BU CTSI Supports Early-Career-Stage Investigator Collaboration that Leads to National Multi-Site Study
There is a common catch-22 in research, particularly when examining new, novel pathways and nascent discoveries. Data are needed to support exploratory research hypotheses when submitting proposals for external funding, but funding is typically needed to collect data for testing preliminary hypotheses. Pilot grants funded by the BU Clinical and Translational Science Institute (CTSI) offer a solution to this dilemma by providing support for new exploratory projects where there are few or no earlier studies to which to refer and the focus is on gaining insights and familiarity for later investigation.
Early-career stage investigators Allan Walkey, MD, MSc, assistant professor of Medicine (Pulmonary, Allergy, and Critical Care) and director of Pulmonary and Critical Care Education, and Suresh Agarwal, MD, former associate professor of Surgery (Trauma Surgery) at BUSM received a pilot grant from the BU CTSI in 2010 to explore a new type of treatment for acute lung injuries and acute respiratory distress syndrome. These problems affect more than 200,000 people in the U.S. annually and lead to death in close to 40 percent of the cases. Those who survive are prone to a number of long-term effects including decreased quality of life, decreased levels of functioning, and permanent complications.
Their research focused on an alternative method of mechanical ventilation called Airway Pressure Release Ventilation (APRV). “APRV has theoretical properties that may either reduce or increase additional injury to the lungs that is caused by the ventilator,” Dr. Walkey explains. “Ventilator-induced lung injury is a major contributor to morbidity and mortality in patients with the Acute Respiratory Distress Syndrome (ARDS). Many physicians currently use APRV routinely in caring for patients with the ARDS; however there is little data about other benefits in attenuating ventilator-induced lung injury. This study addresses the large knowledge gaps surrounding the commonly utilized technology APRV.” In addition to researching treatment for ARDS, their research goals include examining ways to prevent ARDS which could save both lives and money.
Barriers to participation in the study, including patients lacking a legally authorized representative (LAR) or consent denied by a LAR, or patients meeting clinical exclusion criteria, resulted in a small sample size—three out of 21 eligible participants were recruited into the study. Despite the number of participants recruited, the research supported by the pilot grant provided preliminary data on experimental treatment, creation of a database, and identification of barriers for participation. The pilot grant also legitimized the study to other research institutions and potential funders. Upon completion of the study, the investigators found the mortality rate of ARDS to be closer to 30 percent rather than 40 percent.
With their preliminary data and experience, the investigators secured a one-year, $1.5M grant from the National Trauma Institute for a multi-center trial with seven other institutions to continue this research. In a follow-up interview, the researchers expressed the importance and timing of CTSI pilot funding in catalyzing their research. For Dr. Walkey, a 2009 graduate of the Clinical Research Training Program (CREST K30) supported by the CTSI and an early-career stage investigator, the pilot funding provided a means for advancing his research career toward externally funded independent investigations. Strengthening the pipeline of investigators is a major focus of the CTSI’s mission.