Survey Reveals Trend Towards Expansion in Clinical Trial Supply in 2011
Despite all the talk of cost cutting and increasing efficiency, the number one priority for key stakeholders in the clinical trial supply arena is supporting the expansion of new trials, into new therapeutic areas and emerging markets.
Expansion is top priority
In a recent survey conducted on behalf of Pharma IQ’s Clinical Trial Supply Europe, a massive 63 percent of respondents said that there number one priority for 2011 was supporting numerous new areas, and 18 percent, working specifically for trials in emerging markets was the top priority for 2011.
It would appear from the findings of the survey that the clinical trial supply market is set for growth in 2011, with 43 percent of participants looking to invest in cool chain technologies and 33 percent in emerging markets.
In an interview with Pharma IQ, Almut Malone of Global Logistics Clinical Supplies at Bayer Schering Pharma AG, spoke about balancing costs and which areas she thinks require the most investment to improve overall temperature-controlled shipping in clinical trial supply. She said: “The best investment is always in the area of minimising human error and achieving awareness across all parties in the requirements of handling such goods.”
Pharmaceutical companies and logistics providers must implement best practices in temperature sensitive storage and distribution to ensure successful on-time delivery of clinical supplies and products every time. “In clinical trials, the number of "failed shipments" must be reduced to the possible minimum, because there is not always sufficient stock to replace unusable supplies,” said Malone.
Emerging challenges for clinical supply
As the emerging markets become more favourable destinations for conducting clinical trials, the challenges faced by the supply chain become more complex, with challenges such as cultural barriers, understanding local regulations, importation and exportation guidelines and obtaining of licenses.
From their experience of the emerging markets 52 percent of the survey participants found Russia and the Ukraine the most difficult areas to ship to, followed by China at 29 percent, Latin America 14 percent and India 5 percent.
Alex Klim, product manager for DHL Supply Chain’s Clinical Trials Logistics Service (CTL), said to Pharmaceutical Manufacturing and Packing Sourcer: “In the BRIC territories the cost of not having drugs available for a patient once recruited is often countered by oversupplying; it is not unusual to have an overage of supply of about 280 per cent as a lot of the drug is put into each country to ensure there is no chance of not having the right drug when the patient turns up. As a result, tax and duty costs will be high but, more significantly, since they often have short shelf lives due to limited stability data, write-offs will not just include the production value of the drug and logistics cost, but also wasted tax and duty charges.”
Enhancing supply management is as much about removing key inefficiencies in your clinical trial supply chain, as it is about employing new technologies. For 5 percent of Pharma IQ’s Clinical Trial Supply Europe survey’s participants overage cuts are the top priority for next year.
Clinical trial supply management can make or break a clinical trial. It is crucial to the success of a trial that rregulatory requirements are fully understood and processes are in place to ensure seamless supply and distribution of clinical materials, so that clinical trial timelines are not comprised.
“Not only will supply issues cause delays that can affect the ability to hit project milestones, they will also consume management time that could be better spent elsewhere in the development process,” said Klim.