History and Rationale for InFACT
Investigator-led multicenter clinical research initiatives have assumed an increasingly important role in acute care research. They have also achieved successes that are disproportionate to their size and financial resources. For example, while 29 of 87 phase III/IV ICU clinical trials registered with ClinicalTrials.gov in the winter of 2009 were industry-funded and sponsored, of 38 ICU-based clinical trials published in the New England Journal of Medicine since 1995, 34 were initiated and led by independent academic investigators.
Active investigator-led clinical research groups exist in North America, Europe, and Australia and New Zealand; fledgling initiatives are emerging in South Africa, South America, Asia, and the Middle East. These groups ask similar questions, and face similar challenges. Questions relevant to the care of critically ill patients are often best answered through international studies that can evaluate geographic differences in disease epidemiology, capture the impact of regional patterns of practice variability, and recruit large numbers of patients in a timely manner. And international collaboration by academic investigators also brings the possibility of greater influence over the methodologic rigor and conduct of research conducted by industry. Thus it is timely and appropriate that we increase collaboration amongst academic investigators to overcome the barriers to research involving critically ill patients, to enhance the scientific rigor and expedite the conduct of multicenter clinical trials, to engage the public, global health bodies, and regulatory agencies, and ultimately, to improve the clinical care provided to critically ill patients around the world.
A meeting of clinical researchers who are actively involved in investigator-led clinical trials groups was held in Granada Spain, in association with the Sepsis 2008 meeting of the International Sepsis Forum (ISF). The ISF provided logistical and financial support for the meeting which was called InFACT (International Forum for Acute Care Trialists). Subsequent discussions in Nashville in February 2009 at the annual meeting of the Society of Critical Care Medicine, and in Brussels in March 2009 at the International Symposium on Intensive Care and Emergency Medicine enabled the participation of members of additional investigator-led groups, and refined the vision and mission statement, and terms of reference. Through these initial get discussions, we agreed to develop formal terms of reference to develop InFACT as a network of investigator-led acute care research networks. A Steering Committee will direct ongoing discussions to develop a constitution and bylaws that will be submitted for approval to the participating networks. Their adoption will result in the formal launch of InFACT.