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Preclinical CRO: Ensure your Pathology Report is On Time and On Budget

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Preparing a high quality pathology report is the essential step to ensuring the success of your preclinical study. The pathology report, prepared by a board-certified veterinary pathologist, will include an accurate description of what effects he or she is seeing from the test article.  This description will allow your sponsor to move forward in their research endeavors by giving them the critical data they need in order to proceed accordingly.

How can you ensure the delivery of an accurate and comprehensive pathology report in a timely and cost-effective manner?

  1. Study protocol  

In order to ensure the pathologist understands the scope of work for the histopathology portion of the study, it is imperative that there be a clear directive for the pathology evaluation in the study protocol. It's also vital that the study director is communicating his or her needs and expectations effectively from the very beginning. Being as specific as possible in the study protocol is a sure-fire way to achieve this.

Verify that the pathologist you are working with has relevant experience with the scope of work outlined in your study protocol particularly in the following areas:

  • Animal model/strain
  • Route of exposure
  • Study design
  • Tissue list
  1. Selecting a contract pathology laboratory

Taking the time to do your due diligence when selecting a pathologist to evaluate your study will save both time and money in the long run.

  • What is the customer service reputation of the contract pathology laboratory(ies) that you are considering?
  • Do they communicate with you in a timely and thorough manner during the inquiry phase?
  • Do they have extensive familiarity with GLPs?
  • Have they worked with your particular animal model/strain?

These are some of the key questions that you can ask at the onset that will give an impression of the communication style and level of quality you can expect from the contract laboratory.

  1. Conveying expectations

Detailed and clear dissemination of expectations will also make a huge impact both on the quality and timeliness of the study results. Although there has been some controversy about divulging expected results prior to slide evaluation, the Society of Toxicologic Pathologists (STP) recommends that all study data be made available to the pathologist prior to analysis, including:

  • Intended pharmacologic target and mechanism of action
  • In-life study data
  • Clinical pathology data
  • Organ weight data
  • Necropsy findings
  • Toxicokinetic information
  • Data from previous studies with the same test article (when possible)  

This allows for the most comprehensive interpretation of the data and for identification of subtle changes caused by the experimental agent.

  1. Defining roles and responsibilities

Finally, it is crucial that the responsibilities of the pathologist be clear from the start. The study pathologist’s responsibilities include:

  • Evaluating all tissues from specific groups (as outlined in the protocol)
  • Reviewing all pathology data
  • Writing the pathology report
  • Collaborating with the study director, sponsor and other scientists involved to sign the final pathology report

A missed opportunity now could cost both time and money later. Safeguard the integrity of your results by asking your contract histopathology laboratory the right questions upfront. Make sure that the study pathologist is qualified and prepared to evaluate the slides and write in a timely and professional manner. Ensuring that your preclinical research reports are accurate and of the highest quality provides the foundation for clinical success.

Sample Pathology Report from HSRL

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