Ontario Clinical Oncology Group (OCOG)

Department of Oncology, McMaster University

The Ontario Clinical Oncology Group (OCOG) – Division of Thrombosis, at the Juravinski Hospital Research Centre at McMaster University in Hamilton, Ontario (Canada), serves as the Data Coordinating Center (DCC) for the C-TRACT Trial. OCOG is renowned for its high level of specialized expertise with the coordination of DVT trials. In recent years, the following completed or ongoing multicenter DVT studies have been coordinated by OCOG: ATTRACT, ELATE, DIRECT, SELECT, FLUTE, CANPEDS, LAFIT, D-d RCT, FIDO, PPS, CLOT, SIMPLE, MDA-DVT, SOFAST, PAPRE, 4D DVT, PEGED, DODS, and RASET. Of the six randomized treatment trials whose results have been submitted for publication, five (LAFIT, ELATE, CLOT, PAPRE, and ATTRACT) were published in the New England Journal of Medicine. In addition to its outstanding biostatistical expertise, the OCOG is experienced with quantitative venogram and clinical events adjudication in DVT.

In C-TRACT, the DCC’s primary function is to centrally coordinate the data management for the study. The DCC will work with the CCC to monitor study execution and protocol adherence; coordinate the web-based randomization and online data entry processes; collect, review, and verify submitted study data; develop and maintain the study database; coordinate data processing and quality assurance; create the DCC sections of the Manual of Procedures and other study materials; prepare summary information and reports for the various study committees, DSMB, and NHLBI; and perform the final data analysis for the study. The DCC will keep the Steering and Operations Committees apprised of progress and problems, prepare monthly status reports, and act as the Secretariat for the Independent Central Adjudication Committee (ICAC).