Multicenter Protocol Management at a Large Comprehensive Cancer Center


Abstract Description
In 2009, the Office of Clinical Research (OCR) at Memorial Sloan-Kettering Cancer Center created a group dedicated to multicenter trials (MCTs) where the institution is the sponsor and/or data coordinating center and external sites accrue participants. The Office compiled best practices, established an institutional policy, monitored policy compliance, and conducted standardized trainings to the staff implementing the MCTs. 

Since that time, the number of MCTs has doubled, and the MCT Office has expanded in size and scope. As of March 1, 2015, there were 130 active MCTs spanning eight clinical departments, and including 237 sites. 

New initiatives to meet the increasing growth and complexity of MCTs include: (1) the establishment of the Multicenter Protocol Executive Committee (MPEC) in 2014, which is an institutional committee whose primary function is to review and approve complex MCTs before they enter the formal protocol review process. MPEC review is required for MCTs where: the institution holds or cross-references the Investigational New Drug/ Investigational Device Exemption, international sites will accrue, and/or more than five sites will accrue. The committee is comprised of various clinical research stakeholders. Reviewing proposals early on helps ensure logistical feasibility and resource availability. (2) The Multi-Site Research website, created with the Technology Exchange Core in the OCR, was launched in August 2014. Staff at participating institutions receive a login and password that provide access to a dedicated study webpage. The webpage, maintained by the MCT Office, allows the institution to distribute IRB approved protocol documents, training slides, and other study specific material. Emails can be sent to defined groups to alert users to important announcements (e.g., cohort availability, posting of new documents). This innovation decreases email traffic and streamlines communication away from individual email accounts. Future plans include the ability to securely post PHI (e.g., safety reports) to the website. (3) The transfer of MCTs from the Department of Medicine (N=35) to the MCT Office on January 1, 2015. Whereas, previously, study implementation was done solely by the clinical departments, the MCT Office now has two subparts: one that focuses on institutional policy and one that conducts the studies. The change has eliminated redundancies of research staff. In the new paradigm, quality assurance is handled uniformly between the institution and the external sites to ensure consistent standards and protocol conduct. Budget and protocol development are streamlined, saving time and effort. Ultimately, the management of all MCTs across the institution will be centralized in order to concentrate expertise and realize the most efficient processes possible.