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.
Specialized or esoteric methods
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.
Geographic distribution
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:
- Having at least two major laboratories (e.g., in North America and Europe) and a number of smaller administrative subsidiaries
- Creating global networks of independent laboratories following the same global SOPs and using the same IT platform and database.
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.
A geo-strategic evaluation
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.
