NCI Accreditation 101

The National Cancer Institute (NCI) Cancer Centers Program, which is responsible accrediting high performance cancer centers, is a leading voice in the nation’s cancer research effort. There are currently sixty-nine NCI-Designated Cancer Centers that form the nexus of the NCI’s initiatives for studying and combatting cancer.  While there are many cancer centers in existence, becoming NCI-accredited is one of the most rigorous and prestigious designations in the country.

History of the NCI Cancer Centers Program

In the early 20th century, cancer was considered a mysterious and pervasive disease. Great minds became attracted to the prospect of conquering the unknown, and with new technology available to them, a handful of laboratories grew to become a network of universities, hospitals and institutions. Physicians and scientists from overarching interdisciplinary projects began collaborating to drive innovation in cancer research.

In 1930, Congress passed the Ransdell Act that created the National Institutes of Health (NIH). This legislation marked a change in attitude of the scientific community toward public funding of medical research. Just five years later, the NCI was created as a part of the NIH with full support from every senator in Congress. This unanimous front against cancer revealed growing concern over the invasive disease. Shortly thereafter, a number of governmental grants started a snowball effect in the cancer research community, producing a number of discoveries and treatments.

The NCI’s role has evolved from authorizing grants for research to encompassing all aspects of cancer awareness and treatment. The NCI has also cultivated an environment in which top-tier cancer research institutions can be recognized, supported and funded. In 1967, eight cancer centers were the first to receive research support from the NCI. Soon after, the NCI established the notion for accreditation based on the criteria set forth by the National Cancer Advisory Board. Over time this evolved into a set of guidelines and requirements that the NCI uses to accredit designated cancer centers today.

NCI Accreditation Today

NCI cancer centers are most often affiliated with university medical centers, though some are stand-alone institutions. NCI-Designated Cancer Centers all focus on some combination of laboratory research (cells or animals), population science (large groups of people) and clinical research (testing treatments on volunteers or patients).

Currently, there are three designations recognized by the NCI:

  • Basic Laboratory Cancer Centers conduct only laboratory research and do not provide patient treatment.
  • Cancer Centers are recognized for their scientific leadership, resources, and the depth and breadth of their research in basic, clinical and/or population science.
  • Comprehensive Cancer Centers hold the most rigorous designation. These centers demonstrate an added depth and breadth of research, as well as substantial transdisciplinary research that bridges these scientific areas. Institutions must pass a thorough review to receive this designation.

Achieving NCI Accreditation

In order to achieve NCI-designation, a cancer center must prove itself capable of making significant strides against cancer, as well as act as a hub of ground-breaking treatments and care for the community. Though there isn’t a specific set of standards that an institution must follow, the review process for achieving the designation is regarded as extremely rigorous.

Although NCI-Designated Cancer Centers have greater responsibility to serve their surrounding communities, the benefits are also significant. According to the NCI, funding “supports shared research resources, provides developmental funds to advance scientific goals, and fosters cancer programs that draw investigators from different disciplines together.” Further, for the select few able to attain the NCI designation, the revenue implications are substantial—millions of dollars in funding for research infrastructure allows these institutions to attract patients and top investigators.

Conclusion

Above all, the NCI Cancer Centers Program serves as one of the anchors in the nation’s cancer research effort. With the help of NCI grants, hundreds of research studies are underway at any given time, from basic laboratory research to assessments of revolutionary cancer therapies. The rapid pace at which NCI-Designated Cancer Centers are discovering new treatments has translated into improved cancer diagnosis and treatments across the world.

References:

https://www.cancer.gov/news-events/cancer-currents-blog/2015/new-cancer-centers

https://www.cancer.gov/research/nci-role/cancer-centers/history

https://www.cancer.gov/research/nci-role/cancer-centers

https://www.advisory.com/international/research/clinical-operations-board/studies/2002/cancer-revenue-strategy/special-report-centers-of-excellence/nci-designated-cancer-centers

Budgeting for Clinical Trials 101

Developing an internal budget can be a complex process, but it’s important for many reasons. First, the internal budget allows the research office to see the actual cost to conduct a study. Additionally, the internal budget is often more detailed than the budget provided by the sponsor. Your internal budget might vary from other institutions due to specific processes, and it can be built in an excel document or directly into a CTMS. Developing an internal budget allows for additional comments and clarifications that may not be possible to add to the sponsor’s template. Lastly, an internal budget can be formatted to meet any specific internal needs. A good example of this might be including specific formulas to account for how much money should be allocated to the PI, the nurse or coordinator, or to cover various departmental fees.

Subject Injury Language: What You Need to Know

One of the negative aspects of clinical trials is the possibility that a patient will suffer an injury or illness as a result of their study participation. As such, one of the most important pieces of a contract is the subject injury language. ‘Subject Injury’ is defined as an injury, illness, adverse event/reaction, or death caused by a study subject’s involvement in a clinical research study. Prior to the study, the research site and the study sponsor should come to an agreement on what exactly constitutes a Subject Injury, and who pays in the event of a Subject Injury.

Four Common Oversights of Investigator Initiated Trials

Within the past two years, investigator initiated trials (IITs) have seen a remarkable renewed interest. While research offices are doing their best to support these endeavors, the additional administrative responsibilities involved are often unfamiliar to research offices. Consequently, mistakes made during the initial development and start-up stages can cause compliance and financial ramifications. Here are four common mistakes to look out for when conducting an IIT study:

HIPAA: Reflecting on the Past and Preparing for the Future

When the Health Insurance Portability and Accountability Act (HIPAA) went into effect over 10 years ago, it was met with great apprehension and concern from those in the healthcare industry. Today, it is one of the most important legal and ethical guidelines in the industry. How has HIPAA evolved since its inception? Let’s step back to examine a few key points in its development.

NCDs and LCDs 101

National and Local Coverage Determinations (NCDs and LCDs) are two of the most important aspects of Medicare coverage. Both NCDs and LCDs are released by Centers for Medicare and Medicaid Services (CMS) to standardize Medicare coverage for certain medical tests and procedures. These determinations outline the conditions in which a service is considered to be covered by Medicare.

Are Small, Independent Research Sites Going the Way of the Dinosaur?

Much has been written about the changing clinical research landscape, and more importantly, the implications these changes are having on small, independent research sites. The first major change was the implementation of preferred site programs by many larger contract research organizations (CROs). The second, and more recent development, is the actual acquisition of research sites and site networks by CROs. Separate of both of these trends, is the premise that “big data” will give larger health systems a competitive advantage, allowing them to reestablish their dominance in Phase II and III research. Each of these themes are explored in greater detail below.

6 Things to Consider When Performing a Coverage Analysis

Developing a coverage analysis (CA) can be a very tricky task, especially for a novice analyst. Nonetheless, it is crucial to conduct CAs in order to ensure billing compliance. There are several important items that need to be considered while building a CA. This list is not meant to focus on every single one of these items, but to highlight a few important items that should be considered while building a CA.