Just in Time Clinical Trials: A Solution for Both Academia and Community Oncology

Many of the presentations at the 2022 Oncology Clinical Pathways Congress dealt with the lack of diversity in clinical trials. In his presentation, “Just in Time Clinical Trials—A Solution for Both Academia and Community Oncology,” Ira Klein, MD, MBA, FACP, VPMA, Payer Relations, Tempus Labs, explained how to make it easier to engage and involve these overlooked subpopulations. Starting the final session of the conference, “Session 7: Clinical Trials Optimization in Pathways,” Dr Klein built upon what had been discussed earlier in the congress.

“We’ve just spent the last two-and-half days talking about how we don’t include people who should be included as part of America in clinical trials,” he said. “We instead have included our younger, Whiter, wealthier cohort of America, and left out our more economically disadvantaged, Black and Brown populations who may not live in large urban centers and know to access NCI facilities for their cancer care.”

His talk focused on “how to bring clinical trials to all of America by making it easy for community oncologists as well as academic centers to participate in a more standard manner.”

To start, access is a primary barrier to obtaining a representative population in clinical research.

“If the trials only happen in certain centers in certain parts of the country, they’re not going to be accessible to someone who lives 150 miles outside of Topeka in a rural community,” Dr Klein said. Additionally, community oncologists are very busy, and participating in clinical trials is not always financially beneficial to them.

Another concern is that clinical trials do not represent the proper ethnic, racial, and sociodemographic mix. The US government knows that this is a problem, and it created Cancer Moonshot to try to improve engagement and diversity in clinical trials.

In the adult community, participation rates are between 2.5% to 3.5% in clinical trials. That number increases if pediatrics in oncology is added to the mix, but it still falls short of the desired 10-plus percent. Cancer Moonshot has invested $1.8 billion, providing 7 years of new funding, with the intention of new clinical trial networks to be representative of America and address those inequities among race, gender, and resources.

“Learning from all patients will give us a more accurate and precise understanding of drug therapy for each individual patient using their genomic specifics, not just the genomic specifics of a population that we fixed for the past,” Dr Klein said.

To accomplish this, Dr Klein explained that pathways need to be viewed in a slightly different manner. “Pathways is really about taking industrial engineering concepts in cancer care,” he said. “We’re really talking about clinical workflow and operational processes. Many of the speakers [at 2022 OCPC] were talking about getting a lot of information, communicating amongst each other, implementing evidence-based practices in that plan-do-check cycle. That is what happened in industrial America.”

However, there are several core capabilities needed to empower researchers, including next-generation sequencing, clinical data, pathology, analytic tools, and translational science. These provide data, testing capabilities, and patient trial matching.

“The key is standardization, but does that mean everybody gets the same widget? No,” Dr Klein said. “Take an example from the auto industry, the Toyota factory floor process control. We have a standard production line, but if somebody raises their hand and says, ‘I need to tweak it,’ we’ll tweak it.

“If you can have that communication in real time, you can get trial activation in less than 10 business days as opposed to an industry standard of about 6 months.”

EMR integration is key to making it happen, Dr Klein said. EMR data must be screened for each genomic marker, and then the patients must be screened against the requirements of the available trials. Once a match is found, mechanisms for engagement put out the trial enrollment to the patient and their caring physician. The TIME Trial Sermonix ELAINE 2 study proved that this works.

The benefits, if more trials like Sermonix ELAINE 2 prove to be successful, include increased access to clinical trials for patients in the community; changing the research model for treating physicians, nurses, and research staff; and providing the framework at community sites to support more clinical research. In short, it creates a larger ecosystem for all patients.

“And [by] ‘all of the patients,’ we really mean that we serve communities that strongly resemble the bigger population in this country that would benefit from these diverse initiatives,” Dr Klein said.