Collecting and processing some of the most advanced research and clinical trial data in pediatric oncology requires efficient coordination and collaboration. We have streamlined our most common operational processes, like protocol review and management, budgeting, and contracting. This has allowed us to open studies more quickly and to focus more on our patients and research.
The POETIC Data and Coordinating Center, is located at Memorial Sloan Kettering Cancer Center (MSK) in the Compliance Division of Clinical Research Administration. We provide a full-service suite of oversight for all clinical trial start-up and coordination between member sites and industry sponsors, including protocol management, data monitoring, data reporting, study compliance, and regulatory management of clinical trials. This centralized approach streamlines the protocol review and activation timeline, getting novel clinical trials to more patients, sooner.
The DCC works directly with investigators and research staff at all levels to facilitate study review and coordinate resource management of clinical trials. This working relationship encourages long-term engagement, and enhances our knowledge of each site’s start-up process and timelines. Our experience managing both investigator and industry sponsored clinical trials enables us to uniquely evaluate study feasibility and scope within the consortium for each clinical trial.
Clinical trial oversight is conducted by the Protocol Chair/PI, The POETIC Director, Institutional Review Boards, Clinical Research Program Director, and Data and Safety and Monitoring Committee at MSK. On-going data monitoring is conducted by the POETIC DCC research staff from the start of the study. We utilize a matrix review platform for each project, consisting of POETIC committee review, institutional oversight, and input from scientific advisory boards and physicians.
In addition to trial start-up and study monitoring, the DCC also manages all contracting and budgeting activities for each clinical study on behalf of the POETIC Consortium. This centralized contracting and budgeting schema allows for a more streamlined protocol activation process, removing some of the common bottlenecks to study activation.
All POETIC institutions comply with common principles of clinical trial conduct, good clinical practice, and authorship guidelines.