In addition to the clinical centers/study sites, the trial is implemented through a Clinical Coordinating Center (CCC) at Cleveland Clinic; a Data Coordinating Center (DCC) at RTI International; and various collaborators providing specific expertise as described below and depicted in Figure 3
Figure 3. Organizational Structure of the Pomalidomide for the Treatment of Bleeding in Hereditary Hemorrhagic Telangiectasia Study
The National Heart, Lung, and Blood Institute (NHLBI) will serve as study sponsor. The Steering Committee will consist of NHLBI representatives, and a subset of site investigators who provided input to the design of the study as part of the NHLBI U34 Planning Grant. This leadership team will be responsible for all major scientific and operational decisions. Other trial committees will report to the Steering Committee at regular monthly meetings held by teleconference (or in person if necessary).