Implementing Good Clinical Practice in two noncommercial phase II studies in children with cancer.
BACKGROUND
In noncommercial clinical drug research the implementation of the principles of Good Clinical Practice (GCP) has been criticized for introducing unnecessary bureaucracy at the expense of scientific activity, especially when small populations such as children or patients with orphan diseases are concerned.


METHODS
From May 2003 to September 2005, we conducted two prospective open-label multicenter phase II studies in pediatric oncology. Aside from medical questions, these studies set out to explore the requirements according to the essential standards of the ICH-GCP Guideline in anticipation of the implementation of the EU Regulation in German Drug Law in August 2004; the latter, prospective investigation was initiated by the Coordinating Center for Clinical Trials (KKS).


RESULTS
The main GCP requirements were systematically reviewed and critically discussed by focusing mainly on the situation of noncommercial pediatric drug research.


CONCLUSIONS
While putting GCP into practice in academic research increases costs, the challenge will be to apply these guidelines to good effect, for better quality and increased evidence.
Wagner-Bohn
Alexandra
A
Coordinating Centre for Clinical Trials, University Hospital of Münster, Germany. bohna@gmx.de
Ripkens-Reinhard
Anita
A
Benninger-Döring
Gerlinde
G
Boos
Joachim
J
D002648:Child; D017322:Clinical Trials, Phase II as Topic / Q000592:standards*; D003841:Deoxycytidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005062:European Union; D005380:Financing, Government / Q000458:organization & administration; D005858:Germany; D006801:Humans; D007258:Informed Consent; D008495:Medical Oncology / Q000592:standards*; D009369:Neoplasms / Q000188:drug therapy*; D010372:Pediatrics / Q000592:standards*; D017410:Practice Guidelines as Topic; D010818:Practice Patterns, Physicians' / Q000592:standards*; D000093542:Gemcitabine
D003841:Deoxycytidine; D000093542:Gemcitabine