ABSTRACT
Since 2004, adherence to Good Clinical Practice has been mandatory for all clinical drug trials. This was new to the investigator-initiated trials. Our study showed no association between the implementation of the Directive and investigator or industry-initiated trials. However, a steady decline was observed over the entire period. Presumably, the introduction of GCP did not entail a decline because of the presence of GCP units at university hospitals. Thus, researchers can conduct clinical drug trials under the same regulations as drug companies.
ABSTRACT
OBJECTIVE: To determine the impact of the European Union's Clinical Trials Directive on the number of academic drug trials carried out in Denmark. DESIGN: Retrospective review of applications for drug trials to the Danish Medicines Agency, 1993-2006. REVIEW METHODS: Applications for drug trials for alternate years were classified as academic or commercial trials. A random subset of academic trials was reviewed for number of participants in and intended monitoring of the trials. RESULTS: Academic and commercial drug trials showed an identical steady decline from 1993 to 2006 and no noticeable change after 2004 when good clinical practice became mandatory for academic trials. CONCLUSION: The Clinical Trials Directive introduced in May 2004 to ensure good clinical practice for academic drug trials was not associated with a decline in research activity in Denmark; presumably because good clinical practice units had already been in place in Danish universities since 1999. With such an infrastructure academic researchers can do drug trials under the same regulations as drug companies.
Subject(s)
Clinical Trials as Topic/statistics & numerical data , Drugs, Investigational , Investigational New Drug Application/statistics & numerical data , Denmark , European Union , Government Agencies/statistics & numerical data , Retrospective StudiesABSTRACT
According to a new EU Directive investigator initiated drug trials are to comply with the guidelines for Good Clinical Practice (GCP) as of May 2004. This implies that trials should be conducted according to a set of Standard Operating Procedures (SOPs) and be subject to monitoring and auditing. In 2001, investigators in Denmark initiated 73 drug trials. In order to provide GCP services and guidance to the investigators it is proposed to establish 3-4 regional GCP units at the three university hospitals. The estimated annual cost for the 3-4 GCP units will be between DDK 7.5 and 10 million.
Subject(s)
Clinical Trials as Topic , Research , Clinical Trials as Topic/economics , Clinical Trials as Topic/legislation & jurisprudence , Clinical Trials as Topic/standards , Denmark , Drug Monitoring/standards , European Union , Guidelines as Topic , Hospitals, University/economics , Hospitals, University/legislation & jurisprudence , Hospitals, University/standards , Humans , Informed Consent , Practice Guidelines as Topic , Research/legislation & jurisprudence , Research/standards , Research Subjects/legislation & jurisprudenceABSTRACT
INTRODUCTION: The aim of the study was to describe the pattern of admissions to a medical department and to analyse how far acute admissions can be replaced by planned subacute admissions to an outpatient department. MATERIALS AND METHODS: All acute admissions to the medical department during two six-day periods were registered. The department's registrars filled in a structured questionnaire and the senior registrars evaluated the admissions. In addition, a local general practitioner evaluated one-third of the admissions. RESULTS: Altogether, 214 consecutive patients were entered in the study. One-third of the patients had consulted their GP in the week before the admission. Admissions from the casualty department and from GPs were assessed as appropriate in 92% and 71% of the cases, respectively. The senior registrars assessed that 17-20% of the acute admissions could have been replaced by a subacute, planned admission. Only 5% of the patients shared this conclusion. The ability to predict the total length of stay was limited, and greatest accuracy was achieved in prediction of short-term stays. DISCUSSION: In a medical department with many acute admissions, it is possible to replace acute admissions with planned subacute admissions for a large group of patients.
