The US is still dominant in the clinical trials arena, carrying out 53 per cent of the world's 59,000 Phase I-III studies, however, US investigator groups are continuously underperforming with patient recruitment, with 50 per cent of sites recruiting less than 5 per cent of patients and 30 per cent recruiting 50 per cent of patients. Despite notorious issues with recruitment, this is no longer the country's number one cause for trial delay either, with contract and budget delays taking over the number one spot of woe and 94 per cent of all US trials are now delayed over a month. Meanwhile in Europe, ethics committee review and application; patient recruitment; legal review, contract and budget negotiations; and protocol amendment are the biggest trial headaches. As a result, R&D spend by pharmaceutical companies is growing by 10 per cent a year in the US - with much of this being spent on Phase III studies - while their spend outside the US is growing 13 per cent. At the same time, the number of foreign trials included as part of new drug application (NDA) submissions rose from less than 100 in the 1980s, to over 4,500 in 2004, although despite this jump, it is still only 10 per cent of the total. Despite all the outsourcing hype of late, countries in emerging markets such as India, Asia-Pacific, Eastern Europe and Latin America actually only see 6 per cent of trials coming their way, although this figure is growing as more and more sponsors are lured by the promises they offer. "Latin America is particularly strong in this field at the moment but receives little attention," said Dan McDonald, vice president of Strategic and product development for consultancy firm D. Anderson & Company, in a presentation. "As a result there are several new contract research organisations (CROs) popping up in the region and many of the large established CROs are opening offices here." The biggest challenge in operating in the region is regulatory delays, which are greater than other emerging market regions. As a result, 41 per cent of all trials here are delayed by over one month, although this is still significantly less than in US and Europe, McDonald pointed out. According to McDonald, Argentina is the most advanced in terms of regulatory processes and has more than doubled its clinical trials business since 1994 - it now runs 32 per cent of the region's clinical trials. Brazil is not lagging far behind Argentina in terms of progress and is the recipient of 29 per cent of Latin America's trials. Meanwhile, the Asia-Pacific was described as a "clinical sleeping giant on the verge of awakening". China has 52 per cent of the Asian clinical trials market share, and its clinical research market is growing by over 20 per cent each year. Although its nearest competitor India dwarfs in comparison with only a 20 per cent market share, the potential in the country is still huge and spend on CRO services there is tipped to surpass 300m by 2010. Despite the potential, regulatory hurdles are still substantial, experience and infrastructure can be poor and sponsors operating "really need to be there on the ground" to make sure everything is running to plan, said McDonald. In light of these considerations, Thailand, Singapore and Malaysia are currently the most favourable countries to run trials, he said. Meanwhile, Central Europe is a "hidden clinical trial gem," said McDonald. The eight-country area offers 20 per cent savings on study costs, 400m treatment naïve patients, most of whom are part of a centralised health system. "There have been over 1,500 new study registrations here in the past year, he said. Adding Russia and the Ukraine to the mix makes the region even more lucrative, with 200m treatment naïve patients - greater than in all 12 Western European countries combined - and a recruitment rate between two and ten times faster as well as a cash saving of up to 50 per cent compared to the west. As a result trials from the US have tripled here in the past three years and both the European Agency for the Evaluation of Medicinal Products (EMEA) and the US Food and Drug Administration (FDA) are now approving drugs with trial data from Russian sites. South Africa was also identified as "up and coming," due to its large multicultural population with a mixture of Asians, blacks and Caucasians, and its position of "gateway to Africa," providing access to both third and first-world diseases. The country is also said to hold "a strong rescue capability," offering significantly faster recruitment than the US and Europe. Meanwhile, US sponsors may not always have to look so far when looking for potential testing grounds, as McDonald highlighted rural US as a potential domestic hotspot. "Rural US hasn't been tapped to its full potential," said McDonald. "There are up to 500,000 treatment naive people in this area, 75 per cent who are traceable through specialty clinics or group practices."
An increasing number of factors are luring sponsors to offshore clinical trials to 'hidden gems' across the globe, delegates heard at this week's Accelerating Patient Recruitment & Retention in Clinical Trials conference, run by SMi in London.