| Dr Hermann Schulz of INTERLAB central lab services underlines the central laboratory’s changing role in the outsourcing market
In his recent papers (1,2,3) EPC’s Editor, Graham Hughes, has estimated the central laboratories expenditure in clinical trials to be around 10 per cent of the global R&D budget of US$13 billion (ˆ10 billion). In this prediction, he envisions that clinical trials will grow in terms of complexity, size and diversity, giving reason to the expectation of business for the central laboratories to increase. Whilst CROs expand into geographical regions where running clinical trials at a lower cost is feasible, laboratories are asked to perform more complex – and expensive – methods or to validate new assays specifically for one sponsor. This leads to the optimistic vision that the growth of central laboratories will surpass the double-digit growth expected for CROs. The question is: will a specific type of central laboratory take the most advantage of this market development?
A CENTRAL LABORATORY IS A LOGISTICS EXPERT
A number of publications have described the advantages of using central laboratories (4,5). Clinical teams at pharmaceutical and biotech companies have learnt that a central laboratory needs time to prepare the complex logistics associated with a multicentre trial. When asked to define logistics, many clinical research professionals only refer to shipping and transportation aspects. This is a very interesting survey outcome, and people are often surprised when they realise how complex the logistical task of a central laboratory is. Table 1 (see page 116), shows key aspects related to logistics in clinical research.
Study-specific laboratory materials and instructions have to be sent to all sites well in advance in order to allow them to be prepared for their first patients. Investigator manuals should be written in the local language and shipping documentation must reflect the needs and requirements of local customs and transportation regulations.
Most countries outside the EU request proforma invoices and shipper’s declarations which should be pre-printed and describe the content of each package in sufficient detail. Instructions to the sites should be kept to a minimum in order to ensure that investigators and study nurses are able to comply with them. General comments should be avoided; instead, only study-specific instructions should be provided. Clinical monitors or CRAs should find out during their study initiation visits if each site has sufficient storage space for the study materials and the visit specific kits provided by the central laboratory. A further logistical aspect is monitoring the stability of the materials provided to each site and ensuring automatic resupplies before their expiration. |
