This article was first published in the Journal for Clinical Studies, Apr 2014
Clinical research used to be always carried out in the well-funded locations of North America and Western Europe, with a smaller number in Australasia. This is no longer the case because of several factors. Saturation is approaching in available sites in the West, which has led to a lack of naive patients available and willing to take part in trials. This has led companies to seek new locations to run trials, which is much easier than it used to be because of the huge improvements being made in emerging markets in investigator and patient identification and regulatory initiatives.
Countries like India and Brazil have invested in significant infrastructure programmes to improve the way that they handle clinical trials applications, including trial review, and the granting of import licences and permits. IMP supplies can be imported relatively quickly to allow trials to take place at the same time as those in Western Europe and North America. It is possible to make huge cost reductions by performing trials in Eastern Europe, Latin American and Asia. In Russia, China and other countries, it is possible to reduce operational costs and have trials conducted in large hospitals which have patient catchment areas numbering millions to speed patient recruitment.
Additionally, more countries have a requirement that clinical trials must be conducted in that country prior to marketing new drugs. Only once local testing has been done can an application for inclusion in the market be considered. China, for example, spent approximately 66.8 billion US Dollars in 20111 and that level of spend cannot be ignored by any company in the global marketplace.
There are a lot of new countries where trials are taking place; for example, in South America there are a total of 5432 trials, and in South East Asia there are 32502. The really interesting element is how many countries have started running trials. Brunei Darussalam, for example, has one carcinoma study running at the moment, and there are many other countries with small numbers of trials, which can only increase over time. The Middle East and Africa are showing significant growth in clinical trials numbers as the market looks for even more new destinations. Each of these countries represents challenges in logistics, ensuring temperature control, arranging customs clearance and regulatory release. There are many hazards in arranging shipping, requiring knowledge of local requirements, from how to address the package to what storage is available in individual airports.
If sending to Vietnam (and several other countries), you cannot address the package to an individual as it would be considered a personal package, even if a pallet load, and the recipient is likely to become personally liable for any duty or taxes applied to the shipment. This can lead to problems making deliveries into a big hospital, particularly for time-/temperature-sensitive items, and clinical trial supplies being received into a pharmacy department being stored incorrectly, because personnel with knowledge about the specific storage requirements may not have been advised.
Clearance can take many days, depending on the infrastructure, number of clinical trial shipments arriving at any one time, type of supply and individual country regulations. During this time it may be possible to access the consignment to refresh refrigerant, but a lot of the time reliance is on the warehouse storage facility at the airport. In Cambodia, at Phnom Penh International Airport, there is no freezer, one refrigerator set at +2 to +8C: (4 x 3 x 2m, door size 1.8 x 1m) which is not qualified or controlled, and a ‘controlled ambient’ area set at +20 to +25C, which is also not qualified or controlled. Knowing this kind of information makes it possible to plan, choose the airport of entry, the packaging, and even the time of year to ship. Laos has three seasons in the year: hot, cold, and rainy (although the temperature is rarely below 15°C even in the cooler months). August and September see a significant rise in rainfall with frequent tropical downpours. Given the limited airport facilities and time that shipments can be left on the runway, it is probably prudent to send a couple of weeks early or later, if this can be factored into your plans.
The secret to successful shipping into emerging markets is forward planning and research, local contacts and knowledge, and a degree of flexibility and pragmatism.
1. International Federation of Pharmaceutical Manufacturers & Associations. The Pharmaceutical Industry and Global Health Report—Facts and Figures 2012