Monday, October 17, 2011
As drug sponsors increasingly look to emerging markets for greater patient access and lower trial costs, they must also consider the potential disadvantages of moving operations to a developing country when choosing the best location for a clinical trial, according to new research from Cutting Edge Information.
Sponsors and CROs have gone international. Are sites next?
Synexus’ clinical trials activity in Hungary increased by 25% during the first half of 2010. The company’s Dedicated Research Centre has been operating in Hungary since 2006 and has become one of the company’s most successful CEE sites. The Budapest-based operation has been involved in more than 74 trials since being acquired by Synexus, and has randomized over 600 patients. Dr Erika Nemeth, Synexus’ country manager in Hungary, said the trend of more clinical trials being conducted in Hungary is set to continue: “The high standards of medical and research & development expertise in Hungary has resulted in high levels of participation in clinical trials and means that pharma and biotech companies remain keen to include Hungary as part of their global clinical trial programs.” The prevalence of chronic conditions including CVD and COPD among the Hungarian population, together with little preventative healthcare and healthcare education, means the treatment naïve population remains substantial and therefore attractive for clinical trials. Also, the pharmaceutical market in Hungary is set to increase significantly in the coming decade, encouraging the major players to establish a stronger and more proactive presence there before their new drugs come to market. Synexus CEO Michael Fort said the productivity of investigators, the attractive overhead costs and the world-renowned medical expertise and innovation in Hungary make it one of his company’s key areas for future development.
Wilmington, N.C.-based PPD opened a pharmacovigilance and medical communications center in Sofia, Bulgaria, in response to growing client demand for drug safety, medical information and medical writing services in the region. This new facility is PPD’s largest safety center and its third European hub for medical communications contact center services. The company also has centers in Athlone, Ireland, and Stockholm, Sweden.
India has come a long way as a center for clinical drug trials, but is the country ready for Phase I studies? I think the short answer – and others would agree – is “no”. Take, for instance, recent comments by Ashwini Kumar, the Drug Controller General of India (DCGI), who spoke recently at the Drug Information Association’s (DIA) Annual Meeting in Philadelphia. Kumar, head of the Central Drug Standard Control Organization (CDSCO), India’s regulatory agency, said that India needed to create an environment for the best quality assurance before embarking on phase I studies…