Despite strong economic and logistical arguments to be made for conducting clinical trials in Brazil, Russia, India and China (the BRIC countries), increasingly complex regulation, corruption and patent challenges are forcing drugmakers to up their game to succeed, according to a new report from Thomson Reuters Life Sciences.
Those that are succeeding are building strong relationships with regulators, local contract research organizations, consultants and communities, according to Beth Nuskey, author of the report and a pharmaceutical research analyst at Thomson Reuters.
With a pool of almost 3 billion patients near research centers in major cities, drugmakers have been attracted to BRIC nations by the opportunity to recruit patients quickly and cost-effectively. Ample availability of trained health professionals and nearby investigational medicine manufacturers makes the idea of running a trial in a major city even more compelling.
But in spite the advantages BRICs present, only China managed to escape a downturn in clinical trial starts that affected Brazil, Russia and India between 2012 and 2013, Nuskey concluded, citing data from Cortellis Clinical Trials Intelligence.
India fared worst in declining trial starts, even though the nation boasts a large, diverse, and mostly treatment-naïve patient population. A need for affordable quality care, especially in noncommunicable diseases such as cancer, makes recruitment relatively easy and retention high. However, the Indian regulatory landscape often moves faster than foreign pharmaceutical companies can keep up with, Nuskey reported.
In 2013, for instance, new provisions in India's Drugs and Cosmetics Act relating to the ethical supervision of trials and compensation of trial subjects led the U.S. National Institutes of Health and many other trial sponsors to cancel trials and move them to friendlier environs in places like Korea and Canada.
In Russia, where expenditures on health care and R&D investment are growing with government support, efforts to localize global pharma expertise are paying off. Yet ethical issues can still stall progress, noted Nuskey, citing an instance in which Biogen Idec Inc. had to shut down all the Russian sites for a phase II trial because investigators didn't want their trial income reported to state employers.
Nonetheless, Novartis AG and Glaxosmithkline plc, Amgen Inc. and Eli Lilly and Co. still boasted a strong presence in the country, with local companies such as Biocad Ltd. catching up.
Brazil, with its large patient population and reduced access to what Nuskey called "beyond-basic level care," has many potential trial subjects that are largely treatment-naïve. It also had the fewest 2013 trial starts among the BRICs, probably due in large part to potential cost savings – 20 percent to 30 percent relative to Western markets – being less than what other BRIC nations offer.
While patient retention in Brazilian trials can be strong, a complex and often lengthy approval process for new trials keeps many would-be sponsors away. Applications for placebo trials require additional scrutiny. But more daunting, a compassionate-use program guarantees free supplies of orphan drugs to patients who participated in and benefited from a drug in its phase III trial, virtually eliminating the opportunity for drugmakers to profit from later selling drugs to the same small patient populations that tested it.
China, the only BRIC nation seeing a year-over-year increase in the number of trials initiated, stands to become the second largest pharmaceutical market in the world in 2017. With its large and aging population, strengthening regulatory picture and growing supply of health care professionals, China is proving to be an increasingly attractive venue in which to run high-quality trials at cut rates, Nuskey noted.
Underlying its development is a fast-growing infrastructure to support trials there, according to the report. Astrazeneca plc recently partnered with Beijing's top clinical research laboratory, Pharmaron Beijing Co. Ltd., and other companies are increasing their presence in the country as CROs such as Quintiles Inc., Parexel International Corp. and Covance Inc. build capacity.
As clinical testing R&D migrates to lower cost centers, Harvard Bioscience Inc., a Holliston, Mass.-based scientific instruments company, is following it. "We're seeing new labs start up, increased activity in pharma and CROs in China," Jeffrey Duchemin, CEO and president of Harvard Bioscience, told BioWorld Today. "It's vital that we align with the right distributors that have the right presence in China," he said, "with representatives in government facilities, CROs, pharma and academic institutions."
The number of trials in China are likely to grow, Nuskey said, but what happens next in other nations will depend largely on how regulators move to shape their domains. "One thing is for sure," she wrote, "the BRIC clinical trial climate is changing."