NCRA’s “Mountains of Change” Part III: Biomarkers | Blog

Biomarkers

NCRA’s “Mountains of Change” Part III: Biomarkers

Thu, Aug 29, 2019  -  Comments (0)  -   Posted by Karen Mordarski

NCRA’s 2019 Educational Conference in Denver, Colorado, was built around the theme, “Navigating the Mountains of Change.” And during the four days of sessions I attended, three “mountains” stood out for me as particular challenges for CTRs to navigate:

Precision Medicine & Genetics | Artificial Intelligence | Biomarkers

In previous months, I posted on precision medicine and genetics, as well as artificial intelligence. Today, I will share my notes from an NCRA session on the third mountain, biomarkers, and its role in precision medicine. Jocelyn Hoopes, MLIS, CTR Director of Clinical Abstraction and Mary Visceglia, BSN, RN, OCN, MMCi, Oncology Nurse Consultant presented “Abstracting in the Era of Precision Medicine” which went in-depth on the topic of precision medicine, AI, biomarkers and the cancer registry. Here’s what I took away from their presentation…

WHAT DO BIOMARKERS MEAN FOR OUR PROFESSION?

The CTR profession will take another leap forward with the development of new software platforms capturing “targeted abstracting” of more complex Site Specific Data Items (SSDIs) and biomarker reporting. SSDIs are part of proteomic profiling, identifying usable mutations, or “biomarkers,” and matching treatment to these biologic malformations. In December 2016, Congress passed the 21st Century Cures Act that states,

“FDA shall establish a program to evaluate the potential use of real world evidence (RWE) to support the approval of new indication for a drug approved under section 505(c) and satisfy post-approval study requirements. Real world evidence means data regarding the usage, potential benefits or risks, of a drug derived from sources other than traditional clinical trials.”

So, with precision medicine, we will need standardized guidelines for data capture to fulfill the following:

  • Define Level Setting (for standard of care and treatment and reliability of information (Evidence based standards of care such as National Comprehensive Cancer Network (NCCN) or American Society of Clinical Oncology (ASCO)
  • Timely Maintenance of Update Information

There is good reason to use NCCN Guidelines to drive precision medicine data collection. NCCN is universally used, has known reliability, ease to use, cost efficient, and a single point of contact for disease guidelines, compendium products, and patient resources. The biggest challenges for conventional CTRs who want to adapt to this new targeted abstracting, is understanding anti-cancer agents, treatment lines, genetic / biomarker variations, and testing methodology. These challenges all require more extensive training and education to overcome.

BETTER DATA SAVES LIVES™

As CTRs, we know, better data saves lives™, and biomarkers have the potential to drastically improve the data we collect. That’s a wrap on my blog post series. I hope you’ve enjoyed my notes on NCRA’s “Mountains of Change” and have found my key takeaways useful.

Did you attend this year’s NCRA educational conference? What were your key takeaways?

Interested in learning how CHAMPS Oncology can help your cancer program navigate recent industry changes? Contact us.


Posted in Cancer Registry

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