Trial by Fire: How to Action N-of-1 Clinical Trials for Cancer Patients

No two cancers are the same, and the focus is rapidly shifting away from treating cancers based on body-site location to treatment based on the molecular profile of the tumor. Advances in precision oncology have generated greater understanding of the unique cellular mutations that are driving each person’s unique cancer and what interventions can be used to target these drivers (e.g. immunotherapy drugs).

Clinical trials have been the classic research approach to determine if a new cancer treatment improves patients’ outcomes.  Typically, this type of research means recruiting hundreds and even thousands of patients with the same site-based cancer diagnosis and stage of disease and splitting them randomly into groups.  One group receives the new therapy and the other group receives usual standard of care (SOC) treatment. In 2006, there were 35,743 active clinical trials and in 2018, there are currently more than 250,000 trials registered with ClinicalTrials.gov.  Matching and recruiting to and monitoring patients during these trials is hugely time consuming and problematic.  Couple these tasks with the resource challenges to recruit patients, manage treatment, report adverse events, and store, manage, and interpret these data, it is little wonder that most community oncologists have not enrolled their patients on trials and why treatment advances take longer to be approved and used than all stakeholders would like.

Moreover, in this new era of precision oncology, the uniqueness of each cancer’s tumor profile is rendering the classic clinical trials research method obsolete. First, we can’t easily find and enroll 1,000s of patients with all the same genomic drivers (as cancers often have more than one driver), split them into two patient groups and then conduct a comparison of a novel treatment.  Today, in precision medicine, because each patient’s cancer has a unique molecular profile, the patient becomes her or his own trial. The solution, therefore, is to treat each patient’s cancer based on its unique drivers with the novel interventions or agents believed to target these drivers as an “N-of-1” trial.

The availability of and correct interpretation of next-generation sequencing results gives the physician the information she or he needs to help the patient be an N-of-1 trial. Decision-support tools make this decision possible at point-of-care; the physician can easily be made aware of the drivers, the potential targeted therapies and have the tools to apply, monitor and manage the patient throughout her or his treatment. These can then be compared to results the intervention achieves in other patients who have the same genomic driver regardless of what site the cancer is first reported in (e.g. if the same gene is driving lung cancer and colon cancer in different patients does the drug work in both?)

Matching, notification, treatment management and data collection becomes a much simpler and manageable problem for an AI platform that “thinks” like a doctor and applies sound logic and medical management rules.  VieCure’s platform was built to address this need, literally in seconds, when the physician requires it.

The N-of-1 method will become the new standard in medicine given the precision needed to properly address the results we now have available to us related to the genomic make up of an individual’s cancer.  It will make matching, recruiting, enrolling and managing the treatment and data collection faster and more effective for cancer providers, and more importantly, cancer patients will receive the right treatment, matched to their personal situation, when they need it, to ensure success.

--

About VieCure (VieCure and related products are the property of Viviphi Ltd)

We codify the world’s premier cancer guidance from clinical research centers around the world into a technology platform that considers each patient’s unique needs and supports the care team, patient and their family through diagnosis, treatment and follow-up.

VieCure is headquartered in Greenwood Village, Colorado. For more information, visit www.viecure.com.

Contact:
Michael G. Power
Chief Business Development Officer
michael.power@viecure.com

Factorial Complexity in Cancer Care is Here and Overwhelms!

Factorial Complexity in Cancer Care is Here and Overwhelms!

Genomics-based research is advancing at a pace that it is difficult for any cancer practitioner to interpret, absorb and action. The growing list of biomarker-driven care options compounds the already complex list of factors required for efficient and effective decisions to be made at point of care. Research in cancer care is at an all-time fever pitch. The Scopus database shows more than 1 million peer-reviewed publications and scientific proceedings on the topic of cancer research since 2008. How can any single physician or practice stay current, sift through and select from this vast library, and ultimately make safe sense of it for her/his patients?

VieCure Welcomes New Chief Technology Officer

VieCure Welcomes New Chief Technology Officer

Steven Malme will Lead Engineering, Research & Development for the VieCure Precision Medical Platform VieCure has named Steven Malme as its new Chief Technology Officer. Malme will lead VieCure’s engineering, research & development team and drive continued enhancements to the VieCure world-leading oncology platform. Malme comes to VieCure from Microsoft where he led Corporate Accounts and Partner Sales in Asia, driving sales performance and an optimal customer experience. He held this same leadership position in EMEA, driving double-digit revenue growth and launching the cloud transformation across Microsoft’s sales team and partner channel. Microsoft offered him the opportunity to work in many senior leadership roles including global responsibility for health care industry sales and Dynamics partners.

Storm Warning: Old Ways Will Fail in Cancer Care

Storm Warning: Old Ways Will Fail in Cancer Care

Streamlining care with AI decision-support tool. By 2026, there will be ~26 million cancer survivors in America, and more than 2.1 million people who will be newly diagnosed with some form of cancer. Alarmingly, by this timeframe, about 25% of oncologists will be retiring and given current and projected enrollments in medical school, the replacement rate of oncologists will be only 13%.

Intelligent Mobile App Keeps Cancer Patients Out of the ER

Intelligent Mobile App Keeps Cancer Patients Out of the ER

Intelligent mobile app will improve communications between cancer patients and providers and reduce ER visits. Nonadherence to treatment plans is estimated to account for as much as 50 percent of treatment failures overall, and even for cancer patients, whose lives are on the line, adherence can be as low as 14 percent. Technology can help head-off these negative outcomes. Cancer patients become overwhelmed. The complexity and volume of daily medications and symptom monitoring, while they are experiencing life-altering emotional and physical changes, is the perfect setup for mistakes, oversights, stress and hopelessness. Intelligent mobile technology can break these daily tasks into bite-size pieces and deliver them at the right time, relieving a patient’s responsibility to constantly monitor all facets of their care. 

CMS decision transformative for cancer care

CMS decision transformative for cancer care

The Centers for Medicare & Medicaid Services’ (CMS) decision to reimburse for Next Generation Sequencing (NGS) for patients with advanced cancer is a major step to realizing personalized cancer treatment. This reimbursement approval fits perfectly with the expanding use of VieCure’s comprehensive platform for precision cancer care that optimally utilizes NGS within its proprietary VCureEyellation™ AI engine.