Medical and Scientific Communications 2013 Annual Forum

The Publication Safety Writing session will present an overview of the challenges in publishing safety data for different stakeholders and audiences. Special consideration will be given to recent legislation including the Federal Food and Drug Administration Amendment Act, Risk Evaluation and Minimization Strategies (FDAAA) and the Trial and Experimental Studies Transparency (TEST) Act. These legislative acts have reformed industry’s obligation to publish safety data and biomedical journals have responded with more rigorous publishing requirements. The need for clear and concise safety writing will also be addressed from the perspective of a potentially overlooked audience. As the safety of drugs under real-life conditions will allow clinicians to make more informed decisions for patient use, the perspective of patients, families, and advocates will be discussed and their distinctive need to evaluate safety and risks as a consumer. As most safety manuscripts are based on observational and pharmacoepidemiology programs, a detailed writing approach to overcome inherent challenges will be presented, as well as the role of Safety Registries and pharmacovigilence activities mandated by health authorities. This presentation will compare and contrast the features, strengths, and limitations of drug safety information gleaned from both observational safety registries and clinical trials. Results of well-written post-approval safety manuscripts provide scientific evidence that aids in the understanding and interpretation of safety data beyond the scope of pre-approval clinical trials.