Dr. Pinheiro is an epidemiologist & Team Leader (Div of Epidemiology, OSE/CDER), focusing on the postmarketing eval. of neurological & psychiatric products. She is involved in multiple research projects, most aiming to investigate the postmarketing safety of neurological & psychiatric drug products.
Dr. Hammad is currently Deputy Div. Director of the Div. of Epidemiology, Office of Surveillance & Epidemiology, CDER, FDA. He has authored over 40 peer-reviewed publications and holds several academic appointments, spanning various medical disciplines.
Tianjing Li, Johns Hopkins University, United States
Dr. Cepeda is an anesthesiologist from Colombia with pain training from Mass. Gen. Hosp. & a PhD in Epidemiology from Penn Schl of Med. Main research interests are pain & evid.-based medicine. She worked in academia for many years & is currently Dir. of Epidemiology at Janssen Pharmaceutical R&D.
Dr. Pinheiro is an epidemiologist & Team Leader (Div of Epidemiology, OSE/CDER), focusing on the postmarketing eval. of neurological & psychiatric products. She is involved in multiple research projects, most aiming to investigate the postmarketing safety of neurological & psychiatric drug products.
Description
Although the value of meta-analyses in drug efficacy is established, their role in evaluating harm needs consideration. The role of meta-analyses and the reporting of methodological considerations in published meta-analyses will be discussed. The panel will also focus on additional questions such as when are these studies most useful to inform clinical and/or regulatory decision making, and what are the critical elements that should be included in a framework to assess reporting of methodological considerations of meta-analyses in drug safety?
Learning Objectives: Describe the role and the methodological limitations of meta-analysis of RCTs in drug safety Discuss the extent of reporting of critical evaluation of pertinent methodological considerations in recently published meta-analyses evaluating drug safety issues.