Signals and Noise in Drug Safety Analyses:: The incretin therapy debate provides the rationale for revamping epidemiologic pharmacovigilance

• Autores: William T. Cefalu, Julio Rosenstock, Robert R. Henry, Matthew C Riddle
• Localización: Diabetes care, ISSN-e 0149-5992, Vol. 36, Nº. 7, 2013, págs. 1804-1806
• Idioma: inglés
• Texto completo no disponible (Saber más ...)
• Resumen

  • At present, we feel it is our charge to bring to the forefront another contentious topic that directly concerns the care of people with diabetes: the ongoing debate on the risks versus benefits of incretin-based therapies. [...]in this issue we present four articles providing background material and specific arguments on this controversy. Methodologie disputes about ways to measure medical outcomes, identify trends, and assess statistical relevance are common and lead to difficulties for clinical researchers, regulatory agencies, practicing physicians, and patients alike. [...]it is important to understand the complexities of assessing new or current products in regard to both benefits and risks.