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On the first day of the Community Oncology Alliance (COA) Annual Meeting (April 23, 2020), Howard “Skip” Burris, III, MD, FACP, FASCO, president and chief medical officer, Sarah Cannon Research Institute, and current American Society of Clinical Oncology (ASCO) president, discussed a successful clinical trial research program setup between Sarah Cannon Research Institute, Florida Cancer Specialists, and Tennessee Oncology.
Dr Burris began his presentation by listing the challenges of clinical research, including a vast number of trials, rare mutations, education, expansion cohorts, patient access, eligibility criteria, trial complexity, overwhelming paperwork, and data volume and interpretation. A consistent theme throughout the presentation was the importance of “taking clinical trials to the patients and community practices, rather than hosting them at tertiary cancer centers.”
The Genospace platform for genetically profiling patients was highlighted as an exemplary accomplishment of the research program. Dr Burris explained that profiling patients is important for the patient and individual benefit, for clinical research and drug development, and for cancer research and the larger benefit of all. The Genospace platform is designed to enable the convergence of clinical research and clinical care; large-scale clinical-genomic data aggregation leading to discovery and trial recruitment; and clinical decision support.
“For community practices, being able to profile our patients, aggregate that data, and understand whether you have that population is going to be critical to interaction with pharma biotech on whether you’re a great site for participating in a clinical trial,” he asserted.
Dr Burris then dove into examples of overcoming challenges of expansion cohorts and patient access, the first of which was a spotlight of the types of trials in the PRiMER program. The impetus behind PRiMER was observations of early-phase studies growing larger, with expansion cohorts that replace the traditional “phase II study”; many of the expansion cohorts enrolling rare tumor types, or patients with minimally and sometimes untreated disease; and multi-histology studies becoming increasingly common. The objectives of the PRiMER program are to allow more patients and physicians access to clinical trials by bringing earlier phase research and novel trials designs to traditional “late phase” clinics, as well as to contribute to accelerated drug development by opening large expansion cohorts in the clinics where patients are being seen.
As for challenges of eligibility criteria, Dr Burris highlighted a study led by R Donald Harvey, PharmD, BCOP, FCCP, FHOPA, Winship Cancer Institute of Emory University (Atlanta, GA), titled, “Impact of Broadening Clinical Trial Eligibility Criteria for Advanced Non-Small Cell Lung Cancer Patients: Real-World Analysis.” The trial showed that by using ASCO and Friends of Cancer Research broadened eligibility criteria for clinical trials, researchers enabled more patients to participate, make trial population more representative and results more generalizable, and accelerate patient accrual.
To overcome challenges of trial complexity, overwhelming paperwork, and data, Dr Burris recommended investment in site management organization, including clinical trial pipeline, regulatory, safety, contracting and budget services, site development and management, central IRBs, quality assurance, IT capabilities and support, and marketing support.
Additionally, the research program invested heavily in systems to aid in execution of increasingly complex trials. One such investment has been in e-consent, which has been a “huge satisfier for many of our patients who are in outreach or rural sites where we might have a physician who is visiting once a week to provide care.” He continued: “This enables the patients to go through some initial screening and consent processes without having to make the trip into the city or having to visit multiple offices only to find out they’re ineligible or not in a situation where they can participate in a clinical trial.”
In his concluding remarks, Dr Burris referenced the clinical research space after COVID-19. The pandemic is likely to forever change biopharma, he stated, leading to a greater focus on vaccines and prevention, increased adoption of artificial intelligence, smart automation (eg, remote or virtual work), virtual and digital clinical trials, and regulatory flexibility.—Zachary Bessette
