A new online and searchable European register of clinical trials in children

A new online and searchable European register of clinical trials in children, which has been developed in collaboration with academics at The University of Nottingham and will make the practice of paediatric medicine safer and more effective, has recently been launched.

The register is a landmark in the field of clinical research because it will be the first clinical trials database dedicated to the paediatric population. Developed by four European child health centres — Derby, Milan, Paris and Barcelona — it will address the well-documented lack of scientific knowledge on the use of medicines in children.

The British arm of the register has been developed by the University’s Academic Division of Child Health, based at Derbyshire Children’s Hospital. It is being developed and managed by Professor Imti Choonara, Dr Helen Sammons and Dr Joel Steingo.

Dr Steingo said: "Several factors have been blamed for the lack of research being performed in sick children — including a lack of financial incentive and practical difficulties in performing trials — but the common outcome is that health professionals treating children are often forced into using medicines that are only licensed for use in adults. This means that the drugs used to treat children are often not used to their full potential and may even be potentially toxic to them."

For several years now, Dr Steingo added, clinicians have spoken about the creation of clinical trial ‘registers’ to keep track of ongoing and planned trials. The intention of a register is to promote transparency within the realm of clinical research and to provide access to current information for anyone interested, including health professionals and the public.

From a professional’s perspective, a register helps to prevent duplication and under-reporting of trials and publication bias. It also helps to promote coordination of research, identification of patients’ therapeutic needs, collation of knowledge, and guidance in allocation of funds. From a patient’s point of view, it can help to identify trials relevant to that patient’s condition, allowing them to enrol onto trials that study the most up-to-date medicines.

Several medical research registers have been developed over the past decade. However, they have all failed to address the paediatric population adequately and have not succeeded in stimulating the much-needed research on medicines for children.

The new register is international, web-based, will allow free access to all and contain a set of core information for each trial entry, including such fields as title of trial, research question and contact details for the lead researcher. It will be updated every six months and be searchable to professionals and the public. Parents will therefore be able to identify trials in their region in which their children might be eligible for participation.

The project has been backed by the Royal College of Paediatrics and Child Health, the body responsible for training paediatricians and setting standards of child health practice in the UK, and the Neonatal and Paediatric Pharmacists Group, a network of British paediatric pharmacists.

The new database can be accessed on the web at www.dec-net.org

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