Regulatory Aspects of Clinical Trials

Safe and Successful Clinical Research

Clinical studies are the bridge between basic research and clinical application in diagnostics and therapy. Since this involves studies on and with humans, this area is extremely strictly controlled and regulated in Germany. For the six DZG, clinical trials are a focal point. The DZGs unite almost all university hospitals in Germany in their network. A large proportion of the studies conducted are multicenter.

The working group Regulatory Aspects of Clinical Trials aims to identify opportunities, but also obstacles in this process in order to make clinical research both safer and more successful. The working group therefore cooperates with the most important institutions in Germany in the regulation of clinical research, namely the Paul Ehrlich Institute, the Federal Office for Drugs and Medical Devices, the Federal Office for Radiation Protection and the Working Group of Medical Ethics Committees, an association of 52 ethics committees. The focus is on the protection of patients as well as the early inclusion of regulatory requirements in study planning and the more efficient use of data and samples.

Members of the working group
  • Carmen Brittinger (DZL)
  • Prof. Dr. Oliver Cornely (DZIF)
  • Prof. Dr. Emrah Düzel (DZNE)
  • Dr. Jan Fuge (DZL)
  • Dr. Annette Frontzek (DZNE)
  • Dr. Dr. Gerrit zur Hausen (DZL)
  • Dr. Sarah Heringer (DZIF)
  • Prof. Dr. Timo Jäger (DZIF)
  • Dr. Mahir Karakas (DZHK)
  • Dr. Monika Kraus (DZHK)
  • Dr. Norbert Krug (DZL)
  • Dr. Stephanie Lesser (DZHK)
  • Dr. Marlene Röttgen (DKTK), contact person
  • Dr. Tamara Schaprian (DZNE)
  • Prof. Dr. Peter Schwarz (DZD)
  • PD. Dr. Nicolaus Schwerk (DZL)
  • Prof. Dr. Jens Siveke (DKTK)
  • PD Dr. Olaf Sommerburg (DZL)
  • Dr. Annika Spottke (DZNE)
  • Prof. Dr. Ghazaleh Tabatabai (DKTK), spokesperson
  • Dr. Cornelius van Tilburg (DKTK)
  • Prof. Dr. Olaf Witt (DKTK)
  • Prof. Dr. Ruth Witt (DKTK)
  • Dr. Anke Witting (DZNE)
Representatives of regulatory authorities
  • Dr. Jörg Engelbergs (PEI)
  • Dr. Nadine Kirsch-Stefan (PEI)
  • Dr. Bettina Klug (PEI)
  • Dr. Nils Lilienthal (BfArM)
  • Dr. Anna Moreno (AKEK)
  • Dr. Matthias Renner (PEI)
  • Dr. Matthias Habeck (BfS)
  • Dr. Claudia Riedel (BfArM)
  • Prof. Dr. Georg Schmidt (AKEK)
  • Dr. Michael Schramm (BfArM)
  • Sabine Stemler (PEI)
  • Dr. Thomas Sudhop (BfArM)