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The favoured method of shipping pharmaceuticals is by sea, mostly due to its cost-saving benefits. But sometimes, the industry must get products to a location fast; clinical trials are a case in point. In this instance, air freight is necessary, but does this method present its own unique challenges as far as effectively managing the temperature of products is concerned? Richard Peck, director of RP Pharma Consulting and former global head of the process-controlled transportation centre of excellence at AstraZeneca, tells Peter Littlejohns when products qualify for travel by air freight and discusses some of the innovations that allow companies to control temperatures to reduce the risk of excursions on the journey.
33 Reimagine the
pharma supply chain Controlant
Trial design 34 Adapt to learn
Using data to modify the operating characteristics of an active trial in accordance with pre-specified rules, adaptive designs can make clinical trials more flexible, efficient and informative than fixed-sample designs. In oncology, where there’s often high variability between the way patients respond to treatment, this style of design can minimise patient exposure, as well as enable an early decision to terminate if the
Clinical Trials Insight /
www.worldpharmaceuticals.net
treatment appears to not be working. Mae Losasso speaks to Tianjian Zhou, assistant professor in the department of statistics at Colorado State University, and James Wason, professor of biostatistics at Newcastle University, to discuss the ins and outs of adaptive design.
Outsourcing 37 A rising star
While Europe and the US are still popular clinical trial destinations, recent years have seen a move towards more developing countries. From enthusiastic subjects to lower costs, that’s not hard to understand, with Asia-Pacific a rising star in the trial space. But what about the countries in this region make them a prime choice for conducting a drug trial – and can conveners
overcome the political and cultural barriers they sometimes face here? Andrea Valentino speaks to Sheraz Ali at the University of Tasmania, and Professor Victoria Elegant at Amgen Asia Pacific, to learn more.
41 Vendor management – more than relationship management? Lumis Life Science
43 Streamlining clinical trials across the board ProofPilot
46 Measurable success Cerba Research
Data management
48 Augment and accelerate Technology is transforming the way clinical trials are run – the days of recording trial information on paper and storing it in large filing cabinets are at an end. So how important is it that a sponsor chooses a clinical research organisation that makes full use of a range of eClinical tools in running a trial? Kim Thomas talks to Max Horneck, head of clinical data management and eClinical systems at Medac, and Michael Rosenblatt, clinical operations portfolio leader at Roche, about how digital capabilities are becoming an increasingly important part of choosing a CRO.
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