title: [Challenges in the organization of investigator initiated trials: in transplantation medicine].
abstract: BACKGROUND
  Transplantation medicine offers multiple translational questions which should preferably be transferred to clinical evidence. The current gold standard for testing such questions and hypotheses is by prospective randomized controlled trials (RCT). The trials should be performed independently from the medical industry to avoid conflicts of interests and to guarantee a strict scientific approach. A good model is an investigator initiated trial (IIT) in which academic institutions function as the sponsor and in which normally a scientific idea stands before marketing interests of a certain medical product.
  
  
  METHODS
  We present a model for an IIT which is sponsored and coordinated by Regensburg University Hospital at 45 sites in 13 nations (SiLVER study), highlight special pitfalls of this study and offer alternatives to this approach.
  
  
  RESULTS
  Finances: financial support in clinical trials can be obtained from the medical industry. Alternatively in Germany the Federal Ministry of Education and Research (Bundesministerium für Bildung und Forschung) offers annual grants. The expansion of financial support through foundations is desirable. Infrastructure: sponsorship within the pharmaceutics act (Arzneimittelgesetz) demands excellent infrastructural conditions and a professional team to accomplish clinical, logistic, regulatory, legal and ethical challenges in a RCT. If a large trial has sufficient financial support certain tasks can be outsourced and delegated to contract research organizations, coordinating centers for clinical trials or partners in the medical industry.
  
  
  CONCLUSIONS
  Clinical scientific advances to improve evidence are an enormous challenge when performed as an IIT. However, academic sponsors can perform (international) IITs when certain rules are followed and should be defined as the gold standard when scientific findings have to be established clinically.
authors.affiliation: Klinik und Poliklinik für Chirurgie, Universitätsklinikum Regensburg, Franz-Josef-Strauss-Allee 11, Regensburg, Germany. andreas.schnitzbauer@klinik.uni-r.de
authors.forename: A A
authors.initials: AA
authors.lastname: Schnitzbauer
authors.forename: P E
authors.initials: PE
authors.lastname: Lamby
authors.forename: I
authors.initials: I
authors.lastname: Mutzbauer
authors.forename: J
authors.initials: J
authors.lastname: von Hassel
authors.forename: E K
authors.initials: EK
authors.lastname: Geissler
authors.forename: H J
authors.initials: HJ
authors.lastname: Schlitt
mesh_terms: D016265:Conflict of Interest; D004345:Drug Industry / Q000941:ethics; D032984:Ethics, Research; D019317:Evidence-Based Medicine / Q000941:ethics / Q000458:organization & administration; D005380:Financing, Government / Q000941:ethics / Q000458:organization & administration; D005858:Germany; D006785:Hospitals, University / Q000941:ethics / Q000458:organization & administration; D006801:Humans; D040541:Marketing / Q000941:ethics / Q000458:organization & administration; D015337:Multicenter Studies as Topic / Q000941:ethics / Q000379:methods; D020416:Outsourced Services / Q000941:ethics / Q000458:organization & administration; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic / Q000941:ethics* / Q000379:methods*; D012108:Research Personnel / Q000941:ethics* / Q000458:organization & administration*; D012109:Research Support as Topic / Q000941:ethics / Q000458:organization & administration; D057170:Translational Research, Biomedical / Q000941:ethics / Q000458:organization & administration; D014180:Transplantation / Q000941:ethics* / Q000379:methods*