Prospective Clinico-Genomic Study

Learn how Flatiron, Foundation Medicine and Genentech developed a novel platform for execution of real-world studies.

The challenge: Burdensome clinical trial design and manual, multi-system processes to execute trials

Traditional clinical trials may have complex trial designs, cumbersome processes and hefty documentation requirements, making it difficult for community practices striving to allocate resources across many initiatives to open new trials and maintain research programs. These operational burdens impact research teams and patients alike, as patients often have to come in for visits scheduled outside of their routine care, and research teams are left with manual, paper-based, multi-system processes to capture and transcribe data.

Stringent trial eligibility criteria and increased screening time also impact trial accessibility, resulting in an extremely low enrollment rate with only eight percent of adult oncology patients on clinical trials¹. These challenges present a unique opportunity to reimagine traditional clinical trials.

The solution: The Prospective Clinico-Genomic Study

Flatiron Health, Foundation Medicine and Genentech partnered to develop a novel, low-interventional prospective study for patients living with advanced lung cancer 一 the Prospective Clinico-Genomic (PCG) study.

The PCG study piloted the use of a technology-enabled prospective data collection platform and aimed to alleviate clinical trial operational challenges.

Less restrictive eligibility criteria that enabled more patients to participate

This study was designed to have less restrictive inclusion/exclusion criteria so any adult patient with a documented diagnosis of metastatic non-small cell lung cancer (NSCLC) or extensive stage small cell lung cancer (SCLC) who was planning to initiate a standard of care systemic anti-cancer treatment was eligible, regardless of line of therapy.

Centralized workflows that lowered operational burden

Participants used OncoTrials®, the clinical trial workflow platform integrated with OncoEMR®, to centrally manage all PCG-related activities. A PCG recruitment list in OncoTrials® surfaced potentially eligible patients to coordinators who could prioritize for review and to physicians at the point of care. Coordinators used OncoTrials® to generate patient study numbers, track patient status on the study, and respond to queries.

Real-world study design that saved time for patients and research teams

The trial was designed to reflect real-world care patterns and build upon data already collected during routine care. The trial design eliminated the need for extra patient visits scheduled outside of routine care. PCG also sought to leverage data already collected during routine care by capturing data directly from the EHR and utilizing technology-assisted abstraction, eliminating the need for case report forms. No separate electronic data capture (EDC) system was needed.

The outcome: Reduced operational burden and streamlined workflows at the point of care to maximize patient enrollment

One practice enrolled over 40% of their eligible patient population and pre-screened almost every eligible patient using OncoTrials®.

The PCG study met recruitment projections with 950 enrollments over 18 months, in spite of COVID-19 related disruptions. One hundred percent of surveyed sites said that they would run a similar study again.

The combination of less restrictive inclusion/exclusion criteria, centralized workflows in OncoTrials® and OncoEMR®, and the study’s real-world design reduced the operational burden required to run the study and helped sites maximize patient enrollment in the trial.

At Clearview Cancer Institute, Dr. Emily Pauli saw the same result. She noted that, “the fact that I didn’t need to assign a data coordinator was huge.” She also found that it took approximately the same amount of time to care for a patient enrolled in PCG and a patient following standard of care treatment.

PCG’s innovative study design resonated with physicians and patients alike. “We’ve had positive feedback from physicians,” Kailee shared. “It’s easy for them to enroll patients, and the liquid biopsy results from the study provide them with helpful information for treatment decisions. Patients have also been very receptive to participating because it’s a low commitment for them. We would love to participate in a similar study like this.”

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