Three companies under the Roche umbrella are looking to shake up the way clinical trials are conducted and better understand the patient journey during these studies.

To this end, Flatiron Health, Foundation Medicine, and Genentech have launched the Prospective Clinico-Genomic (PCG) feasibility study. The trial will pilot the use of a technology-enabled prospective data collection platform to facilitate, streamline, and simplify the execution of clinical trials for patients living with advanced lung cancer.

About 1,000 patients will be enrolled in PCG, which has a secondary aim to better understand how genomic changes in a patient’s tumor might predict response or impact resistance to treatment in people diagnosed with metastatic non-small cell lung cancer or extensive-stage small cell lung cancer by a linked data- and bio-repository.

“Doing something in the space of prospective clinical studies is something that Flatiron has been thinking about for a long time,” Dr. Bobby Green, CMO, Flatiron, told MD+DI on Monday. “I think the partnership has worked well because we’re all sort of bringing different areas of expertise to the table.”

Flatiron specializes in data collection and participates in the oncology-specific electronic health records-market. The New York-based company was acquired by Roche in a transaction valued at $1.9 billion in 2018. In that same year, Roche also acquired Foundation Medicine, a company that develops genomic profiling assays to pair cancer patients with relevant treatments and clinical trials, for $2.4 billion.

Roche acquired pharmaceutical company Genentech, nearly a decade ago for nearly $47 billion.

“Flatiron brings its data collection abilities to the table,” Green said. “Foundation Medicine is a leader in comprehensive genomic profiling and liquid biopsy. Genentech is a leader in knowing how to execute clinical trials and in the science of trying to understand how genomic markers in cancer might help us better understand progression or response to certain types of cancer.”

Green added, “All three companies are very aligned around this concept that the way we do clinical trials today is substandard. It’s not efficient; it’s too slow; we don’t accrue enough patients, and it’s too difficult for sites to execute. I think all of us were motivated to do this feasibility study with an eye toward – can we build a platform that ultimately doesn’t just work for this trial but works for many trials like this.”

"Using new platforms to accelerate the development and delivery of the best possible medicines for every type of patient is central to our vision for personalized healthcare," said Mark Lee, global head of personalized healthcare, product development, at Genentech, in a release. "The PCG Study represents an important step toward the next iteration of the clinical research ecosystem, opening up opportunities to extend clinical trials into the real world setting to more investigators and more patients than ever before."

COVID-19 is causing many to rethink the way clinical trials are being conducted. The National Institutes of Health is a prime example. The federal agency has embraced an approach called the adaptive clinical trial to sort through potential drug-therapies for COVID-19, according to a report from the Los Angeles Times. Adaptive designs can make clinical trials more flexible by utilizing results accumulating in the trial to modify the trial’s course in accordance with pre-specified rules.

“I think ultimately one of COVID’s impacts on the clinical trial space … is that it’s accelerated a push to make certain things easier,” Green said.