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whole trial to a CRO who will establish working relationships with one or more clinical pathology laboratories. Over the past few years we have seen in Europe more complex relationships being established between sponsor, one or more CROs responsible for managing the trials, a separate CRO responsible for data management and a central laboratory with links to a specialist laboratory. Traditionally CROs were mainly used for study monitoring and local recruitment for the Phase III/IIIb and Phase IV trials. In a recent survey of CRO usage, Getz and Vogel [7], it was noted that use of CROs for Phase II work had not increased between 1992 and 1994 and remained at about 16%. The use of CROs for study monitoring had increased from 59% to 94% but significantly more CROs were used for data management (from 5% to 94%) and statistical analyses (from 10% to 77%). In this survey, 64% of companies said they gave major project responsibilities to more than eight CROs at any one time. The other 6 said they preferred to use a limited number of CROs. |
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A sponsor who has developed a good working relationship with a particular central laboratory should think very carefully before contracting additional partners. Such relationships are based on mutual understanding and trust, underpinned by good communication. Central laboratory personnel should be involved with the pretrial meeting with the sponsor to review and resolve any outstanding issues before the trial begins. Attendance at the pretrial investigator meeting is mutually beneficial for the laboratory personnel to gain a better understanding of the aims and design of the trial and for the investigator to meet and communicate with the individual who will be providing their test results. |
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When using a laboratory for the first time the sponsor should identify individuals who will interface directly with designated personnel at the central laboratory. These individuals should allow plenty of time to get to know their counterparts and should arrange a laboratory tour to get to know and understand the laboratory's procedures (e.g., sample tracking, report formats, barcoding, etc.). Ideally, the sponsor's representatives, possibly a CRA, should personally get to know the study director at the laboratory; the data management staff both at the laboratory and in-house; the QA/QC people both at the laboratory and in-house; and the laboratory management in order to ensure appropriate resources are available for the laboratory to support the trial and to resolve any problems. At this stage it is also appropriate for members of the sponsor's Quality Assurance group to check laboratory procedures. |
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B. Operational Pretrial Checks at Central Laboratories |
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It must be remembered that, although time is money, adequate time not spent setting up a trial properly can cost even more time and money later. |
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