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C. Completeness of Results Database |
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To be able to provide a result for every protocolled test for every sample received would be ideal for both the investigator, concerned about patient welfare, and the trial biometrician. This ideal situation, while possible for Phase I trials performed in house, is rarely achievable for transported samples because of such factors as poor quality samples, samples too old for analysis, broken tubes or leaked samples. In assessing the frequency of no test result, 148,355 test requests for clinical chemistry, hematology or endocrine analyses, received over a 12 month period, were examined. A valid numeric result was reported for 98.3% of the tests requested. For the remaining 1.7% (i.e., 2,513 tests), where no result was possible, 70% related to hematology, mostly due to old or clotted samples, while lack of clinical chemistry results was usually due to broken or leaked tubes. |
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Irrespective of whether the laboratory charges the Medical Function (i.e., sponsor) for clinical trial support, the actual cost of performing the test and providing the total service has to be calculated and compared to external contract prices. In 1994 the laboratory commissioned Technomark Consulting Services Ltd to perform a survey of the clinical pathology pricing in the U.K. and the rest of Europe. Responses were received from 23 contract laboratories (14 from the U.K.) and each was requested to prepare costings for a Phase II trial with 50 investigators, 5,000 sample packs; to report the results and any analytical trends for 5,000 sample analyses for clinical chemistry; hematology, 4 hormones, and PSA as a tumor marker; and the electronic transfer of the data back to Zeneca. They were not requested to supply a cost for sample transport; for providing CRA monitoring of the centers, or perform any management of the trial data (i.e., demography checks and error corrections). |
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The survey shows there to be a wide variation in price between laboratories (Figure 8). The U.K. prices are on average lower than those in the rest of Europe, but the two ranges do overlap. The lowest price received was £117K, the highest £639K, a factor of 5.5 between lowest and highest. Within each individual category of analysis there was equally wide variation (clinical chemistry: £27.5K£169K; hematology: £14K£59K; endocrinology: £37.5K£360K, and PSA: £15K£121K); more remarkable were the charges for producing the reports ranging from £500 to £50,000 while the cost of supplying the sample packs ranged from as little as £0.08 to £20 each. |
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The Zeneca laboratory's costing for this trial was £213K (i.e., 6th lowest cost). |
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