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    • Oncology Studies and the Shift to a Centralized Lab Approach

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      Published On Jan 28 2013, 2:39 AM

      Oncology Studies and the Shift to a Centralized Lab Approach Last month I was interviewed by ClinicalLeader for an article about how the central laboratory approach, as opposed to the traditional, distributed model of clinical trial lab testing, is driving higher quality and efficiency in clinical drug development. The article highlighted Covance Central Laboratory Services (Covance CLS) as an example for the new model emerging - using advanced technologies and global operations to concentrate all clinical trial tests into a single, central laboratory. The article also addressed how and why the industry is beginning to adopt central laboratory services for oncology studies.

      Combinable Data: The Core Value of a Centralized Approach

      Consistency is the core value of a central lab. When local laboratories perform testing, their results will be different. On the other hand, what a central lab provides is 'combinable data.' For instance, in all of Covance's laboratories - in Indianapolis, Geneva, Singapore, Shanghai, and Tokyo - when we do a test, we use the same method platform, and we correlate and standardize the results between all of our labs. The end product is that if you look at a test result from any of our laboratories, you cannot tell which one it came from.

      Less variation in results also makes it easier for trial sponsors to assemble meaningful statistics, which in the end are easier to defend to regulatory agencies. For instance, the FDA and EMEA have seen Covance's central lab data for more than 20 years and they have never found fault with the idea of testing centrally.

      Standardized Sample Collection Kits Drive Consistency

      Another way we eliminate variables from the testing environment here at Covance CLS is via standardized sample collection kits, which we designed in-house. Our specimen collection kits contain every useful article necessary to obtain specimens globally and ship them back to Covance.

      In each kit, the tests and collection components are specific to the particular patient visit - from screening at the first visit, through all other visits from the remainder of the trial. There are also special kits for the remainder of the trial. There are also special kits for retests, end-of-trial activities, and anatomic pathology services. This is difficult for a local lab to achieve for global clinical trials because that lab will only serve their local population.

      Another way we optimize specimen collection at Covance CLS is by ensuring investigator site staff are trained in handling specimens so the trial can begin enrolling with minimum delay, reach its budget milestones, and deliver the required data by meeting the unique needs of each protocol. We created a document at Covance CLS that encourages the investigator to contact and engage with the source laboratory and its pathologist to help select the tissue block that contains the best target. This document, which is personalized to each study, includes directions for identifying specimens that either lack the target tissue or contain it.

      Digital Imaging: The Wave of the Future

      The ClinicalLeader article pointed out that "distance could be the nemesis of central anatomical testing, were it not for extraordinary yet reliable coordination of transport, communication, and now Covance CLS' ability to perform "target enrichment" through digital imaging.

      The economics of anatomic pathology specimens is quite different from clinical pathology specimens. You can go back and you can collect urine, blood, plasma, serum, and even collect things like cerebral spinal fluid, but you can't go back and recollect biopsy samples. For that reason, they are at particular risk of being lost. That's why digital imaging is the way to go.

      Digital pathology helps speed trial enrollment through quicker and more accurate target lesion identification for inclusion/exclusion of study subjects. Turn-around time can be reduced by one or two days, plus risk is reduced from not having to ship fragile glass slides, and costs are reduced because no shipping of samples is required. Overall, global consistency in data is improved due to more uniform global turnaround time from sample collection to tissue processing, as well as enabling a single reviewer, globally, to perform analysis on all slides, without concern about where in the world the slides originated.

      Central Labs and Oncology Trials

      Oncology trials, by their very nature, use nearly every kind of test and specimen possible, which is driving the industry to slowly adopt a centralized approach for oncology studies. Three main forces are at a play that will determine the pace of further progress: international harmonization of clinical development, growth of global trials, and the progress of cancer research. In addition, the increased analysis of "biomarkers" in cancer research and greater regulatory pressure for global data compatibility will also be key factors.

      However, as cited in the ClinicalLeader article "industry resistance to the central model persists." ClinicalLeader also points out that a traditional argument for the use of local laboratories for oncology studies is patient safety and dosing. However, the central lab's quick turnaround of data actually enhances safety, speed dosing adjustments, and facilitates other needed changes to the trial. For instance, Covance's Central Laboratory Services can supply safety data to the investigator and sponsor in 24 to 48 hours.

      Drugs in oncology studies are themselves toxins. Therefore, if you're looking at local laboratory data for patient safety and dosing, the variability in data from one locale to the next means that patients will be receiving different doses in different locations. This would actually increase the complexity of data interpretation for the sponsor later in the study.

      Nonetheless, the industry's use of local labs is still more common than its use of central laboratory services for oncology specifically. ClinicalLeader states that on the global regulatory and clinical development fronts, the trends clearly favor the central lab model; however, the direction for oncology is less linear. The article attributes this to biomarker-driven personalized medicine realizing its limits just as other approaches, such as immunotherapy and a realization of environmental factors, are on the rise.

      Covance CLS assists or improves the clinical trial process for oncology studies in several main ways:

      • Globally uniform sample collection kits, customized to each trial and paired with logistics support services, to ensure irreplaceable tissue biopsies arrive at the laboratories in optimum time and condition.
      • Specimen management services to allocate and track patient tissue block samples through each step with barricades, regardless of sectioning type or placement on slides or in tubes.
      • "Target enrichment" of anatomical specimens, such as tumor tissue, through digital imaging.

      Central labs in general, and Covance CLS specifically, also add some major advantages to patient recruitment for oncology studies. In a study conducted and fully funded by the Life Science Strategy Group (LSSG), an independent market research and consulting firm based in Menlo Park, California, 552 clinical trial investigators around the world were polled on the impact of their relationship with a central laboratory on their overall job satisfaction; 87% said they are "more satisfied and willing to work with a pharmaceutical sponsor on future clinical trials when they have selected my preferred central laboratory."

      In the same study, when asked which central lab they most prefer to work with, 54% of the investigators said Covance - a percentage three times higher than for the nearest competitor. In general, investigators rated Covance CLS the highest in investigator training, customer service, and kit management.

      You can read the ClinicalLeader article for more insight into the adoption of the centralized lab for oncology studies, as well as the overall shift from a localized to centralized lab approach.

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      About Dr. John Laczin
      John Laczin, M.D., FCAP, is Director of Medical Affairs at Covance, leading the Anatomic Pathology Histology Department of Covance's Central Laboratory Services. Before joining Covance as a pathologist in 1997, Laczin was director of a mid-size regional reference laboratory in upstate New York, where he started a clinical trials division.

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