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International Clinical Trials

The Forgotten Challenge

Clinical trial professionals are experienced in the challenges of transporting investigational drugs around the globe, while ensuring supply in an environment of strict temperature controls, customs restrictions and urgency to meet patient visit schedules. However, few in the industry give wider consideration to a related issue: the transportation of clinical ancillaries

Whether it be medical devices, diagnostic equipment or support materials such as computers and patient diaries, it is crucial that key ancillaries – just like drugs – are consistent in a global clinical trial taking place anywhere in the world. To a degree, this is self-evident: the medical and diagnostic equipment in lab kits must be consistent globally so as to not affect the outcome of a trial in any way. Researchers appreciate that lab kits are complex, with many trials requiring a different kit for each patient visit, or even kit components having individual serial codes or needing to be packed in the sequence in which they are needed. However, those beyond the procurement process often fail to appreciate that everything in the trial must be identical, from the computers used for electronic data capture to the patients’ diets, to instruction manuals or DVDs. The most unusual item I’ve seen transported for a pharmaceutical trial is a staircase – because the customer wanted to test if a drug caused motion pains and dizziness, and the testing mechanism had to be consistent across the world.

Supply Chain Practicalities

At first glance, it might seem that transporting clinical ancillaries is a minor, albeit crucial, add-on to wider clinical trial logistics. However, clinical ancillaries are transported through a different, but parallel, supply chain to drugs. This is partly for practical reasons; unlike drugs, clinical ancillaries do not need to go through temperature assured networks, so sending them through the same supply chain would be wasteful. Moreover, while clinical data and results from lab kits must be sent for analysis as quickly as possible, a lack of inventory control may mean that clinical ancillaries are often forgotten at the end of trials, ‘donated’ to hospitals, or disposed of in the clinic for want of a reverse logistics plan. Clinical ancillaries and lab kits are not managed with the same precise IT tools as drug supply, as they are viewed as less important and lower-value elements of the process. Yet in reality, ancillaries and lab kits can be as complex to manage as drugs. Ancillaries usually consist of a variety of stock-keeping units required at different stages of the trial, which are generally linked to the protocol in question; however, lab kits are similar to the trial medication, in that they are linked to the individual investigator sites’ patients and the patient visit cycle.

Clinical Ancillaries Management
This approach, so at odds with the tightly controlled environment of a clinical trial, has been adopted because clinical ancillaries and lab kits are usually managed by CROs (including labs) as a diversified service, rather than a core competency. They are an add-on which, at best, distracts from the team’s activities. As logistics accounts for around just two per cent of R&D budgets and clinical ancillaries an even smaller fraction, lost within the CRO’s charges, any apathy towards their transport is understandable. However, with R&D budgets under increasing pressure, even small savings add up. Well-managed clinical ancillary logistics delivers benefits far beyond the bottom line; it forms a key component in not only ensuring consistency, but in managing regulatory compliance and gaining investigator goodwill. These are two crucial components of managing trials, particularly in the developing world, which currently accounts for about 47 per cent of trials – a figure which is increasing all the time, according to DHL data. Many countries have complex customs restrictions on import and export. For example, in Argentina, there are strong incentives to buy locally; even bringing in large quantities of documents will incur heavy taxes. A dedicated logistics provider understands these rules and the most efficient way to navigate through them – sourcing food domestically for a trial, say, can save thousands of pounds in duties, as well as time. An understanding of local markets is crucial in managing global trials, and the local custom restrictions and regulatory environment that apply.

Timelines also vary; gaining approval and launching a trial may take three months in the US, but can take more than eight months in China or India.

When ‘donations’ to investigators involve valuable computer equipment, or even furniture, anti-bribery rules can suddenly rear their head. Forgetting, or not bothering, to ship a computer out of a country might be an innocent oversight, but it could end up costing a business millions of dollars in legal fees and potentially even its global reputation. With these rules varying wildly around the world, it is more important than ever to understand individual regulatory environments.

Hospitals and investigators are also likely to look more favourably on a pharmaceutical company that ensures deliveries are timely and reliable. When pharmaceutical and biotechnology firms are competing in similar therapeutic areas for the same investigators and their patient populations, having a slick and well-organised logistics operation may endear the company to investigators through improving the site experience. Inventory and transportation control is vital for trial success, both immediately and in the long-term.

Planned Approach

As an increasing number of clinical trials are taking place in emerging markets with challenging infrastructure, complex regulatory requirements and limited opportunities for domestic sourcing, so clinical ancillaries are becoming more complex to manage. To ensure consistency and overcome potential challenges, procurement managers are increasingly utilising networks of global depots run by a single provider that is able to take a holistic approach and focus on finding a cost-effective blend between central procurement and storage, and local storage and procurement.

A well-planned clinical ancillary management system consists of a carefully designed supply chain that streamlines costs through regular forecasting, mitigating risks, planning the correct use of carriers for the appropriate transport lanes, and consolidating items to reduce costs and environmental effects. Performance metrics are then used to measure the effectiveness of the strategies.

A defined plan will also ensure that clinical ancillaries are quickly and efficiently recovered at the end of studies and disposed of, donated, or reused as appropriate.

Logistics managers are implementing intricate technological solutions to track items globally, from depots to hospitals and, crucially, back again. Tools to forecast demand and calculate importation taxes and duties across the world are playing an increasingly important role in providing management information to make the right procurement decisions when purchasing ancillaries. Lab kit building software is also being developed to manage complex labelling requirements such as serial numbers linking sample containers to trials, sites, visits and patients. Lab kit production can then move to more ‘just in time’ production and distribution models, and become subject to the Lean or Six Sigma principles found in mature manufacturing operations. All of this has the potential to make trials run more smoothly, saving cost and ensuring trials are fully consistent and legitimate.

It is evident that clinical ancillary management is a logistics issue that can be solved by experts such as third-party logistics providers. Logisticians spend their lives simplifying supply chains, so they understand how to apply this expertise to clinical ancillaries, particularly as many are already experienced in managing coldchain supply chains for drugs. Currently, many trials are managed by completely different logistics providers, with one organisation handling drug supply, another dealing with ancillaries and occasionally a third company managing the lab kits. If CROs and labs were left to focus on what they do best – applying clinical expertise to ensure trials are correctly set up and analysed – logisticians could do the same. This would lead to benefits across the industry, from procurement managers to investigators to researchers – and even to patients.

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Alex Klim is a Development Manager for DHL Supply Chain’s Clinical Trials Logistics Service (CTL). His previous roles in DHL include implementing materials management programmes in UK hospitals, global depot setups and freight management. Alex has an MA in Logistics and Distribution from the University of Westminster, UK.
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