Today, half of all clinical trials are conducted offshore and in more developing countries than ever before, profoundly increasing the complexity of supply chain logistics. Emerging markets in Asia, Latin and Central America, the Middle East, Africa and Eastern Europe—many of which didn’t make the short list for trials in the past—are becoming sought-after study locations. Their newfound popularity comes at a time when drug development costs are higher than ever and competition is emerging from some of the very markets to which trials migrated nearly two decades ago, primarily China, India and even Korea. ClinicalTrials.gov documents the ongoing shift. In 2012, the website listed more than 136,000 clinical trials taking place in 181 countries, a number that has been climbing steadily. About 40% of clinical trials took place in emerging nations of Asia, Latin America, and Africa.
While an enlarged clinical trial universe certainly benefits patient recruitment and diversity, it also multiplies the operational and strategic obstacles that clinical trial professionals must circumvent: In addition to inexperience in conducting trials, there are wide-spread differences in quality standards, customs knowledge, laws, and regulations for clinical trials and the protection of research subjects. Other challenges include managing logistics in countries with limited infrastructure. The growth of studies testing temperature-sensitive biologics with special handling and transportation presents additional logistical challenges across the supply chain.
Finally, there are regional idiosyncrasies—language differences, both spoken and unspoken, culture and religion—that add another layer of complexity. While challenging, none of these are insurmountable. Navigating them successfully, however, requires a well-defined, sustainable process capable of mitigating risk from the beginning to the end of the supply chain. Thermo Fisher Scientific has an industry-leading supply chain management solution, which is exclusively focused on serving the packaging and distribution requirements of clinical trials across the world. In addition to having the largest global footprint in the clinical supply chain industry, Thermo Fisher continuously invests in facilities, technology, people, and training across the world. This paper discusses the challenges of conducting clinical trials in emerging markets and how to navigate them.