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| Pathology Peer Review Peer-review is essential for validation of results derived from the art of pathology. Although there has been considerable debate as to whether slides should be evaluated using blind or open identification, peer-review is a validation step that all agree upon. The consensus position of pathologists is that studies should be read knowing the treatments, and then if lesions are questionable, reread the slides blind, or without knowledge of treatment groups. Informal peer-review entails an ad hoc review of some slides, or a specific lesion, which the pathologist is uncertain how to classify. This second view either confirms the primary pathologist’s view or leads to a reevaluation of those slides demonstrating the lesion Formal peer-review is in many ways a quality assurance process. It typically involves reevaluating about 20 percent of the slides that are randomly selected. Diagnoses are reviewed for correctness, consistency, and some quality control aspects. An example is the review of slides for missing tissues. Occasionally, small tissues, such as parathyroids or lymph nodes, are recorded as normal by the pathologist when they were actually missing or vice versa. Re-examination of the slides for the missing tissue is the only way to determine whether a tissue is present or not. This type of error can only be recognized and corrected during a peer-review. The method of formal peer-review varies among laboratories; however, there are a number of steps taken by all who use this formal process. The peer-review pathologist reviews a sample of slides and checks them against the primary pathologist's diagnoses. The peer-review pathologist and the primary pathologist then discuss differences until agreement is reached. There are many advantages to using Walker Downey & Associates to conduct third-party peer review for your studies whether conducted at your facility or at a Contract Research Organization (CRO). The added value to the study when it reaches the regulatory agencies in the United States, Europe, or Japan include increased credibility with reviewers, increased confidence by the study sponsor, increased accuracy of the data, and potentially reduced scrutiny of the pathology report by the reviewing agency’s compliance groups. This should result in reduced time to gain regulatory approval of your studies and allow a faster return on your investment. Currently, peer review is required by regulation only by a few agencies. The US EPA requires peer review on all submissions requesting re-consideration of carcinogenicity peer review decisions based on changes in the pathology diagnoses. Additionally, peer review is required for all carcinogenicity studies submitted to the European Agency for the Evaluation of Medicinal Products. While not required by FDA and other regulatory authorities, it is generally recognized that the reliability of pathology diagnoses is greatly enhanced by comprehensive quality assurance and peer review. Walker Downey & Associates, Inc. stands ready to help you in your pathology peer review process. Contact us at info@walkerdowney.com to discuss how we may strengthen your evidence-based documentation for product safety and development.
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