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guardians of the data and will manage it on behalf of their sponsors. Sophisticated data management tools will aid global data review and trend analysis, providing the sponsor with the means to detect adverse events and monitor drug efficacy. Direct access for investigators to assess their own data will become mandatory, thus resolving many issues related to turnaround times and errors associated with patient or visit mis-identity and CRF transcription. |
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As the influence of central laboratories on the drug development process increases it will become more and more critical that these CROs respond to the needs of the sponsor. Greater flexibility for data management, customized reporting, and data transfer will become the norm and the central laboratory may need to take responsibility for management of locally derived laboratory data. Surrogate markers and novel assays, not commonly associated with clinical pathology, will need to be embraced with enthusiasm, thus relieving the sponsor of the responsibility of finding a reliable alternative that has the required expertise and credibility to perform the assay. Partnerships will probably become more common as CROs seek preferred supplier status. |
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The Zeneca laboratory is not seeking to expand its support of Zeneca clinical trials outside Europe and is not seeking to offer its services to other pharmaceutical companies. The cost benefit of the laboratory depends on a delicate balance between animal toxicology and clinical trial support. Any increase in the latter, demanding additional resources, or compromising the ability of the laboratory to effectively analyse toxicology samples would disturb such a balance. As clinical trials become more global it would be of benefit to both Zeneca and the laboratory to achieve an integration of its European database with that produced by a CRO prepared to support Zeneca trials in the rest of the world. Such an approach would allow our investigators to have direct access to their own data and allow them interrogation of the database. More importantly, it would allow Zeneca to reap the benefit of conducting unified global clinical drug development programs. |
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This chapter is dedicated to the memory of my uncle, Ellis Jones of Blaenau Ffestiniog, a gentle and caring person who fell ill during the preparation of this chapter and died on the day it was completed. [D.D.] |
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Mwyach ni chawn dramwy'r llwybrau,
Drwy y grug i'r llynnoedd pell,
Camu wnaethost, gyfaill annwyl,
Tros y ffin i fyd sydd well. |
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J. D. R. |
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