These Philly Doctors Are Helping More Patients Receive Breakthrough Lung Disease Treatments—and Advancing Care Across the Country

When patients are looking for options in the face of sudden, severe illness, the latest treatments are often their main source of hope. Even for individuals who have struggled with lung disease for years, the idea that a treatment may one day become available to help improve their condition provides a critical thread of optimism to hold on to.
The thing is, sometimes those treatments are already available. It’s just a matter of making patients and physicians aware of them.

“Clinical trials are one of the best ways to access the latest treatment options,” says Dr. Rachel N. Criner, pulmonologist at the Temple Lung Center in Philadelphia. “Clinical trials offer treatments that have been through extensive testing for safety and efficacy but are not yet a standard form of treatment. At the end of the day, we aim to make sure patients know all of their options.”

At the Temple Lung Center, an international leader in lung disease research and care, a dedicated team of physician-researchers are at the forefront of groundbreaking advancements in pulmonary health–and have been for decades. Clinical trials require a significant amount of coordination and investment, but the Lung Center has made it a priority to offer breakthrough options to patients from all backgrounds.

“We are a leading center nationally and probably globally for COPD,” Criner says. “We attract patients not just from the Philadelphia region, but across the mid-Atlantic region—and then we have people who come from all over the country and some internationally.”

To maximize the impact of enrollment in clinical trials, in the past year, Dr. Criner has established a program to expand patient access to trials. The research program proactively engages and educates patients about clinical trials they may be eligible for, making sure they don’t miss an opportunity for potentially life-changing treatment options and feel empowered to make the decisions they are most comfortable with for their care.

The process is an extension of the central promise of advanced health care—access to groundbreaking treatments for everyone. At the same time, with a larger patient population of greater diversity, the clinical trials and research program have enhanced the Temple Lung Center’s ability to develop better treatments for more patients. As a result, this proactive approach to clinical-trial recruitment presents a scalable solution that could inspire other medical centers to expand their own research efforts and help more patients in need.

Getting Patients the Right Help

Despite the fundamental role clinical trials play in providing and developing new treatments, they’re not always universally accessible, and the right trial doesn’t always come to the patient who needs it most. Many different trials are starting and ending every day with different, specific qualifications, so many patients and even physicians are unaware of all the trials that may offer an improved quality of life.

“Traditionally, if you’re a patient who doesn’t have the means or doesn’t always remember to call your doctor about that obscure research trial they mentioned—you would not get enrolled,” Criner says. “At the same time, providers might not be aware of the full set of clinical trials … We were seeing that the process to enroll in a trial was hard to navigate and wanted to support patients and providers by making trials more accessible.”

That’s why Dr. Criner led the creation of a recruitment system. Every pulmonologist at Temple Health is kept up to date on the trials being conducted through both regular meetings and internal advertising, such as clinic flyers and newsletter emails. But to make sure every patient has an opportunity to enroll, Temple’s team of physician-researchers reviews patient charts and identifies potential studies. If a patient is a match for one or more trials, they will receive a phone call about study details and enrollment support.

“We have a very streamlined approach now where we don’t lose any patients. Everything is tracked within an electronic system, and we call them within about two business days,” Criner says. “If they’re eligible for five trials, we let them decide.”

As a result, the Temple Lung Center has become the top recruiter for several national studies, and by operating multiple trial sites in Greater Philadelphia, they’ve been able to serve patients across Pennsylvania and beyond. Perhaps most importantly, the system improves access to the trials for people from all backgrounds.
“We have a huge, diverse population,” Criner notes. “And it helps enhance diversity in our trials.”

Better Care–Even with the Placebo

While access to the latest therapies is important for patients, the benefits of clinical trials on patient participants have an impact far beyond them. For one thing, clinical trials offer closer monitoring in addition to standard care. This is especially critical in diseases that can advance rapidly between routine check-ins, a common phenomenon in the kind of lung diseases the Temple Lung Center treats.

“We might be seeing you every four weeks to eight weeks in a trial, so compare that to being seen every three to six months in standard practice,” Criner says. “One patient saw us only for a research study–he was being managed locally otherwise. But on one of his study visits, I realized he needed a lung transplant. He just got listed last week.”

It’s important to understand that the care received in a trial does not have added risks or downsides. Those worried about getting a placebo can rest assured that no one in a trial is denied standard care.

“None of these studies stop standard of care,” Criner explains.

What’s more, most of the trials Temple Health runs are in later phases. That means the medications being delivered have already shown promising results in smaller populations, and they are now being tested in a broader group for final confirmation.

“And for Phase Three trials, if the medication works, it is often provided to patients even after the trial, before FDA approval,” she says. “So even if you got the placebo during the trial, you may still end up getting the medication.”

Standard-Setting Treatments

Of course, access to breakthrough treatment is still the key benefit of participating in trials, and at the most advanced centers, you may be receiving treatment that will change what’s thought possible in regards to a particular disease.

“For conditions like COPD, clinical trials at the Temple Lung Center led to breakthrough treatment, and that has really changed the standard of care,” Criner says. “And there are other serious lung conditions for which we’re testing new medications right now that I expect to change the standard of care in the near future … Clinical trials are really how those standards are established.”

One of the most significant examples of these kinds of exciting innovations is bronchoscopic lung volume reduction, or BLVR, a procedure that improves breathing and quality of life in COPD patients without invasive surgical interventions.

“We were the leading center for that study,” Criner says. “We brought our trial data to the FDA … and that’s now standard of care for COPD patients.”

Today, the Temple Lung Center is pushing nonsurgical innovations further with a surprising degree of creativity and ingenuity. One study is testing a specialized foam sealant that can restore fissures—splits in lung tissue that otherwise disqualify patients from receiving valves that restore quality of life through BLVR.

Temple is also taking advantage of growing insights into the nature of lung disease to create a systematic approach to research. They’re now enrolling patients in trials for new inhalers and treatments aimed at specific subtypes of COPD.

“We’re now moving toward understanding there are different phenotypes of COPD patients,” Criner says. “Those who are more inflammatory might benefit from biologic therapies. And another type might not. It’s not a one-size-fits-all approach anymore.”

One of their priority areas of research targets patients with interstitial lung disease, or ILD. There’s currently no cure for ILD, and average survival is a matter of years, even after a lung transplant. Temple Health has taken the lead in changing that, enrolling the highest number of patients in a recent study evaluating a new medication that aims to slow down progression of the disease faster than other medications.

“We were the leading recruiter in the United States for both the IPF group and the PPF group [for those trials],” Criner says. “And the drug company has already released that the study drug worked and helped further slow down disease. It’s honestly revolutionary.”

Altogether, the trials that the Lung Center runs have rapidly expanded in recent years and are now broad and varied, from oral medications to infusions to inhalers.

While Temple Health’s program offers a model for other centers, Criner stresses that all patients should know they have options—no matter where they’re being treated.

“No one should ever be told there are no treatment options for their disease–there are plenty of treatment options that can be explored. I always tell patients, you have to advocate for yourself,” Criner says. “It’s a matter of always looking for the best treatment possible, even when you’re not sure what that looks like yet. And that’s the foundation of what we do here.”