For Hua Ling, PharmD, research is a vital way to connect clinical trial data with what he sees in his daily practice. That connection, according to Ling, is not always straightforward.
“Sometimes there is a gap between the clinical trial and what we do in our daily practice,” he explained.
In a clinical trial, researchers attempt to determine if new medical treatments, drugs or devices are safe and effective. Participants are carefully selected and the trial is conducted under controlled circumstances. Ling’s research is focused on understanding how the medications studied in a clinical trial actually work in real-world settings and how they impact patient outcomes.
As part of a recent research project, Ling analyzed results from a clinical trial involving a drug therapy for patients with HFrEF (heart failure with reduced ejection fraction). The therapy—a quadruple therapy with ARNI, beta-blockers, MRA, and SGLT2i—has been established as first-line therapy for patients with HFrEF in current heart failure guidelines.
In the trial, the drug therapy was up-titrated over a two-week span from the initial low dose to the target dose.
“The selection criteria of the trials evaluating rapid titration of quadruple therapy potentially restricted the external validity of those trials,” Ling explained. “So we conducted a drug utilization analysis to retrospectively review the medical records of patients with HFrEF at our clinic and assess their eligibility for the clinical trials.”
When Ling compared the characteristics of his patients with those selected to participate in the clinical trial, he discovered that a substantial portion of his patients would have been ineligible for the rapid titration therapy. Because of this, it would not be possible for his patients to reliably see the benefits observed in the clinical trial.
By running comparisons using data from patients’ medical charts, he and his team tried to point out the study limitations, which were not fully addressed by the trial results.
“What we suggest is that perhaps we can be a little bit more conservative,” he said. “Maybe we need a month or even more time. From a safety perspective, do we need two weeks for rapid titration or can we go longer?”
According to Ling, studies of this nature are important.
“In our daily practice, we do not pick our patients,” he explained. “Therefore what you see in the clinical study, you might not see that same outcome in our patients.”
Once they receive a prescription, pharmacists check to see if it is safe for the patient. At a hospital level, pharmacists look for trends that would inform better usage of medications.
“From the pharmacy perspective, we always care about the drug usage,” Ling said. “That is a focus of this profession.”
In his role as an associate professor of pharmacy practice at PCOM School of Pharmacy, Ling is teaching his students to think about ways to improve patient outcomes by reviewing emerging drug therapies.
In his medical writing class, Ling instructs his students to find a topic of interest and search for information about new drug therapies, changes in treatment guidelines or findings about the disease itself. Students must summarize their findings and present them in the format of a mini-review.
Ling said he expects students to tell him what the problem is, describe what they have found and, based on what they have found, explain if current practices should be changed. The question, Ling added, is “Are we going to do new things or do the findings reinforce that what we are doing is correct?”
This exercise is very similar to what Ling does when he retrospectively reviews charts from clinical studies and prepares case reports.
“We raise the questions,” he said when describing how he examines data and attempts to determine if there is more to be learned.
“It's just exciting to find something that has not been reported before, and then we share it with the scientific community,” Ling said. “By conducting drug utilization analysis, we can improve the quality of patient care, enhance therapeutic outcomes, prevent adverse drug reactions, and reduce inappropriate pharmaceutical expenditures, reducing overall healthcare costs.”
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