In 2002, the Department of Critical Care Medicine began a Clinical Trials Program (CTP) to coordinate all industry-sponsored trials within the Department. In 2005, under Dr. Scott Gunn as Director and Ms. Barbara Early as clinical research coordinator (CRC) Director, the CTP streamlined screening and enrollment of ICU patients and employed three CRCs for five studies.
From 2002–07, the CTP expanded and due to overlapping patient populations, increasingly coordinated with a similar program in the Department of Surgery. In 2008, the two Departments decided to join forces under a single entity called MACRO (Multidisciplinary Acute Care Research Organization) to maximize collaboration, productivity, and efficiency. In 2009, the Department of Emergency Medicine also joined.
Together, the three Departments jointly run MACRO as an internal clinical research organization with a focus on acute care research. A key service MACRO offers investigators is 24/7 screening and enrollment. In calendar year 2009, this level of service enabled enrollment of 129 patients in interventional trials and over 800 patients in observational trials.
Our Mission is to facilitate clinical research led by dedicated investigators in an ethical, regulatory compliant, and fiscally sound manner.
MACRO executes this mission by serving as a highly engaged and essential “co-investigator,” with ultimate direction and responsibility for each study resting with their Principal Investigators (PI). MACRO seeks to highly assist and fully inform PIs with subject screening and enrollment, protocol execution, budget, and regulation compliance duties, and thus allow PIs to focus on science, patient care, and other duties. MACRO also seeks to assist new investigators and trainees interested in clinical research, and to bridge not only Departments but also the three core missions of academic medicine (Education, Patient Care, and Research).
MACRO is led by an Executive Committee (Director and Co-Director, physician faculty from each Department, and the CRC Director) and overseen by a Steering Committee (Chairs of each Department). As of July 2011, MACRO employs 8 CRCs, a 0.5 FTE financial manager, three full-time support staff, on-call laboratory personnel, and multiple University of Pittsburgh college students who serve as Research Associate interns.
Philosophically, MACRO endorses a quote by Dr. Lawrence W. Green: “If we want more evidence-based practice, we need more practice-based evidence.” In our view, it should not be strange or rare for a patient to be in a clinical study. Rather, we should ask, “Why isn’t this patient in a study?" – particularly because the most promising bench work and animal studies require validation in human trials in order to improve patient care.
Internally, MACRO as an organization endorses a “More Work and Responsibility = More Reward and Satisfaction” philosophy and strives to create a challenging, collegial, fair, and productive work environment where all ideas are welcome, and each person’s talent, skills and energy are maximally deployed and developed for both individual and organizational good.