Retrieval and managementof clinical laboratory data

Pressure on companies to deliver accurate and uniform clinical laboratory data has caused a significant growthof the use of central laboratories for clinical trials.Jaap H M Dijkman reports.

Over the past decade, registration authorities have increased their pressure on companies to deliver accurate and uniform clinical laboratory data. At the same time pharmaceutical companies were calling for real-time access to and therewith more control over laboratory data. While central laboratories offered the solutions companies were looking for, there was increasing concern over new issues related to the approach used by central laboratories. Concerns included:

1. Delays in specimen result turn around time (TAT) in excess of 24 hours with associated stability problems.

2. Complex and expensive sample transportation with associated loss of samples.

3. Site management problems, encompassing a/o stability monitoring of and space allocation to specimen transportation kits.

This has resulted in a new approach to accomplish the same goal, but with elimination of these disadvantages: the Virtual Central Laboratory. Key to the this concept is the use of testing facilities at or close to the investigator's site, thereby eliminating transportation issues and TAT delays. The performance of these sites is closely monitored, following GCP/ICH-4 regulations, which eliminates site management problems.

Standardisation of the data-set

Laboratory testing at multiple sites requires standardisation of results in order to provide the same comparability of results as central laboratories offer, since their samples are analysed on single or cross-calibrated instruments. Following this procedure, anetwork VCL labs' will be calibrated, so that all results are reported according to the chosen reference method. Validity of the applied conversion factors is monitored by regular check-ups and daily QC monitoring. The conversion method is fully validated and the Dutch registration authorities have provided a statement of consent.

In addition VCL has serviced a number of phase II/III projects for which registration files will be submitted. The standardisation method applies to clinical chemistry safety measurements. Routine haematology testing can be pooled with acceptable variations. Esoteric tests are transported in batch to a central laboratory or ­ depending on utilisation ­ performed locally without standardisation. These procedures will markedly reduce sample transport in almost every project, while transport of esoteric specimens is better controlled with pre-defined pick-up and delivery schedules.

Local results will be entered in remote data entry software, VCLBase by the laboratory technicians. Upon entry, the data are transferred to the VCL database in Zeist, which immediately releases a study specific report by fax to the investigator. IT features to effectively manage projects, such as customised delta and alert flags, real-time reporting, electronic data transfer links, hard-copy reporting on NCR paper are all pre-defined in the database and can be customised on a project by project basis.

Because the results are available within minutes after their release in the local laboratory, the result turn-around time is as fast as a locally generated result, hence for safety within 24 hours after the sample is drawn. The latter is an important advantage in studies where TAT is critical, eg oncology or transplantation.

VCL monitors monitors the network laboratories on a regular basis with both by telephone and by site visits. At these visits compliance with the project laboratory protocol is monitored, a.o. adequate use of the standardisation method. The monitors also collect source data, which are archived by VCL following the ICH-4 regulations. Site monitoring ensures a smooth, GCP compliant process at the investigative site with minimal error in sample handling and patient identification.

In conclusion

The VCL approach is to utilise the advantages of central laboratories, while still making use of local laboratories. Since its foundation in September 1995, VCL has serviced more than 40 projects in more than 20 different countries in Europe for more than 25 clients. The favourable response of the clients has recently resulted in substantial new investments in the company to support commitment to large international studies.

Enquiry No 49

Jaap H M Dijkman is managing director, Virtual Central Laboratory International, Zeist, The Netherlands.

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