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change reporting units due to new equipment. The laboratory data, therefore, has to be checked against more than 130 corresponding sets of laboratory ranges; in eradicating the bulk of these ranges by the use of a central laboratory, the total number of queries sent to a center can be drastically reduced. |
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As experienced by Fenning [5] laboratory queries amounted to as much as 46.5% of total queries in one multicenter trial using over 12 individual laboratories, and the total duration of the query process was 89 working days. |
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3. Retrieval of Data Timings |
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If a central laboratory is used, then retrieval and analysis becomes a single process, with no need to convert units or examine against separate reference ranges. The safety and efficacy profiles become simpler to understand because all parameters have been measured by the same method with the same units and compared against the same reference range. There are more options and more statistical power in this greater pool of results. |
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With the central laboratory there is no need to program each center's results with their related units into their individual tables. Consistency of the data set will require less data manipulation, important with the move towards electronic CANDAs. |
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B. Hidden Cost Benefit Associated with Reduced Development Time |
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When comparing the cost of different laboratories sufficient account should be taken of the real value of using a central laboratory as compared with local laboratories. In the worst case scenario, if it is not possible to merge the data obtained from the different laboratories, resolving the problem can add months to the development process at a very high price? The hidden cost benefit of using a central laboratory is evident in the time saved to get to the marketplace: each day potentially representing a million dollars in sales. A full cost benefit analysis should, therefore, include the time that is saved by achieving an earlier market launch of a new product associated with improved efficiency and a more reliable regulatory package. |
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Placing a figure on this saving is not easy since many factors influence the speed at which a trial can be completed and reported (e.g., the priority assigned to the trial). For a drug with a yearly return of $100 million, a saving of a few weeks for a pivotal trial on the critical path in a drug development program can amount to several million dollars. The time saving due to improved data management associated with the use of a central laboratory is considered to be in the order of 1015%. |
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