The Institute of Clinical Research (ICR) has recently taken two initiatives reflecting key trends in the clinical development sector. One is to form a special interest group focusing on clinical trials for children, the other to appoint the ICR’s first country manager for India.

The Paediatric Special Interest Group (PSIG) will provide advice and commentary on the European Union’s new regulation on paediatric medicines, which came into effect on 26 January. It is chaired by Dr Philippa Smit-Marshall, executive medical director for Europe and Asia Pacific at contract research organisation (CRO) Pharmanet.

Nothing that clinical research in children presents a number of ethical and technical challenges, Smit-Marshall said: “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.”

The appointment of Shamiq Hussain as ICR country manager for India followed a successful fact-finding trip to India last November by Dr John Hooper and Alan Needham, respectively the Institute’s chief executive and corporate development manager. Hussain, who operates out of an office in Jakkur, Bangalore, has a background in both the pharmaceutical and clinical research industries, with stints at SmithKline Beecham, ClinTec International and a number of CROs.

He will work in partnership with local professional bodies and organisations to establish ICR as the leading organisation for clinical research professionals in India. At the moment, Hussain is focusing on awareness-raising and building an ICR membership in India. That includes university students as well as clinical research professionals and the pharmaceutical industry. Once these goals are achieved, he will start looking at opportunities for training and standard-raising.

Hussain described the clinical research environment in India as “nascent but growing”. The sector only really started to take off in 2001, but over the last two to three years some 20 to 25 CROs have set up shop in the country, he noted. Analysts have forecast that the industry could be worth US$1 billion by 2010, although Hussain regards that figure as optimistic given India’s current shortage of trained personnel for clinical trials, including investigators qualified in Good Clinical Practice.

The ICR held its 28th Annual Conference and Exhibition this week in Birmingham, UK.