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also potentially mask adverse clinical pathology changes related to the administration of the new drug entity. |
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Logistical difficulties for the sponsor relate to the need to audit several laboratories to ensure compliance with GCP, including the local archiving of raw data. Electronic transfer of laboratory results from local laboratories to the sponsor is uncommon, resulting in labor intensive manual data entry, data checking, and validation; all of which add time and additional resource to the completion of the clinical trial and the reporting process. |
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C. Views of Sponsors on the Use of Central Laboratories |
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Current trends in pharmaceutical clinical trial management have forced many companies to use central laboratories because multicenter Phase II and III trials are becoming increasingly global in scope and larger in scale. These trials often entail novel therapeutic agents for which special or experimental assays are needed to demonstrate safety and efficacy. While there may be some reluctance on the part of investigators to move away from the use of local laboratories, the benefits of using a central laboratory to the sponsor and thus to the overall cost effectiveness of the trial are persuasive. |
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There is little doubt that the data consistency obtained by analysing 100,000 samples at one central laboratory is significantly superior to that for 1,000 samples analysed at 100 laboratories. It is also believed that regulatory approval is much easier if a higher proportion of results are obtained from the same laboratory. In order to achieve this advantage the central laboratory must guarantee standardization of its methodology and analytical procedures and compliance with the European Union's GCP guidelines and the principles of GLP. For logistical reasons there may be more than one central laboratory located in different countries but the standards and principles they work to have to be identical. Several large clinical Research Organizations are structured in this manner and they guarantee global consistency with single methodology, instrument type, reporting format, etc. for all their central laboratories, throughout the course of a trial. Combining or merging of laboratory data from multiple central laboratories and across multiple trials, in order to establish a longitudinal safety and efficacy database, becomes feasible and highly desirable. |
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The quantity of clinical pathology data produced during a multicenter multinational trial is significant and the speed and efficiency with which it can be assembled, interpreted, and reported are becoming more critical as the pressures increase on pharmaceutical companies to contain development costs and progress drugs rapidly to the market. Rapid access to data is no longer a luxury but an absolute necessity allowing the interim assessment of safety and efficacy. Therefore, the efficient electronic transfer of laboratory data to the sponsor is essential to reduce cost and time by eliminating hours spent tran- |
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