The Department of Clinical Pharmacology and Pharmacoepidemiology would like to introduce itself
Understanding variability is understanding life. More than 40 years after its establishment in 1968 as one of the first clinical pharmacology units in Germany (and Europe), the Department of Clinical Pharmacology and Pharmacoepidemiology at the Heidelberg University has become a multidisciplinary research group dealing with all aspects of the variability of beneficial and adverse drug actions. Being part of the Section Internal Medicine it is closely linked to all the other departments of the Heidelberg University Hospital and to the major research institutions on campus. In addition, together with the Pharmacy Department of the Heidelberg University Hospital and the University's Institute of Pharmacy and Molecular Biotechnology, in 2005, the Department has jointly established the Cooperation Unit Clinical Pharmacy that links medical and pharmaceutical sciences for the sake of research and teaching.
The Department of Clinical Pharmacoloy and Pharmacoepidemiology focuses its research activities on two areas of pharmacological translation:
The first step is the translation of basic science knowledge into the development of investigational new drugs, i.e. a bench-to-bedside approach at the interface between basic science and clinical medicine. For this purpose, the Department runs a frist-in-man (FIM) facility experienced in the conduct of phase 0 and phase I trials with small molecules and biologicals in patients and healthy volunteers. A mass spectrometry center performs the ultrasensitive quantification of drugs and their metabolites in any given biological matrix and thus supports pharmacokinetic and pharmacodynamic assessment. To facilitate the research in this area, the Department has established the FIM-Heidelberg consortium, an interdisciplinary research group combining highly qualified partners of the Medical Faculty, the University Hospital, and the German Cancer Research Center (DKFZ). FIM-Heidelberg efficiently brings translational research projects into the hospital and offers a comprehensive service for the implementation of the first exposure (First in Man) and proof-of-principle-studies with innovative drugs under highest safety and quality standards. It is specialized in the planning, the conduct, and the analysis/evaluation of early clinical studies with particular emphasis on hematological, oncological, rheumatological, or immunological diseases and targets.
The second step is the translation of the clinical study results into everyday clinical practice and health decision making as a targeted intervention to bridge the efficacy-effectiveness gap. The Department is thus concerned with modulators of drug efficacy and effectiveness, and drug safety. Special attention is paid to the methods of individualization of drug therapies customized to the specific needs of the individual patient, and the measures to increase the effectiveness of both drug prescription and application. For this purpose, the Department maintains a large knowledge basis (e.g. on drug interactions and dosing in renal failure (www.dosing.de)) and conducts clinical trials assessing drug elimination and the impact of timing and genetics on drug inteactions. Moreover, it develops and evaluates electronic techniques of knowledge transfer (e.g. electronic expert systems guiding dose individualization, immediate feedback strategies for the early diagnosis of risk situations) and runs a web-based computerized physician order entry system (AiDKlinik®) to prevent medication errors at the point of care.
Hence, in a certified environment according to ISO9001:2008, the Department provides optimum conditions to develop electronic tools for health professionals, to conduct early phase trials requiring unlimited access to tertiary care infrastructure, and for patient recruitment for drug trials. Its main emphasis is put on four areas of interest: (1) FIM studies with small molecules and biologicals, (2) drug-drug interactions (with particular regard to timing and genetics of CYP and active drug uptake and efflux transporters) analysed in clinical studies and in vitro, (3) techniques to assess the drug treatment process, detect medication errors, and increase drug safety, and (4) the development of electronic drug information and expert systems for the prevention of medication errors and the individualization of all relevant aspects of drug treatment.