MAKING MEDICAL HISTORY
THE PATH TO PATIENT USE Th ough 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 fi rst tested under controlled conditions in the lab. “When it comes to complex human beings, there are a lot of di ff erent 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 Th omas Buchholz, MD, C hief S cienti fi c Offi cer and medical director, Scripps Cancer Center, and radiation oncologist, Scripps Clinic. For new drugs, scientists may then move on to test for both the e ff ectiveness of the treatment and e ff ects on other organs in the body. Th e drug also undergoes a rigorous
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. Th e “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 arti fi cial knees had to estimate force on the knee joint using force plates, cameras and computer modeling. Th eir calculations could vary greatly. “Knee replacements were failing a little more o ft en than we were comfortable with,” says
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. Clinical trials happen in phases. In Phase I, researchers test their new discovery in humans for the fi rst time. Researchers adjust dosages and watch for side e ff ects in a very small cohort of patients. In Phase II, the study is expanded to a larger patient population and researchers study safety and e ff ectiveness. 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 di ff erent 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 e ff ective,” says Dr. Buchholz. “It’s very important for an institution like Scripps to be involved in clinical trials.” 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 speci fi c patient population that’s eligible for an upcoming trial. Your physician may be initiating the trial or may be part of the investigative team. To learn more, visit Scripps.org/SDClinicalTrials.
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.” Th e 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. Th ey later took them on a hike at Torrey Pines State Natural Reserve and let them play sports like golf and doubles tennis. Th e 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. Th ey were then recognized with an award from Th e 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 e ffi cient 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. An X-ray of the first electronic knee implant developed to measure force on the knee joint to design more efficient and longer-lasting prostheses.
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