Clinical Research Advances Patient Care at Scripps

That research at Scripps can largely be sorted into two categories: clinical trials sponsored by medical device or pharmaceutical companies and conducted by Scripps physicians, and physician-initiated studies led by Scripps clinicians who primarily provide patient care. 

“These clinicians have a passion for expanding and always improving the care they provide their patients,” says Fortmann. “And we help them do that in the most innovative and effective way.” 

When Tim Wang, MD, an orthopedic surgeon at Scripps Clinic Jefferson, learned about the MISHA Knee System clinical trial, he knew it was a promising breakthrough for patients with medial knee osteoarthritis, and wanted to make that option available to Scripps patients. 

This is often the most important consideration when it comes to clinical research. As part of a trial, physicians and surgeons learn and employ the latest techniques and treatment protocols, and Scripps patients gain access to those innovative treatments that would not otherwise be available. 

The MISHA Knee System is a new device that can be implanted on the inner side of the knee during an outpatient surgery. At its core, the device acts as a shock absorber to help unload pressure that would otherwise be put on the knee and joints. It can reduce peak forces on the knee by up to 30 pounds. 

More than 15 million Americans are affected by knee osteoarthritis, and many have tried all the options available for relief. Working with Scripps research services, Dr. Wang was able to learn more about the new implant, the surgical procedure and the trial’s protocols, then was able to begin the trial in just a few months. 

“At one time it might have taken 18 months to get a trial started due to various delays, but we’ve reduced that now to three to six months or even less,” says Chelsea Butler, a director in Scripps Clinical Research Services. 

Of course, the sooner trials can begin the sooner patients can benefit. The Scripps clinical research team is managing close to 120 open clinical trials in multiple specialties, including cardiology, oncology and orthopedics. 

“Whether it’s a new heart valve replacement, a cancer protocol or a knee implant, we want our physicians to have these alternative treatments as soon as possible so they can care for their patients,” says Butler. 

“In clinical research we say that ‘time is life,’” adds Addie Fortmann, “That can be quality of life or a life lived longer.” 

For cancer patients, remission can bring both joy and anxiety. This is something that Ann Kuo, MD, a hematologist and oncologist at Scripps Clinic, has seen firsthand in caring for cancer survivors. For example, patients know that physical activity can reduce the risk of cancer recurrence, but that uncertainty about recurrence can keep them from the activities they need. 

That was the premise Dr. Kuo brought to the Scripps Research and Development team in 2023. Together, they developed AM-WELL, a “multimodal wellness intervention for breast cancer survivors.” 

“This is how physician-initiated research often begins,” says Haley Sandoval, manager of Scripps Research and Development. “Physicians will want to research something specific to their practice, and we help to develop the written protocols and objectives, then operationalize the study within Scripps.” 

AM-WELL participants meet weekly through a structured but social program that promotes a group-based mindset and interpersonal connections, and includes coaching, instruction and physical activity. 

“Patients appreciate being part of this social group,” says Sandoval. “They develop good exercise habits, and some even meet each other outside of the group to continue their health journeys.” 

Often inspired by experiences in their own practice, physician-initiated research can take multiple forms. 

“A good share of our trauma research is retroactive or prospective,” explains Dunya Bayat, Scripps Supervisor of Trauma Research. “In retroactive studies we review the records of former patients for specific data, and in prospective studies we work with patients in real time to discover new data.” 

For patients who have suffered a mild traumatic brain injury (mTBI), getting back to their normal lives as soon as possible is a priority. Existing post-injury research, however, relates mostly to returning to work or specific sports. When it comes to getting behind the wheel, there’s not much to go on. 

Scripps is helping to fill that information gap by studying how driving abilities may change throughout recovery. 

Initiated by Walter Biffl, MD, a trauma surgeon at Scripps Clinic and trauma medical director at Scripps Memorial Hospital La Jolla, the “Driving Performance After mTBI” study looks at how post-injury mTBI patients perform in driving competencies at three different levels of recovery. 

Using a driving simulator at Scripps Encinitas Rehabilitation Center, patients’ reactions are assessed while steering, stopping, multitasking and driving in multiple environments. 

Nearly 2 million people in the U.S. sustain a mild traumatic brain injury every year. Trauma studies like this, now in partnership with Rady Children’s Health, can help adult and teen brain injury patients safely return to their lives after care. 

Nearly all patient care provided today — treatments, surgeries, therapeutics — in some way began with research, which is why they are so integrated at Scripps. 

“There are some who believe that research is something we do on the side at Scripps,” says Fortmann. I would say research is a key part of the exceptional care Scripps provides. 

“The care we deliver is informed and made better by the research our physicians are leading,” Fortmann adds. “It can be as simple as testing an idea to improve care, or as complex as a new treatment option. Research is central to our mission.”