GCP & Regulatory Affairs
The Good Clinical Practice & Regulatory Affairs Facility supports scientists and clinicians in the preparation, implementation, and conduction of clinical trials.
The Good Clinical Practice (GCP) & Regulatory Affairs team supports the Institute’s researchers and clinicians in the preparation, implementation and conduction of clinical studies. The team closely cooperates with the Department for Internal Medicine III (Hematology & Oncology) and the Early Clinical Trial Unit (ECTU) at the University Hospital Regensburg (UKR).
LIT scientists develop new immune cell therapies for the treatment of cancer and transplant patients, as well as for patients with autoimmune and chronic inflammatory diseases. Such new treatment strategies must be tested in early clinical trials. These trials are conducted in accordance with GCP rules and regulations as well as international ethical and scientific standards. Compliance with these standards in trial design and conduction ensures that the rights, safety and well-being of study participants are respected, as outlined in the Declaration of Helsinki and other directives.
What is a clinical study?
After the successful testing of novel therapies in preclinical models, promising strategies are finally tested in humans. In a stepwise fashion, new treatments are tested in patients to evaluate their feasibility, safety and therapeutic efficacy. Only after successful completion of such trials can a new treatment be licensed for routine clinical use.
What we do.
The GCP & Regulatory Affairs Team provides the infrastructure and expertise for the preparation and conduction of clinical studies. It supports preclinical and clinical scientists early on in the trial preparation phase to ensure a smooth transition. The team fosters cooperations between scientists, clinical researchers, physicians, biostatisticians, study nurses, and other healthcare professionals. It closely interacts with the Department for Internal Medicine III, the Early Clinical Trial Unit (ECTU), and the Center for Clinical Studies (ZKS) at the University Hospital of Regensburg. Another key collaboration partner is the José-Carreras-Center (JCC), where the cell therapy products are manufactured.
What this offers patients.
Novel cell therapies offer treatment options for patients with otherwise incurable diseases. Clinical trials permit early access to innovative therapies and advance the field as a whole—thereby improving treatments also for future patients.
More information and contact:
Professor Matthias Edinger
Director of JCC & Head of Research Group | Immunoregulation
Email: matthias.edinger@ukr.de
Professor Simone Thomas
Head of Research Group | T-Cell Therapy
Email: simone.thomas@ukr.de