Analysis of complex case-control studies in pharmacoepidemiology (P: Pharmacoepi)

• Applicant: Professor Dr. Martin Schumacher
• Subject Area: Epidemiology and Medical Biometry/Statistics
• Term: from 2004 to 2008
• Project identifier: Deutsche Forschungsgemeinschaft (DFG) - Project number 5470786

Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are rare but life-threatening disorders mainly caused by drugs. More than 100 drugs are currently suspected to cause these diseases. For assessing their risk, two international case-control studies were performed between 1989-1995 and 1997-2001. In this project, the methodological problems of such complex case-control studies with time-varying exposure will be considered. The high number of possible risk factors needs careful designed strategies in the process of model building. Changes in pattern of drug use within time and between different regions is a source of heterogeneity and may lead to complex confounding structures. Cutaneous reactions to drugs typically have a higher risk in the first few weeks of therapy than later. Implementing time varying hazard functions in the case-control design will be one issue in this project. In addition, it will be investigated whether certain drugs show an elevated risk immediately after introduction to the market. In general, the sequelae of cutaneous adverse drug reactions and their treatment shall be investigated. External data resources shall be explored.

• DFG Programme: Research Units
• Subproject of: FOR 534: Statistical Modelling and Data Analysis in Clinical Epidemiology