Administration of the Immune Mediated Disorders after Allogeneic HCT Rare Diseases Clinical Research Consortium (RDCRC) will be based at the Fred Hutchinson Cancer Research Center. The PI for the program, Dr. Stephanie J. Lee, MD MPH, and the Co-Pi, Dr. Paul Martin, MD, are responsible for the overall leadership and administration of the Consortium, with substantial interaction and input from the Co- Investigators, Scientific Advisory Board, Biomarkers Advisory Group, Training Directors, Patient Advocacy Organizations and Data Management Coordinating Center (DMCC). Both Dr. Lee and Dr. Martin will participate in all in-person network meetings representing the Consortium. An independent Data Safety and Monitoring Board will be established to oversee the clinical trials. Dr. Barry Storer will serve as the Program biostatistician, and Dr. Paul Martin will be the Translational Liaison. Interactions with the General Clinical Research Centers (GCRC)/Clinical and Translational Science Awards (CTSA) units and the DMCC will be at multiple levels of the Consortium as required to accomplish the scientific goals. Communication is critical to the success of the Consortium. Monthly conference calls, supported by a pre-circulated agenda and post-call minutes and action items, will provide structure, oversight and frequent collaborative opportunities. This method of communication has proven to be an extremely efficient and effective collaborative tool. The monthly minutes are circulated to all participating investigators, trainees, DMCC staff, NIH program officers, and advisory groups. Annual reports of the Consortium components will be reviewed by the Scientific Advisory Board and NIH/Office of Rare Diseases. During the third year of funding, a half-day, in-person review will be conducted to evaluate the past progress and future direction of the Consortium.
The purpose of the Administrative Unit is to coordinate the Immune Mediated Disorders after Allogeneic HCT Research Consortium to ensure its scientific and programmatic success. Dr. Stephanie Lee and Dr. Paul Martin will be responsible for ensuring productive communication between all components of the Consortium, including the sites, advisors (scientific, biomarkers and patient advocacy) and the DMCC.
