RegenerativeMedicine.net

SPRY Clinical Trial Is First of Its Kind

The trial, called SPRY, will determine whether the antidiabetic drug metformin helps older adults recover from surgery.

Jenny Blair, writer for PittMed, reports in her article that in April 2019, Pitt began enrolling patients in one of the world’s first trials that combines the electronic health record with a new, efficient, safety-focused randomization process. The system is powered by software created by the Texas-based Berry Consultants. The approach, called REMAP (randomized, embedded, multi-factorial, adaptive platform), may transform the way doctors learn from patients—and how they care for them.

In 2015, McGowan Institute for Regenerative Medicineaffiliated faculty member Derek Angus, PhD, MPH (pictured), published in JAMA the article entitled “Fusing Randomized Trials With Big Data: The Key to Self-learning Health Care Systems?” His landmark paper proposed the new REMAP approach to clinical trials.

The trial, called SPRY, will determine whether the antidiabetic drug metformin helps older adults recover from surgery. SPRY is funded by UPMC’s Immune Transplant and Therapy Center. It costs about $5 million, a fraction of what it would cost to run a more conventional trial to answer the same questions. Some takeaways:

  • New participants are likely to be randomized to the better performing arms of the study. Likewise, patients already enrolled who don’t respond well to their assigned experimental treatment may be reassigned to groups that seem to be responding better.
  • The odds of being assigned to the best therapy go up as enrollment proceeds and researchers learn more.
  • The algorithm watches the results throughout.
  • New treatment arms are introduced in response to what’s been learned.
  • Hopefully, in the end, there’s a newly vetted treatment that becomes a standard of care. If not, the platform can test another therapy.
  • The platform can be adjusted for other clinical trials.

Dr. Angus imagines that REMAP-type trials may one day become part of everyday care. Experimental treatments for cancer, sepsis, and other highly complex problems are particularly well-suited to this approach.

“In a way, it would seem intolerable to ever let your bedside clinician with imperfect knowledge try to make a decision under uncertainty when an overarching adaptive platform may have more knowledge about the best odds of treatment than anything else,” Dr. Angus says.

Dr. Angus is Chair of the Department of Critical Care Medicine of both the University of Pittsburgh School of Medicine and the UPMC Healthcare System. At the University, he holds the rank of Distinguished Professor and the Mitchell P. Fink Endowed Chair in Critical Care Medicine with secondary appointments in Medicine, Health Policy and Management, and Clinical and Translational Science and he directs the CRISMA (Clinical Research, Investigation, and Systems Modeling of Acute Illnesses) Center. He also co-directs the UPMC ICU Service Center, responsible for the provision of ICU services across the 20-plus hospital system.

Illustration: McGowan Institute for Regenerative Medicine.

Read more...

PittMed (Fall 2019)

US Clinical Trial: REMAP Trial for Optimizing Surgical Outcomes at UPMC (UPMC REMAP)

Bio: Dr. Derek Angus

Abstract (JAMA, 2015;314(8):767-768.)