Methodological characteristics of academic clinical drug trials--a retrospective cohort study of applications to the Danish Medicines Agency 1993-2005.

Aim: The aim of this study was to investigate the temporal trends in characteristics of academic clinical drug trials. We here report characteristics on trial methodology.

Methods: A review of 386 approved applications of academic clinical drug trials submitted to the Danish Medicines Agency 1993-2005 was carried out.

[Effect of the GCP Directive on academic drug trials].

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.

Effect of European Clinical Trials Directive on academic drug trials in Denmark: retrospective study of applications to the Danish Medicines Agency 1993-2006.

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.

[How to establish GCP-units in Denmark?].

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.

[Can emergency admissions to departments of internal medicine be replaced by planned admissions?].

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.