“I’m going to tell the story of the development of the Division of Brain Injury Outcomes into an academic research organization,” began BIOS director Daniel Hanley, MD, to a virtual audience. “This is more of an anecdotal talk, and for those of you who are disappointed by not having enough data, I apologize.”
Hanley gave a presentation titled “BIOS Over the Years: Developing the Division of Brain Injury Outcomes (BIOS) into an Academic Research Organization” at a Johns Hopkins School of Public Health seminar. The hour-long talk on Sept. 9 was the first in a series hosted by the JHSPH Center for Clinical Trials and Evidence Synthesis during the 2021-2022 academic year.
Hanley shared many lessons learned over the course of his career in clinical research, particularly highlighting the importance of sequential trials. “The results of your prior trial should inform you to do one of two things: undertake the next trial in that area or move to a different area,” he advised. His piece of wisdom for anyone interested in clinical trials: no matter what your hypothesis is, there is always an alternate hypothesis to explore through research.
Despite his initial apology, Hanley shared some key data BIOS produced over more than two decades of research. He also acknowledged Karen Lane, CCRP, and Nichol McBee, MPH, neurology department faculty members he described as “both the brains and the muscle behind [BIOS].”
Through the National Institutes of Health (NIH) STRIDES Initiative, BIOS collaborated with Google Cloud to dramatically improve the speed and precision of interpreting brain hemorrhage volumes from computed tomography scans. Instead of outlining the hemorrhage area on each CT slice by hand and calculating the total volume, BIOS began using an artificial intelligence algorithm to process the de-identified image files. The result: a process that previously took hours or days could be completed in minutes. Additionally, Hanley shared Bland-Altman plots showing that estimates done by hand often strayed from accuracy compared to the more reliable AI-produced results. The improved speed and accuracy allowed BIOS to begin using hemorrhage volume as a biomarker.
In 2016, the NIH’s National Center for Advancing Translational Sciences (NCATS) awarded a seven-year, $25 million grant to BIOS and the Johns Hopkins Institute for Clinical and Translational Research to form, in partnership with Tufts University School of Medicine, the JHU-Tufts Trial Innovation Center. BIOS’ work as a TIC has focused on operational innovation rather than trial design innovation.
One area of focus for the JHU-Tufts TIC has been the trial start-up period, where delays often occur. Lane, the administrative director of research at BIOS, led the efforts to standardize and streamline the start-up process, using site navigators to guide study sites through the maze of trainings, contracts, and approvals. Hanley backed this up with a slide of box-and-whiskers plots showing the average time to site activation for several BIOS trials. The MISTIE III trial, begun before this innovation was implemented, had an average of 240 days until site activation. The first trial conducted through the TIC was TREAT-MS, a multiple sclerosis trial, which saw sites activated at an average of 170 days, Hanley described. He highlighted several BIOS trials that since then have achieved site activation in an average of 90 days or less using Lane’s streamlined process.
Near the end of his talk, Hanley shared one further piece of advice that pointed toward an investigator’s need for both planning and a little humor. “I’ve had this saying over my desk for 35 years,” Hanley said, “You can’t implement without the seven Ps: proper prior planning prevents piss-poor performance.”
The JHSPH Center for Clinical Trials and Evidence Synthesis made a full recording of the presentation available.