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Strategies for labs to support global trials and meet the needs of sponsors worldwide.
A number of authors have recently estimated the expenditure in clinical trials for laboratory services to be above $1 billion (€750 million). Such laboratory services include preclinical and clinical lab testing as well as expenses for imaging techniques. It is envisioned that the proportion of this analytical budget spent at central laboratories in contrast to local laboratories will continue growing.
Whereas 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. These requirements seem to support the view that central laboratories in the future will be more "central" rather than a build up of lab affiliates in many geographic regions. Complex new methods can only be offered at competitive prices if samples are tested centrally in larger batches.
Investigators (and sponsors) expect lab results to be reported immediately after the central lab receives the samples. Result reporting within 12 to 24 hours may be easy to achieve for routine testing methods. Interestingly, for more complex and specialized methods, the frequency of running a specific assay in the laboratory directly depends on the number of samples received. The high cost of instrumentation (up to $250,000) and reagents ($1000 for a kit to test approximately 40 samples), in addition to the need for qualified technicians, explains why laboratories need a minimum batch size to offer competitive lab fees to sponsors.
A small laboratory processing 50 or 100 samples a day may only receive five to 10 samples for a specific immunology method. This imaginary laboratory would only be able to run the immunology assay two to three times a month at a rather high cost per unit. The chances are very high that small laboratories refer their samples to larger laboratories (often hospital-based laboratories with poor quality standards and missing cross-validation data). A central laboratory with the capability to process 5000 or more samples per day may have the advantage of both offering competitive prices and reporting lab results with the shortest delays.
When looking for a central laboratory, sponsors should therefore find out early on if candidates are not only able to perform the study-specific test panel but, more importantly, if they are able to perform the assays requested on a daily basis to ensure short result-reporting delays.
The geographic location of the study site is an important factor in the selection process when looking for a central laboratory. From a logistical point of view, it would not be a good idea to select a European central lab for a U.S. only study and then ship all samples over the Atlantic.
In view of the increasing number of studies with sites on two or more continents, sponsors are faced with the question: How much local and how much central? In contrast to CROs, a central laboratory should work as centralized as possible.
To be successful, central laboratories may only be global by following one of the following two strategies:
Both strategies require a similar effort in cross validating lab methods at each location in order to continuously monitor data comparability and identify the need for corrective measures.
Multicontinental studies provide the professionals involved with physical and practical limits. A key aspect for succeeding in such trials is the ability to communicate between different time zones without having to wait for the next day.
The ideal location of a globally active central laboratory would seem to be Europe, as it would be located in the geographic center between Californian Biotech clusters (eight to nine hours apart, and reachable after 4 p.m. Central European Time [CET]) and Southeast Asia or Australia (six to nine hours apart, and reachable before 10 a.m. CET). A further advantage for Europe is that South Africa is in the same time zone as continental Europe. Instead of sending emails or faxes and waiting until the next day for a response, a European central lab offers synchronic and interactive communication (e.g., via phone), which may ensure the shortest turn-around times.
In contrast, a company in New York must overcome the time difference of 12 or more hours between them and their clients in New Delhi, Hong Kong or Sidney. Also, the duration of travel flights seems to be shorter for Europeans: A nonstop flight to San Francisco or Beijing takes 11 to 13 hours. A flight from Singapore to New York needs a stop-over and takes 18 to 24 hours. In addition, within Europe most major European cities are within a radius of two to three hours from each other.
Fortunately, the need for central lab services will continue to grow. Central laboratories will be asked to develop more sophisticated methods and to extend their logistic infrastructure to new geographic regions.
In view of the reduced number of global central laboratories (less than a dozen) and the significant differences between them, I do not think the approach of having a master services agreement with two to three central laboratories is viable for the future for most sponsors. Smaller laboratories may be good for local studies where the testing portfolio is not too demanding, but they will not have the volume to cope with test panels that are becoming more complex. Larger central laboratories, following either strategy mentioned, may succeed in supporting global studies if they have an established worldwide infrastructure and a solid quality system in place.
Hermann Schulz, MD, FFPM, is chief executive officer and co-founder of INTERLAB Central Lab Services–Worldwide GmbH, Munich, Germany, email: info@INTERLAB.de