Lene Grejs Petersen

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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(More)
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. Data on 11 methodological(More)
BACKGROUND Unacknowledged inconsistencies in the reporting of clinical trials undermine the validity of the results of the trials. Little is known about inconsistency in the reporting of academic clinical drug trials. Therefore, we investigated the prevalence of consistency between protocols and published reports of academic clinical drug trials. METHODS(More)
OBJECTIVE To characterize and quantify barriers towards the publication of academic drug trials. STUDY DESIGN We identified academic drug trials approved during a 3-year period (2004-2007) by the Danish Medicines Agency. We conducted a survey among the trial sponsors to describe the rates of initiation, completion, and publication, and the reasons for the(More)
A strategy in heart disease prevention at worksites was developed based on target group analysis on determinants of health behavior among Danish men. The target group analysis provided information on credibility problems and negative attitudes toward health education. Men operate with more knowledge types and direct their health behavior toward experiential(More)
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(More)