visualization methods to communicate accurate and non-misleading symptom and functional data from clinical trials to aid in clinical decision-making for patients and providers.