It's all about trust

Alemany Amparo at TFS named in published article: "The Paediatric Working Group of EUCROF"

Piergiorgio Galletti, Medical Director, Pierrel Research (Italy) and Dr. Martine Dehlinger-Kremer, Leader, EUCROF Paediatric Working Group and Vice President, Global Regulatory Affairs, RPS Research (Germany)

The European CRO Federation, EUCROF, was founded in October 2005 by national CRO associations of France, the Netherlands, Germany, UK, Italy, the Czech Republic and Spain with the clear aim to promote high quality research in Europe.

EUCROF represents the interests of CROs based in Europe and maintains close relationships with regulatory bodies, pharmaceutical and biotech industry, and medical research communities. Currently, EUCROF has nine full members, i.e. CRO associations from Belgium, France, UK, Italy, the Netherlands, Germany, the Czech Republic, Spain and Turkey, and four associate members (individual CROs) from Portugal, Poland, Greece and Ireland. Over 260 small-to-medium and large CROs belong to EUCROF, totalling more than 11,000 professionals.

Various activities are promoted by EUCROF through specific working groups, one of them being the Paediatric Working Group (PWG), founded in 2007. Currently, the PWG consists of eleven members, based in the Czech Republic, France, Germany, Italy, Spain and the Netherlands. The PWG is currently focusing on clinical research methodology and ethics in paediatric clinical trials, with the aim of improving awareness of the need for clinical studies in children.

Clinical studies in children of different ages require special attention, knowledge and sensitivity as regards the peculiar characteristics of the paediatric population in terms of biology, pharmacology, therapy and need for appropriate psychological approach. This is also reflected in Chapter 4, ‘Clinical trials on minors’, of the EU Clinical Trials Directive 2001/20/EC to safeguard the rights and wellbeing of children participating in clinical research.

Children (a term used in the present article in a broad sense, encompassing all paediatric sub-populations from birth to the legal age of adulthood) are subject to many of the same diseases as adults and, consequently, are often treated with the same drugs. However, a large proportion of medicines administered to children are unlicensed for the specific age group and are prescribed off-label, which can place children at risk of under- or overdosing and of acute or long-term adverse effects. Data needed for effective and safe treatment of children cannot be linearly abstracted from adult data, thus specific research in children is necessary. In addition, there are diseases specific to children.

The difficulties in carrying out studies in children, due to ethical and practical constraints, and the costs of such research in children for pharmaceutical companies, in a relatively restricted market, are some of the reasons for the low percentage (about 30 per cent) of drugs which are specifically licensed in Europe for use in children. In order to improve the regulatory environment and give impulse to paediatric research, the European Parliament and the Council published the Paediatric Regulation (EC Regulation No. 1901/2006 as amended), which entered into force on 27th January 2007. As per the Paediatric Regulation, any new drug to be marketed in the EU, as well as any addition of indication, or new pharmaceutical for approved drugs in the EU, must have a Paediatric Investigation Plan (PIP) agreed with the European Medicines Agency. Incentives are provided to companies developing medicinal products for the paediatric population, such as free scientific advice for the PIP and a six-month extension of the patent protection. For products out of patent, an optional new marketing authorisation, Paediatric Use Marketing Authorisation (PUMA), is available when a paediatric indication is developed. The incentive for the latter is a ten-year data protection.

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