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Aim: To evaluate older gynecologic oncology patients' quality of life (QOL) at the initiation of chemotherapy and compare their QOL scores with a female age‐matched general population (GP) sample. Design: Cross‐sectional. Methods: Older (n = 122) gynecologic oncology patients completed the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (QLQ‐C30) that evaluates global health and five functional scales (range from 0 to 100). Differences in QOL scores between our sample and the GP were evaluated using one‐sample t‐tests and effect sizes were calculated using Cohen's d. Results: Patients' mean age was 70.7 years (±6.6). Mean scores for the function scales ranged from 58.5 (±31.1) for role function to 86.1 (±17.0) for cognitive function. Compared to the GP, our sample reported significantly lower scores for global health status, social, role and physical functioning, and a significantly higher score for cognitive functioning. No differences were found in emotional functioning scores. Patient or Public Contribution: No patient or public contribution. [ABSTRACT FROM AUTHOR]

WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT • From 1993 to 2005, the number of academic clinical drug trials in Denmark decreased by 38% with a small increase in 2006. Commercial clinical drug trials in Denmark were subject to a similar decrease. Implementation of the European Clinical Trials Directive in 2004 had no immediate effect on the number of either academic or commercial clinical drug trials. WHAT THIS STUDY ADDS • Our study shows that randomization, definition of primary endpoint, monitoring according to the principles of Good Clinical Practice (GCP monitoring), and control of medicine compliance form part of a significantly increasing percentage of academic clinical drug trials. This indicates an increasing quality of these trials. • However, high numbers of unblinded randomized controlled trials and randomized controlled trials utilizing unacceptable methods for generation of allocation sequence emphasize the potential for further improvement of the methodological quality. 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 characteristics were collected, e.g. statement of primary endpoint, use of control group, blinding, randomization, method for generation of allocation sequence, monitoring according to the principles of Good Clinical Practice (GCP monitoring) and publication. RESULTS Statement of primary endpoint increased from 60 to 90% of trials ( P < 0.0001). Comparing the period before and after implementation of the Clinical Trials Directive in 2004, intention of GCP monitoring increased from 13% to 94%. Control of medicine compliance increased from 42% to 76% ( P < 0.0001) among trials with self-administration of the investigational medicinal product. Among controlled trials use of randomization increased from 78% to 94% ( P= 0.0063) of trials. Remaining characteristics did not change significantly. In total 68% (264/386) were randomized controlled trials. CONCLUSIONS Our study shows that randomization, definition of primary endpoint, GCP monitoring, and control of medicine compliance form part of a significantly increasing percentage of academic clinical drug trials. This indicates an increase in the quality of academic clinical drug research in Denmark 1993-2005. However, high numbers of unblinded randomized controlled trials and randomized controlled trials utilizing unacceptable methods for generation of allocation sequence emphasize the potential for further improvement of trial methodology. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]