Perceptive Informatics, a leading eClinical solutions provider and a subsidiary of PAREXEL International Corporation (NASDAQ: PRXL), announced that it is taking a lead role in the biopharmaceutical industry to advance the practical application of revised response criteria for Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL) to clinical trials. Bruce D. Cheson, M.D., Medical Imaging Scientific Advisor, Perceptive, who chairs the Lymphoma Committee of the Cancer and Leukemia Group B and American Joint Committee on Cancer (AJCC) Subcommittee on Lymphoma, is working with the Perceptive Medical Imaging Group on standardizing and harmonizing the criteria across investigative sites and central reviewers for the assessment of patients.
According to Dr. Cheson, "Perceptive is a leader in bringing practical approaches to the implementation of standardized guidelines for assessing response to treatment of hematologic malignancies. This major step is valuable to Perceptive's clients in their imaging-based oncology and hematology clinical trials, with regard to the application of the assessment criteria for NHL and CLL." Dr. Cheson is an author on the widely accepted assessment criteria for NHL (1999 and 2007 IWG-NHL) and CLL (1996 NCI-WG and 2008 IWCLL), which are standardized guidelines for assessing response to treatment.
Perceptive Informatics has introduced its NHL/CLL Product Program to support the implementation of these criteria in clinical trials. Dr. Cheson, Professor of Medicine, Deputy Chief, Division of Hematology-Oncology, and Head of Hematology at the Georgetown University Hospital Lombardi Comprehensive Cancer Center, together with the expert medical team in the Perceptive Medical Imaging Group are helping to advance understanding of the guidelines to provide clinicians worldwide with consistent criteria to compare and interpret clinical trials in hematology and oncology indications -- with the goal of facilitating the development of new treatments. Perceptive experts bring an in-depth understanding of the criteria for harmonization across clinical trials. Perceptive develops analysis applications to enhance the review process and workflow for studies using the NHL/CLL analysis criteria to validate clinical trial data.
The Perceptive whitepaper entitled "Recommendations for Implementing Assessment Criteria Guidelines in Lymphoma and Chronic Lymphocytic Leukemia Clinical Trials" provides clarifications for applying the revised criteria in clinical trials, with a particular emphasis on protocols and independent review analysis.
Source: International Corporation