Schnitzbauer, A. A. and Lamby, P. E. and Mutzbauer, I. and von Hassel, J. and Geissler, E. K. and Schlitt, H. J. (2011) Challenges in the organization of investigator initiated trials. In transplantation medicine. CHIRURG, 82 (3). pp. 249-254. ISSN 0009-4722
Full text not available from this repository. (Request a copy)Abstract
Transplantation medicine offers multiple translational questions which should preferably be transfered 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 aproach. 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. 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. Finances: financial support in clinical trials can be obtained from the medical industry. Alternatively in Germany the Federal Ministry of Education and Research (Bundesministerium fur 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. 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.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | SOLID-ORGAN TRANSPLANTATION; CLINICAL RENAL TRANSPLANTATION; LONG-TERM SURVIVAL; LIVER-TRANSPLANTATION; HEPATOCELLULAR-CARCINOMA; CANCER INCIDENCE; RISK-FACTORS; IMMUNOSUPPRESSION; MALIGNANCY; RECURRENCE; Evidence-based medicine; Prospective randomized controlled trial; Financial management; Translational science; Investigator initiated trials |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Chirurgie |
| Depositing User: | Petra Gürster |
| Date Deposited: | 28 Apr 2020 10:23 |
| Last Modified: | 28 Apr 2020 10:23 |
| URI: | https://pred.uni-regensburg.de/id/eprint/21177 |
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