NCCN Guidelines® & Clinical Resources
NCCN Guidelines® and Derivative Information Products: User Guide
Transparency of the NCCN Guidelines, the NCCN Compendium, and the NCCN Templates Development
Over the past decade, the NCCN Guidelines and their associated information products such as the NCCN Compendium and NCCN Templates have become influential in determining the standard of care in oncology in the United States and around the world. With this responsibility, NCCN has become increasingly aware that there is significant interest in both the processes by which the NCCN Guidelines and derivative materials are developed and the potential biases of developers. In fact, the Centers for Medicare and Medicaid Services adopted new requirements as of January 1, 2010 for continued approval of oncology compendia.
NCCN supports the call for increased transparency and has proposed a number of process changes to enhance the user community’s understanding of NCCN processes. NCCN will add several new features in the coming year to further this goal.
Beginning with NCCN Guidelines developed or updated in calendar year 2010, NCCN will provide increased transparency in the following areas:
Panel participation in NCCN Guidelines update processes and voting
- Updating the NCCN Guidelines and NCCN Compendium each year is a multi-step process. Attendance records for panel members participating in each activity leading to an NCCN Guidelines update will be posted on NCCN.org. These activities include: participation in one or more meetings or teleconferences, review of proposed changes in the NCCN Guidelines, authorship of the discussion, etc.
- Votes of panels on new interventions and indications will be published with each new recommendation for a drug or biologic. These votes will be published in the minutes of the panel meetings/calls on NCCN.org.
Evidence for changes in recommendations
- Institutional review and development of call/meeting agenda: Staff has developed a new format for institutional reviews asking that the request for change be supported by one or more citations. Similarly the format for external submissions will include the specific request and supporting data. The panels will be provided the results of the institutional reviews and any outside submissions of data using the new format.
- Listing of requests: Comments from NCCN Member Institutions will be grouped as NCCN Member Institution comments without identification of a specific institution. Outside submissions will be listed according to the type of individual or organization making the request, e.g., advocacy group, industry, payor, individual clinician, etc. Each request will be listed with the portion of the NCCN Guidelines which it addresses, a summary of the change requested, and citations that support the change.
- External submissions: Requests for inclusion of interventions in the NCCN Guidelines and NCCN Compendium are received from organizations and individuals outside the NCCN membership. A long-standing policy requires that each submission include a cover letter outlining the desired change and evidence supporting the change. Typically this evidence consists of one or more peer-reviewed publications; however, in some cases abstracts from medical meetings or unpublished data are submitted. The new policy will require that any submission to NCCN be published on NCCN.org. NCCN will notify individuals or organizations submitting material to the panels that their submissions will become public record.
- Publication of results of deliberations: Minutes of panel deliberations will be published on NCCN.org. For each change request, a summary of the discussion of the data will be published along with the specific citation(s) supporting the request and the vote. Both positive and negative panel determinations will be published. Votes will be reported as members for, members against, and members abstaining.
- Evaluation of Evidence: Each recommendation in the NCCN Guidelines is evaluated by the NCCN Guidelines panel members and the strength of the evidence is identified using the NCCN Categories of Evidence and Consensus. The panels consider the body of evidence that is available for each recommendation in the NCCN Guidelines. The goal is to base each recommendation on high-quality evidence from controlled clinical trials or meta-analyses. However, because the NCCN Guidelines address the continuum of care from diagnosis (or in some cases even prevention and screening) through palliative care, there are many situations where high quality evidence simply does not exist. In some cases this is because randomized studies have not been done on the value of routine diagnostic or staging tests. In other cases, studies of combination therapies, sequencing of treatments, or head-to-head trials of effective therapies do not exist. In these situations, the NCCN Guidelines panels use lower level evidence that may include non-randomized trials; case series; or when other data are lacking, the clinical experience of expert physicians.
It also should be noted that oncology is a heterogeneous discipline with very different quantities and quality of data across disease sites. In a disease like breast cancer, there are thousands of publications that can be considered and many large trials comparing different treatment strategies, modalities, combinations, and sequences of treatment. In less studied diseases or those with few patients, there may be very few reliable trials with the literature consisting largely of case studies. In these disease sites recommendations are based on existing published literature, extrapolation of data from similar clinical situations, and the clinical experience of physicians who treat relatively large numbers of patients.
NCCN Categories of Evidence and Consensus
Panel members identify the level of evidence supporting each recommendation. These categories are:
- Category 1: Based upon high-level evidence, there is uniform NCCN consensus that the intervention is appropriate.
- Category 2A: Based upon lower-level evidence, there is uniform NCCN consensus that the intervention is appropriate.
- Category 2B: Based upon lower-level evidence, there is NCCN consensus that the intervention is appropriate.
- Category 3: Based upon any level of evidence, there is major NCCN disagreement that the intervention is appropriate.
All recommendations are category 2A unless otherwise noted.
In addition to publication of the results of deliberations described above, evidence considered by panels in making their recommendations historically has been and will continue to be published in the discussion section of the NCCN Guidelines. This discussion provides a review of the data considered by the panel in the context of overall disease management. Interpretation of the data considered and relative merits of interventions as evaluated by the panel members are discussed to provide richer understanding of the recommendations by users. NCCN will continue its policy of citing only data that provide useful guidance to treating clinicians rather than formal systematic reviews. This policy ensures that appropriate information is readily available to support clinical decisions. In cases where data have been considered and found unpersuasive, the panel may or may not choose to review the data in the discussion.
Availability of Archival Information
- Requests for changes in the NCCN Guidelines from organizations and individuals outside the NCCN will remain available online for three years and be available upon request for two additional years.
- Evidence considered and key points discussed in the analysis of the data will be available online for three years and be available upon request for two additional years.
- Votes on requests for changes in the NCCN Guidelines will be available online for three years and be available upon request for two additional years.
Disclosure of Potential Conflicts of Interest
- NCCN publishes individual disclosures of potential conflicts of interest for panel members, NCCN Guidelines staff, and NCCN senior management. Relationships disclosed include research funding, participation in advisory groups, participation in speakers’ bureaus, employment, and equity or patent ownership.
- Beginning in 2010, the NCCN Board of Directors has directed that panel members compensation from external sources be less than published thresholds. These thresholds are ≤ $20,000 from a single entity and ≤ $50,000 in aggregate from any source. The NCCN Board, NCCN Guidelines steering committee, panel chairs, and panel members have been notified of this new policy.
- Currently, disclosures pertain to panel members and staff with respect to employment, equity, royalty disclosures, clinical research funding, participation in speakers’ bureaus, advisory committees or consultancy disclosures.
- An archive of five years of disclosure information will be maintained on NCCN.org.
NCCN Guidelines Infrastructure
NCCN Guidelines Steering Committee
The NCCN Guidelines Steering Committee supervises the NCCN Guidelines program and reports directly to the NCCN Board of Directors. Each NCCN Member Institution has a representative on this committee who is responsible for coordinating the NCCN Guidelines activities at his or her center. The responsibilities of the NCCN Guidelines Steering Committee include:
- Selection of topics for Guidelines Development: NCCN Guidelines topics are based on prevalence of disease, relevance of the area to oncology practice, need for NCCN Guidelines, and availability of appropriate NCCN expertise.
- The NCCN Guidelines Steering Committee also approves selection of panel chairs.
- Promulgation of NCCN Guidelines development policies: Although each panel determines the specific recommendations of a pathway, the NCCN Guidelines Steering Committee is responsible for developing policies to ensure consistency across disease sites.
- Coordination of NCCN Guidelines activities within NCCN Member Institutions: The NCCN Guidelines Steering Committee members are responsible for naming the institutional representative to the NCCN Guidelines panel, overseeing the institutional review process (see below), and coordinating implementation activities.
NCCN Guidelines Panels
A panel of experts with members from each of the NCCN Member Institutions develops the NCCN Guidelines. Currently, 44 panels meet at least annually. The NCCN Guidelines Panel Members are chosen by the panel chair and the chair of the NCCN Guidelines Steering Committee from a list of institutional nominees. In some instances when special expertise exists, several representatives from an individual NCCN Member Institution may be included. In several NCCN Guidelines Panels (e.g., myelodysplastic syndromes, distress management), outside consultants have joined NCCN Panel Members to contribute their unique expertise when it is needed.
Specialties that must be included on a particular panel are identified before that panel is convened but also evolve as the standard of care changes over time. Surgical oncology, radiation oncology, medical oncology, and important specialties, such as gynecological oncology, neuro-oncology, and gastroenterology, are included as indicated. This multidisciplinary representation varies from panel to panel (e.g., the Bone Cancer Panel required a physiatrist, the CNS Panel required a neuropathologist). The participation of oncology nurse practitioners, social workers, and other health professionals was essential to develop recommendations for symptom management and supportive care pathways. Many of the panels also include a patient representative, especially when issues of long-term care and patient preference are paramount in the panel's considerations.
The inclusion of different management philosophies is equally important. All major strategies of disease management must be considered so that the NCCN Guidelines will be acceptable to the broad NCCN membership. The NCCN Guidelines Panel Chairs are charged with ensuring that representatives of all treatment strategies are included. This often leads to protracted and even intense panel discussions, but the process has been designed to foster dialogue and full discussion of available data and evidence.