For the reported time period, MACRO enrolled 1260 (1161 observational, 99 interventional) subjects in 17 active studies (7 observational, 10 interventional) by 22 PIs (and ~50 Co-Is) from 6 Departments/Divisions (MACRO parent Departments, GI Division, Infectious Disease [VA], and Pulmonary, Allergy, and Critical Care Medicine (MICU) in 5 hospitals (UPMC Presbyterian, Montefiore, Shadyside, Mercy, and the VA – Oakland campus).
MACRO also assisted two studies (EM – ACRIN; CCM – observational sepsis studies) in screening and enrolling nearly 100 subjects. For these studies, at the investigators’ request, MACRO provided partial service – specifically, identification and referral of potential subjects, and coverage and/or consent when the investigators nor their usual coordinator were available.
Normalized to a 12 month period for comparison, overall subjects enrolled increased from an average of 57 per month in 2009 to 70 patients per month.
For 5 multi-center studies (average # of sites per study: 16), MACRO in terms of total enrollment, was a top 3 enroller. For two multicenter interventional trials and one observational study, MACRO was the top enroller.
CCM and Surgery investigators comprise half of MACRO clients. Notably, although we primarily assist investigators from our three parent Departments, 26% are from other Departments/Divisions, including for the first time, a PACCM (Pulmonary, Allergy and Critical Care Medicine) Faculty member.
We did not perform formal client satisfaction surveys. Below are examples of client feedback to us.
(n = 27; some studies are based in >1 Department, chart includes post-enrollment completion studies)
Again, although most studies are conducted by our parent Departments, over 1/3 are from other Departments/Divisions, principally the Department of Medicine.
Although MACRO does not currently provide “full-service” Coordinating Center services, at investigators’ request, we have assumed many such duties. Mary Stefanick has been named the lead coordinator for Dr. Nina Singh’s multicenter infectious disease study, and Tina Vita is the lead coordinator for Dr. Stephen O’Keefe’s multicenter SNAP study. Their duties as lead coordinators include training sites on protocol and procedures, helping to develop CRF’s and source documents, answering protocol questions and problems from sites, receiving and organizing monitoring reports, adverse event monitoring, reporting to the DSMB and sponsor, dispensing and tracking investigational product, tracking patient enrollment, and coordinating and participating in Coordinator and Steering Committee conference calls.
In addition to expansion to UPMC Mercy, we also established relations with the UPMC MICU, and have launched a NIH funded study there led by a MICU faculty physician. We have also had discussions with several anesthesiologists for potential research collaboration.