EPL, Inc - Pathology Peer Review

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Information about EPL, Inc - Pathology Peer Review
Health & Medicine

Published on February 18, 2014

Author: sandersp

Source: slideshare.net

Description

The main purpose of a Pathology Peer Review is to improve the quality of the pathology data and narrative. This can be achieved in several ways. A peer review can help to ensure that the data are presented in a manner that meets the requirements of the regulatory agency to which the data will be submitted. A peer review may help to increase the accuracy of the data, thus increasing the confidence in it both for the Sponsor and for the regulatory agencies. This is true whether the study was completed at the Sponsor’s facility, at a Contract Research Organization (CRO), or in an academic laboratory. A peer review can also confirm the target organs identified in the original evaluation and confirm the No Observed Effect Level (NOEL). Our unique PQA software program is a computerized pathology peer review procedure developed at EPL that operates on a portable laptop computer. Study data can be interfaced between the laboratory and EPL’s pathology peer review program through the use of electronic ASCII text files. This assures that the accuracy of the data is maintained during the entire review process and that comparison between the preliminary histopathology data from the laboratory and the pathology quality assurance audit can be made rapidly. In this manner, differences can be easily identified and resolved by the study pathologist and reviewing pathologist, thus allowing the laboratory to complete the draft study report in a timely manner.

Peer review also serves as a source of continuing education and training, for both the study pathologist and the reviewing pathologist. In many cases the study pathologist will have a limited amount of experience, and can benefit from the broader range of experience of the reviewing pathologist. On the other hand, the reviewing pathologist almost always sees something new and learns something different during every peer review. EPL’s team of experienced pathologists have been providing peer review services to the NCI/NTP carcinogenesis testing program and commercially for companies in the pharmaceutical, biotechnology and chemical industry for over 30 years. We provide these services to clients in North America, Europe and Asia. When conducting a peer review, we take our team to the testing laboratory where the study pathologist is located. This eliminates the cost and risk associate with shipping the glass microscope slides and by working directly with the study pathologist to finalize the findings speeds up the reporting process.

Experimental Pathology Laboratories, Inc. Pathology Peer Review

Reasons for Pathology Peer Review        Ensure data meets requirements of regulatory agencies Increase accuracy of data Increase confidence in data Confirm target organs Confirm no effect level (NOEL)/ No adverse effect level (NOAEL) Ensure consistency of diagnoses within the study Continuing education

Pathology Peer Review • • • • Performed by a second pathologist Routinely performed by many companies May also be done to address specific issues Involves a subset of tissues from initial evaluation

Things a Peer Review is NOT • A re-read of a study • Does not generate a second data-set • A “blinded” re-examination • A performance review of the Study Pathologist

Third-Party Peer Review • Advantages of a third party peer review: – Independent – less likely to be perceived as exerting undue Sponsor influence – Often more experienced – may have seen similar changes with related compounds – Less of a threat to the Study Pathologist – changes to data often less contentious

Typical EPL SOPs • Rodents – Subchronic: • Complete Review (CR) of 20% of control and 60% of highdose groups • Targets: all animals, all dose groups • Proliferative changes: all animals, all dose groups – Chronic • Complete Review (CR) of 20% of control and 60% of highdose groups • Targets: all animals, all dose groups • Proliferative changes: all animals, all dose groups

Typical EPL SOPs • Dogs • Complete Review (CR) - 25% of control and 75% of highdose groups • Targets: all animals, all dose groups • Proliferative changes: all animals, all dose groups • Non-human Primates • Complete Review (CR) - 25% of control and 100% of highdose groups • Targets: all animals, all dose groups • Proliferative changes: all animals, all dose groups

Reconciliation • Following the review, the Study Pathologist and Reviewing Pathologist discuss all differences of opinion and arrive at a mutual consensus diagnosis • The Study Pathologist then modifies the data set and report as needed • The new data/report is reviewed by the Reviewing Pathologist • When the pathology report is finalized (signed), the Reviewing Pathologist signs the Peer Review Statement

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