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International Clinical Trials

Cold Chain on the Global Stage

 

Conducting clinical trials accounts for nearly one third of drug development costs, according to a recent report from Frost & Sullivan (1). In fact, the cost per patient of running Phase III clinical studies of new pharmaceuticals now tends to exceed $26,000 (2). One of the major causes of rising R&D costs is that 80 per cent of clinical trials fail to recruit patients on time (3). The migration of clinical trials into emerging markets offers a possible resolution to this issue; however, as with many aspects of drug development, this approach does not come without obstacles. This article will outline logistical issues involved in conducting clinical trials in emerging markets, and highlight measures that pharma and biotech companies can implement to ensure compliant transportation of temperature-sensitive clinical trial samples and supplies on time.

ADVANTAGES OF EMERGING MARKETS

Throughout traditional patient recruiting grounds, such as North America and western Europe, sponsors have historically competed for a limited pool of investigators and patients. Emerging clinical trial regions such as South America, eastern Europe and Asia offer access to large patient populations, the majority of which are treatment-naive. In countries within eastern Europe, sponsors have reported that recruitment rates are five to 10 times higher than in western Europe and the US (4). Furthermore, countries such as Brazil, Mexico and Argentina provide substantial advantages to sponsors conducting clinical trials there. As North and South America share the same Western hemisphere, they also share many of the same prevalent diseases. However, seasonal diseases occur six months out of phase between North America and Europe, giving researchers the ability to conduct year-round seasonal trials, which can significantly reduce development times for seasonal medications (5).

Although these regions provide access to large, treatmentnaive populations, emerging markets present regulatory and logistical challenges for companies conducting clinical trials there. Accordingly, it is paramount that pharmaceutical companies fully understand the complexities of shipping clinical trial samples and supplies to emerging countries. This will ensure any potential benefits are not compromised due to inadequate knowledge and preparation.


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As Global Head of Logistics and Facilities, Jeff Clark oversees BioStorage Technologies’ day-to-day cold chain logistics for the US and Europe. He is responsible for ensuring the integrity of clients’ biological materials throughout all phases of shipping, handling, tracking and storage. In this role, Jeff develops and manages all logistics and customer service processes, defines requirements for the company’s proprietary sample management system, and negotiates global transportation and logistics partnerships. Jeff holds a diploma from the International Air Transport Association (IATA) and International Federation of Freight Forwarders Association (FIATA). He also earned certifications in international rates and tariffs, advanced cargo agent 803-53/01 and IATA hazmat training, and is a member of the American Chemical Council.
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