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laboratories can offer real-time, online access to national, pannational and global trial data providing a worldwide combinable trial database, national and remote safety reporting, and worldwide protocol management. When using such laboratories the sponsor should ensure that the same instrumentation and reagents are being used throughout the study and that the same methods, and even the reagent lots, are used at all the CRO's facilities. |
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In a survey conducted by Odel et al. [2], based on 27 clinical research decision makers, there was a difference in the usage of the three main types of laboratory (local, regional, or central) depending whether the relationship was with a pharmaceutical sponsor or a CRO. The pharmaceutical sponsor favored the use of local laboratories at the expense of using a central laboratory while the reverse was the case for CROs. |
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| | Percent Laboratory Utilization |
| | Local Labs | Regional Labs | Central Lab | | By Pharmaceutical Sponsor | | | | | By CRO | | | |
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From both the investigator's and sponsor's point of view, the patient's welfare and management needs are paramount. It may, therefore, be preferable to use a local laboratory when the study involves treatment of some acute disorders in which rapid turnaround time for tests may be necessary for directing patient care (e.g., for chemotherapy patients where the dose depends on the hematology results). Another situation where the use of local laboratories for routine analysis is preferable is in the treatment of critical care patients (e.g., clinical trials with antibiotics or anesthetics). Similarly, if a patient becomes acutely ill on a trial then a local laboratory should be used ideally with back-up samples being sent to the central laboratory to maintain the database without compromising patient care. Routine analyses should be done at the local laboratory but more specialized tests should be performed by the laboratory contracted to support the trial. It must be stated in the protocol how this data is to be handled and whether it will be included in the clinical trial database. |
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Within Europe, custom and practice may also influence the decision as to the type of laboratory to be used. In France, for example, there are more than 3000 private laboratories, and many general practitioners involved with Phase IV studies provide patients with a test request and entrust them to visit the local laboratory of their choice. The laboratory sends the results back to the investigator, who also receives a percentage of the fee charged for the analysis. Furthermore, many French GPs have no facilities for taking blood samples and these investigators often make it a precondition that the central laboratory |
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