Pharma Business Report Series -BRIC Clinical Trial Report Part 5
This is part 5 in Pharma IQ’s report series from a survey of 573 members from the clinical trials community. For the rest of the instalments of this series, please visit our pharma business resource centre.
Although they saw great promise in the BRIC regions, 46% of survey respondents only ran 0 – 20 % of their clinical trials in Brazil, Russia, India and China. Just over a quarter ran 21 – 40 % in the BRIC countries and just 3.6% ran over 81 % of their clinical trials in a BRIC country.
As the emerging markets become more favourable destinations for conducting clinical trials, the challenges faced by clinical trial management become more complex, with challenges such as cultural barriers, understanding local regulations, importation and exportation guidelines and obtaining of licenses.
Mark Walls, Director of Clinical Pharmacy at Human Genome, said to Pharma IQ: “In addition to all the positives of carrying trials out in emerging markets, some hurdles that companies would face include cultural differences, one of the big differences is time differences, there could be some language barriers, you could potentially have some lack experience, import export challenges, training in your area, exporting the product.” Dealing with electronic data capture, you could also have issues with phone and internet access,” he added.
Global standardisation vs. local regulation Pharma IQ asked the survey participants to pinpoint the main challenge for running clinical trials in BRIC countries.
Adherence to global standards was cited as the number one response with nearly a third of participants, 32.2%. Pharmaceutical companies must assume responsibility for their product quality and safety and therefore need to ensure that the companies they work with globally comply with not only local but also globally recognised standards.
To continue reading about the findings from our survey please visit the Pharma IQ’s dedicated pharma business resource centre. Alternatively you may find our webinars, whitepapers and articles useful as they cover a broad spectrum of the industry and are produced in partnership with some of the biggest companies across the pharma sphere.