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

Berendt, Louise; Håkansson, Cecilia; Bach, Karin Friis; Dalhoff, Kim; Andreasen, Per Buch; Petersen, Lene Grejs; Andersen, Elin; Poulsen, Henrik E.

doi:10.1136/bmj.39401.470648.be

Cited by 23 publications

(26 citation statements)

References 3 publications

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“…Similarly, outside Finland there has been a special focus on drug trials due to the drug industry’s commercial interests and lobbying power, and in a European context, also due to the EU mandate. It has been said that the European Clinical Trials Directive (in force since 2004) makes drug trials more difficult to undertake and has specifically decreased the number of trials sponsored by non-commercial actors [16,24-26]. Hope for reducing these problems has now been put in modification of the Clinical Trials Directive, which is currently (Spring 2013) under discussion (Piret et al, unpublished manuscript).…”

Section: Discussionmentioning

confidence: 99%

Clinical research in Finland in 2002 and 2007: quantity and type

Hemminki

Virtanen

Veerus

et al. 2013

Health Res Policy Sys

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BackgroundRegardless of worries over clinical research and various initiatives to overcome problems, few quantitative data on the numbers and type of clinical research exist. This article aims to describe the volume and type of clinical research in 2002 and 2007 in Finland.MethodsThe research law in Finland requires all medical research to be submitted to regional ethics committees (RECs). Data from all new projects in 2002 and 2007 were collected from REC files and the characteristics of clinical projects (76% of all submissions) were analyzed.ResultsThe number of clinical projects was large, but declining: 794 in 2002 and 762 in 2007. Drug research (mainly trials) represented 29% and 34% of the clinical projects; their total number had not declined, but those without a commercial sponsor had. The number of different principal investigators was large (630 and 581). Most projects were observational, while an experimental design was used in 43% of projects. Multi-center studies were common. In half of the projects, the main funder was health care or was done as unpaid work; 31% had industry funding as the main source. There was a clear difference in the type of research by sponsorship. Industry-funded research was largely drug research, international multi-center studies, with randomized controlled or other experimental design. The findings for the two years were similar, but a university hospital as the main research site became less common between 2002 and 2007.ConclusionsClinical research projects were common, but numbers are declining; research was largely funded by health care, with many physicians involved. Drug trials were a minority, even though most research promotion efforts and regulation concerns them.

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Section: Discussionmentioning

confidence: 99%

Clinical research in Finland in 2002 and 2007: quantity and type

Hemminki

Virtanen

Veerus

et al. 2013

Health Res Policy Sys

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“…Over the last few years, there has been a decline in the number of clinical trials in several European countries [33,34]. In Norway, the largest reduction has been in phase III studies [16].…”

Section: Discussionmentioning

confidence: 99%

Clinical drug trials in general practice: a 10-year overview of protocols

Brænd

Jensen

Klovning

et al. 2013

Trials

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BackgroundDrugs predominantly prescribed in general practice should ideally be tested in that setting; however, little is known about drug trials in general practice. Our aim was to describe drug trials in Norwegian general practice over the period of a decade.MethodsThe present work concerns a 10-year retrospective study of protocols submitted to the Norwegian national medicines agency (1998 to 2007) identifying all studies involving general practitioners (GPs) as clinical investigator(s). We analyzed the number of trials, drug company involvement, patients, participating doctors, payment, medications tested and main diagnostic criteria for inclusion. We also analyzed one trial in greater detail.ResultsOut of 2,054 clinical drug trials, 196 (9.5%) were undertaken in general practice; 93% were multinational, 96% were industry funded and 77% included patients both from general practice and specialist care. The trials were planned to be completed in the period 1998 to 2012. A total of 23,000 patients in Norway and 340,000 patients internationally were planned to be included in the 196 trials. A median of 5 GPs participated in each trial (range 1 to 402). Only 0.7% of 831 GP investigators had general practice university affiliations. Median payment for participating investigators was €1,900 (range €0 to 13,500) per patient completing the trial. A total of 30 pharmaceutical companies were involved. The drugs most commonly studied were antidiabetics (21%), obstructive airway disease medications (12%), agents acting on the renin-angiotensin system (10%), and lipid modifying agents (10%). One trial, presented in more detail, had several characteristics of a seeding or marketing trial.ConclusionsOnly one in four drug trials involving general practice were solely general practice trials and almost all were industry initiated without input from academic general practice. There was a large variation in the number of patients, participating doctors, and economic compensation for trial investigators, with some investigators receiving substantial payments.

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“…In addition there was a sharp decrease in the percentage of academic trials in 2004, though this increased in the following years 34. In contrast, figures from the National Monitoring Centre on Clinical Trials and Drugs in Italy35 shows a steady increase in the number of clinical trials during implementation of the Directive, and similarly no significant decline in academic or commercial trials was found in a study of applications to the Danish Medicines Agency following implementation of the Directive 36…”

Section: Effect Of the Directive On Clinical Trial Activity In Europementioning

confidence: 91%

‘(More) trials and tribulations’: the effect of the EU directive on clinical trials in intensive care and emergency medicine, five years after its implementation

Robinson

Andrews

2010

J Med Ethics

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The European Clinical Trials Directive was issued in 2001 and aimed to simplify and harmonise the regulatory framework of clinical trials throughout Europe, thus stimulating European research. However, significant complexity and inconsistency remains due to disparate interpretation by EU member states. Critical care research has been particularly impacted due to variable and often restrictive consenting procedures for incapacitated subjects, with some countries requiring a court-appointed representative, while others recognise consent from family members and occasionally professional representatives. Furthermore, the absence of a waiver of consent threatened to put an end to emergency research in Europe and was met with varied responses. Approval procedures by ethics committees are equally inconsistent, particularly those relating to provision of a single opinion for multi-centre trials. Although evidence is somewhat mixed, this complexity as well as a general increase in administrative and financial burden following the Directive has been shown to cause a reduction in clinical trial activity in Europe, particularly academic trials. We aim to clarify some of these inconsistent procedures, particularly those relating to informed consent of incapacitated subjects, as well as discussing some general weaknesses and possible improvements of the Directive ahead of its planned revision in 2011.

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

Abstract: ABSTRACT

Cited by 23 publications

References 3 publications

Clinical research in Finland in 2002 and 2007: quantity and type

Clinical research in Finland in 2002 and 2007: quantity and type

Clinical drug trials in general practice: a 10-year overview of protocols

‘(More) trials and tribulations’: the effect of the EU directive on clinical trials in intensive care and emergency medicine, five years after its implementation

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