Category: Fellows Posters
Pharmaceutical companies develop scientific response letters (SRLs) as a response to healthcare providers (HCPs) unsolicited requests for off-label information. Although there are requirements mandated by the Food and Drug Administration for these queries, there is still a lack of best practice standard operating procedures (SOPs) utilized by the industry. HCPs have been surveyed to identify key characteristics of SRLs that would be important for making clinical decisions. The objective of this study is to adapt a rubric from surveyed data and use it to evaluate SRLs with the goal of increasing clinical transparency.
This study will be an evaluative analysis of SRLs. Pharmaceutical companies that are identified as a top 50 company will be included. Companies without a U.S. medical information (MI) department will be excluded. This study will be conducted in three parts. First, a rubric will be developed based on current literature of HCPs preferences for SRLs. Components of the rubric will include evidence of balanced content, use of peer-reviewed literature, and tables and charts to represent available data. Second, SRLs will be collected via company MI online databases or by request as a medical information inquiry. Third, the SRLs efficacy, safety, and overall availability of clinical data will be assessed using the rubric. Following that, an evaluation on percent compliant will be performed. Based on the assessment of the SRLs, the rubric will be modified to improve SRL practices and serve as a tool for standardization.