How Clinical Trials Transform Medicine

Scripps doing share with 90 ongoing trials, past breakthroughs

Darryl D’Lima, MD, PhD, director, Orthopaedic Research Laboratories, SCORE, Scripps Clinic. SD Health Magazine

Darryl D’Lima, MD, PhD, director, Orthopaedic Research Laboratories, Shiley Center for Orthopaedic Research and Education (SCORE), Scripps Clinic

Scripps doing share with 90 ongoing trials, past breakthroughs

There’s a common misconception that research happens separately from medicine. At Scripps, research is a critical part of the mission to provide the best care to patients. Many promising new treatments begin in clinical trials. The knowledge gained from these clinical studies helps advance the quality of care for people in San Diego and beyond. 

“Every single treatment, drug intervention and care item we deliver to our patients started with research,” says Addie Fortmann, PhD, Chief Research Officer at Scripps.

“When we go to the hospital, emergency room, primary care physician or a specialist visit, the care provided wouldn’t be delivered if it didn’t start with research. Research is really the foundation for medicine.”

What is a clinical trial?

What is a clinical trial?

A clinical trial is a research study in which patients volunteer to help researchers test a new treatment, drug, procedure or technology. An investigator or company brings forward a new idea and compares its effectiveness to that of existing treatments.

This research approach leads to incremental advances in the standard of care and, ultimately, better outcomes for patients. Each step is with the perspective of the physician, patient and community in mind. Clinical trials also give patients access to therapies that may yield better results for them than more widely known treatments. 

Currently, around 90 clinical trials are underway at Scripps in such fields as cancer care, cardiology and orthopedics.

“The biggest impetus for clinical trials is when we have a disease or a condition that is not responding in all cases to our available traditional treatments. That’s when we know there’s a gap, and we need to fill that with science and innovation,” says Dr. Fortmann. “When we have clinical trials at Scripps Health, we give that patient one more option.”

Knee replacement breakthrough at Scripps

Clinical trials can also focus on collecting patient data. For instance, Scripps made medical history with its development of a smart electronic knee implant for patients who needed knee replacements. 

The “e-knee” measured the distribution of forces on the implant from such activities as walking, exercising and climbing stairs, then transmitted that data to computers at Scripps Clinic’s Shiley Center for Orthopaedic Research and Education (SCORE) in real time via tranducers, a microtransmitter and an antenna. Not bad for the late ’90s and early 2000s, before Wi-Fi was widely available. 

Previously, designers of artificial knees had to estimate force on the knee joint using force plates, cameras and computer modeling. Their calculations could vary greatly.

“Knee replacements were failing a little more often than we were comfortable with,” says Darryl D’Lima, MD, PhD, director, Orthopaedic Research Laboratories, SCORE, Scripps Clinic. “We found that knee design was still stuck in the old way of designing components. It was a painful, laborious process, and most of the complications were related to excessive force.” 

The team also rethought their methods of collecting data. At the start of the study, they were observing a small number of patients in a controlled setting as they performed everyday tasks like walking, exercising or getting out of a chair. They later took them on a hike at Torrey Pines State Natural Reserve and let them play sports like golf and doubles tennis. The researchers found that some movements, like a golf swing or even an accidental stumble, exerted much more force on one or both knees than originally thought. 

Dr. D’Lima notes that the team was having a hard time getting their research published — until pro golfer, Tiger Woods, sustained a stress fracture and strain to his leading knee. They were then recognized with an award from The Knee Society, a prestigious membership organization for thought-leaders in knee arthroplasty. 

Results of the groundbreaking Scripps study gave scientists and engineers working on knee replacement the ability to design more efficient and longer-lasting prostheses. It also helped establish what activities would be safe, moderately safe or risky for patients who have undergone a knee replacement surgery. 

Testing for safety and effectiveness

Though the medications, devices or procedures being tested in a clinical trial are new, patients can rest assured that there’s a lot that goes on before it can be used on humans. 

When researchers make a new discovery, it’s first tested under controlled conditions in the lab. 

“When it comes to complex human beings, there are a lot of different factors that can determine the outcome of a particular treatment. But in the laboratory, you’re able to isolate the mechanism of action of a particular new treatment, study it and show that it works,” says Thomas Buchholz, MD, chief scientific officer and medical director at Scripps Cancer Center, and a radiation oncologist at Scripps Clinic. 

For new drugs, scientists may then move on to test for both the effectiveness of the treatment and effects on other organs in the body. The drug also undergoes a rigorous safety study to gauge potential toxicity. If everything checks out, researchers go to the Federal Drug Administration and apply for an investigational new drug license, which allows them to begin clinical trials. 

Stages of clinical trials

Stages of clinical trials

“Medicine continues to advance all the time, and it’s exciting. And it does predominantly through clinical trials."

Thomas Buchholz, MD

Clinical trials happen in phases. In Phase I, researchers test their new discovery in humans for the first time. Researchers adjust dosages and watch for side effects in a very small cohort of patients. In Phase II, the study is expanded to a larger patient population and researchers study safety and effectiveness. For Phase III, the cohort is expanded even further. Some participants are given the new treatment and others, the standard treatment or a placebo. Dr. Buchholz notes that medical devices have a different pathway for FDA approval. 

“Medicine continues to advance all the time, and it’s exciting. And it does predominantly through clinical trials. Whenever there’s a new drug introduced for any type of disease, it has gone through a series of clinical studies to prove that it’s effective,” says Dr. Buchholz. “It’s very important for an institution like Scripps to be involved in clinical trials.” 

Who can participate in a clinical trial?

If you’d like to learn more about clinical trials at Scripps, your primary care physician or specialist is a good place to start. Or your doctor may notify you if you’re part of a specific patient population that’s eligible for an upcoming trial. Your physician may be initiating the trial or may be part of the investigative team. 

San Diego Health Magazine cover, spring 2024

This content appeared in San Diego Health, a publication in partnership between Scripps and San Diego Magazine that celebrates the healthy spirit of San Diego.

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