The Institute of Clinical Research (ICR) has formed a special interest group focusing on clinical trials in children, following new EU commission regulations
The Paediatric special interest group (PSIG) will provide advice and commentary on the guidelines set out by the new EU commission regulations and will aim to raise the profile of paediatric trials and work to enhance services in this area.
Chairman of PSIG is Philippa Smit-Marshall, executive medical director for Europe and Asia Pacific at Pharmanet.
She commented: "The Paediatric Regulation provides an ambitious framework to stimulate clinical research in children, providing funding to clinical research networks for academic research and incentives to the industry to define the safety and efficacy of medicines for paediatric use where there is a clinical need.
"There will be many ethical and technical challenges to all those involved in clinical research in children.
"The coming months will show if the regulators, industry and clinical researchers can rise to those challenges and if the framework provided by the regulation is an adequate incentive to conduct research in children.
"The Paediatric SIG hopes to be able to support clinical research professionals from all sectors in their work through providing information, education and a platform for debate".
Prior to the new regulations being announced, there were no separate rules for adult and child clinical trials and therefore smaller doses were given to children.
The new regulations will make the system more robust and will also take informed consent issues into consideration.
Not only has the ICR established the PSIG but its annual spring conference and exhibition will also feature sessions covering paediatric and ethics issues.
Richard Tiner, the medical director of the ABPI and a member of PSIG, will be speaking about Building on Improvement: establishing a national research ethics service while Christopher Schlebusch of Chiltern International is speaking about Paediatrics: Children in Clinical Research.
The 28th ICR Annual Conference and Exhibition is the largest event of its kind in Europe.
The event, titled Clinical research - Raising the profile and challenging the boundaries, is expected to attract more than 1200 attendees from across the pharmaceutical industry, academia and the health services.
