Interventional pulmonary group aims to provide and support multicenter prospective trials

Lonny Yarmus, DO, MBA, FCCP
Lonny Yarmus, DO, MBA, FCCP

A consistent gap in academic interventional pulmonary growth has been limitations in high-quality and collaborative research to produce prospective multicentered clinical trials. Lonny Yarmus, DO, MBA, FCCP, and other researchers, sought to change that by spearheading the establishment of the Interventional Pulmonary Outcomes Group (IPOG), which aims to provide and support multicenter prospective trials in the interventional pulmonary space.

Dr. Yarmus, a specialist in interventional pulmonary and clinical director for the division of pulmonary and critical care medicine, at Johns Hopkins, shared the progress IPOG has made by outlining a variety of studies in his CHEST 2020 Pasquale Ciaglia Memorial Lecture in Interventional Medicine “Raising the Bar: Interventional Pulmonary Outcomes Group.” The session is available for viewing on the virtual CHEST 2020 meeting platform through February 1, 2021, for registered attendees.

The mission of IPOG, Dr. Yarmus shared, includes:

  • Improve the survival outcome and equality of life of adults with pulmonary diseases through the conduct of high-quality clinical trials.
  • Evaluate new or existing technologies focused on diagnostic and therapeutic interventions for the lung in the context of clinical research.
  • Develop and conduct practice-changing clinical trials funded through federally funded agencies.
  • Develop and conduct industry-supported clinical trials that are important to IPOG’s research mission.
  • Support young investigators from many disciplines within the IPOG research enterprise through fellowships, travel awards, and IPOG next generation investigator awards.

Before Dr. Yarmus shared information about IPOG, he honored Dr. Ciaglia, a humorous man and tremendous innovator. After watching a colleague perform a percutaneous kidney stone removal procedure with a set of straight serial dilators, which used a Seldinger technique to access the kidney, Dr. Ciaglia realized that the same principle of using sequentially larger dilators could be used for tracheostomy. Dr. Ciaglia then collaborated with Cook Medical to develop the Blue Rhino.

Dr. Ciaglia was constantly innovating, and the interventional pulmonology community continues to honor that legacy by creating novel approaches to provide safe and minimally invasive care, tremendous clinical growth, rapid expansion of training programs and board certification, and societal growth, Dr. Yarmus said.

However, the one consistent gap in interventional pulmonary has been that lack of high-quality and collaborative research.

In 2019, David DiBardino, MD, from Penn Medicine, looked at the current issues. He developed an analysis of the common pitfalls and solutions with studies aimed at diagnosing lung cancer. What was lacking? It was collaborative efforts of prospective multicentered clinical trials. At the time (before IPOG), only a handful of RCTs were within the field, and there were no strict core group of researchers within organizations, no great avenues for clinical researchers to collaborate and obtain funding, and extremely limited NIH/NCI funding history in interventional pulmonology, he said.

“But the answer is a collaborative research group made up of engaged researchers to produce productive multicentered efforts,” Dr. Yarmus said. “And as importantly, provide research mentorship to advocate for junior faculty research support/training and funding success.”

Common pitfalls and solutions with studies aimed at diagnosing lung cancer

Common Study DesignPitfallSolution
Single-arm study with new deviceNo clear comparison arm to judge new device’s efficacyParallel trial design with a control arm
No clear power calculationUnclear if the study can statistically fulfill the aimConsideration of the study goals and preemptive power calculations
Highly selecting patients for novel diagnostic testLack of generalizabilityOffer trial enrollment to consecutive patients being worked up for lung cancer.
Expert centers onlyLack of generalizabilityMulticenter design
Limited demographic and descriptive reporting of biopsy procedureLack of generalizabilityCareful reporting of lung cancer prevalence in the study population and detailed reporting of nodule characteristics
Lack of confirmation for true negative biopsiesCannot calculate sensitivity for lung cancer for a technologyAdequate clinical follow up for all nonmalignant biopsies

DiBardino 2019

One of the first IPOG efforts was a multicenter, prospective randomized trial called the Standard Bronchoscopy With Fluoroscopy vs Thin Bronchoscopy and Radial Endobronchial Ultrasound for Biopsy of Pulmonary Lesions, which showed that bronchoscopy with or without a thin scope and R-EBUS had a poor diagnostic yield for pulmonary lesions. Future work should focus on improvements in technique and advances in technology that ensure a higher likelihood of obtaining a tissue diagnosis, he said, sharing that “this really was the first modern randomized controlled trial in bronchoscopy.”

This led to multiple other projects through IPOG and beyond, including a First-In-Human Use of a Hybrid Real-Time Ultrasound-Guided Fine-Needle Acquisition System for Peripheral Pulmonary Lesions: A Multicenter Pilot Study.

“This technique was to look at a miniature ultrasound probe to see if we can obtain ultrasound images in the periphery as we do with radial ultrasound but combine that with a convex EBUS philosophy and try and have a real-time guided approach to sample needles in the periphery in real-time imaging guidance,” Dr. Yarmus said.

To see more work by IPOG and the interventional pulmonology community, watch Dr. Yarmus’s complete talk on the virtual CHEST 2020 meeting platform.

There are ongoing efforts with large societies, including CHEST and ATS, to collaborate on guidelines, in addition to IPOG Research Conference and an IPOG Junior Investigator Grant.

“We hope this is just the start of the IPOG network and collaborative efforts to advance the field,” he said. “ … Hopefully this pipeline continues, and the international and national collaborations will continue to expand in a very open and free research network.”

Dr. Yarmus emphasized that IPOG is an open network.