Abstract
IntroductionPaediatric non-commercial interventional clinical trials (NICTs) are crucial for healthcare provision. In spite of the fact that current regulations and initiatives try to enhance the quantity and quality of paediatric NICTs, there are still shortcomings that need to be addressed in order to accelerate the conduct of relevant clinical trials in children. To improve the current landscape of paediatric clinical research, it is necessary to identify and analyse the main trends and shortcomings, along with their impact on national performance in paediatric NICTs and this is the aim of this work.MethodA retrospective systematic search of paediatric NICTs was performed on four international clinical trials registries. Entries were filtered by date from 01/01/2004 to 31/12/2017. Each identified paediatric NICT was screened and analysed for sponsors, funders, type of intervention, therapeutic area, design characteristics and associated publications.ResultsThe search identified 439 unique NICTs. When stratifying the trials by enrolment ages, 86 trials were found involving the paediatric population. Most trials investigated the use of medicinal products and were focused on cancer or cardiovascular diseases. The most common sources of the funding were non-profit organizations. Furthermore, from the total number of completed trials, only half of them already published their results.ConclusionThe main shortcomings—specifically, ethical, methodological and, in particular, economic obstacles were identified. There is a continual need for greater support and collaboration between all major stakeholders including health policymakers, grant agencies, research institutions, pharmaceutical industries and healthcare providers at the national and international level.
Highlights
Paediatric non-commercial interventional clinical trials (NICTs) are crucial for healthcare provision
We identified all paediatric NICTs which were registered between the dates 01/01/2004 to 31/12/2017 from recruitment sites in the Czech Republic
Non-commercial clinical trials are the basis of a country’s clinical research strength [45, 46]. They have a crucial importance for healthcare provision, as they answer questions which are highly relevant but often disregarded by the pharmaceutical industry, especially in the case of the paediatric population due to its very low profitability [47]
Summary
Paediatric non-commercial interventional clinical trials (NICTs) are crucial for healthcare provision. In comparison with adult medicine, it is striking because adult patients are treated exclusively with drugs developed, authorized and confirmed in clinical trials designed for the adult population. A child is not just a small adult and in the absence of specific trial-based data on children, clinicians are forced to extrapolate from results of trials on adults [4]. This extrapolation is often inappropriate because children have a different range of diseases and the drugs hold different pharmacokinetic and pharmacodynamic characteristics in children, resulting in responses to treatment that are unpredictably different to adults and can be endangering [5]. Paediatric clinical trials have been largely neglected over the long term which has led to a lack of available data of efficacy and safety even of drugs which we have been administering for decades [7]
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