Policy on COI Review for ASTRO Formal Papers

1. Introduction

The American Society for Radiation Oncology (ASTRO) is committed to the highest ethical standards when developing trustworthy formal papers (including Clinical Practice Guidelines, Consensus Statements and White Papers), as set forth in the National Academy of Medicine’s “Standards for Developing Trustworthy Clinical Practice Guidelines” and the Council for Medical Specialty Society’s “Code for Interactions with Companies” and “Principles for the Development of Specialty Society Guidelines.” ASTRO’s formal papers (Formal Paper(s) or Paper(s)) are documents that represent ASTRO’s formal position and are intended to be published in a public venue. These documents are considered core to ASTRO’s mission. ASTRO accepts no funding for development, nor involvement of any industry employees* in the development process. ASTRO recognizes that task forces must include a range of experts, who in some cases have relevant disclosures, and that the inclusion of these experts can strengthen the writing effort and confidence in the quality and integrity of the published document when those disclosures are transparent and conflicts, including perceived conflicts, are properly managed to address COI concerns.

As ASTRO’s guideline development process[1] has matured over time, safeguards have been incorporated into the process which include the clear delineation of key questions to be addressed by the guideline, formal consensus of authors, robust COI review and management, expert peer review and public comment. The ASTRO guideline methodology and disclosure management policy are designed to further foster confidence that the development process for ASTRO Formal Papers is free of bias or improper influence.

2.  Task Force Disclosure Requirements for Relevant Relationships and Affected Company Definition

ASTRO requires all prospective task force members to complete a disclosure statement at the time of nomination and report all health care-related relationships (both compensated and uncompensated), regardless of the perceived relevance to the topic of the Paper for transparency purposes. Disclosing these relationships does not necessarily imply a conflict of interest (COI). The reporting timeframe is for 2 years prior to nomination.

The policy requires disclosure of employment, leadership positions, speaker’s bureau, consulting, advisory roles, honoraria, stock, ownership, royalties, patents, research funding (both personal and institutional), travel expenses, gifts or other in-kind compensation received by the task force member and/or immediate family members.

To assure a broad array of perspectives, the task force is selected to include academic and community practice clinicians and members who hold varying intellectual positions on the topic. An effort is also made to have broad representation in terms of race, ethnicity, gender, and geographic location.

In order to review disclosures, it is necessary to determine which relationships are relevant to the topic and could create a potential COI. Relationships with companies that may be affected by the paper constitute the greatest potential source for COI. An affected company is defined as any company developing, producing, marketing, selling, or distributing health care goods or services where there is a reasonable likelihood of direct regulatory or commercial impact (positive or negative) on the company (or its product/service) as a result of recommendations made in the Paper.

Companies that produce equipment and systems that are intrinsic to the basic practice of radiation oncology (linear accelerators, information systems, etc.) will be considered affected if recommendations could significantly impact utilization of, or acquisition of, equipment or systems produced by that company. Such companies will be considered affected for a given Paper (deemed an “Affected Company”) if one of the following criteria is met:

1. If the Paper addresses a patient cohort that represents more than 3-5% of total U.S. radiation oncology patient population (e.g., broad cohorts of breast, prostate, lung, and head and neck  cancers, or treatment of metastatic disease) and if the Paper may address one of the following:
   1. significantly different fractionation regimens
   2. treatments of varying complexity
   3. a significant expansion or contraction of the indications for standard radiation techniques.
2. If the Paper will address the application of a new or emerging technology that could broadly change the complexity of radiation oncology treatments, render obsolete, require purchase of new equipment or software systems or retrofitting of standard equipment, or confer a competitive advantage to the company.

3.  Formation of the Task Force (Disclosure Policy and Process)

ASTRO requires that a majority of task force members be free of relationships with affected companies. Specifically, at least 51% of the total number of participants, including the chairs, must have no financial relationships with affected companies or other relevant disclosures; relationships with non-affected companies are disregarded.  Disclosures that are current or ended during the 1 year prior to initiating the document must be reported and are evaluated according to ASTRO’s policy as detailed in section 5 below. Task force members who have relationships with affected companies that would prevent participation must terminate those relationships prior to the start of the guideline process (this excludes the chair who must be free of relationships with affected companies for 1 year prior[2]). Institutional research relationships with an affected company do not count as a financial relationship with an affected company unless the personal research criteria apply.

An individual is not eligible to serve on a task force if they:

• Participate in a speaker’s bureau, advisory board, or appear in marketing, promotional or endorsement materials for an affected company.
• Serve in any capacity as a Radiation Oncology Benefit Manager (ROBM) or have a relationship with any type of utilization review company evaluating radiation oncology services.
• Are employed by an affected company at any time during the 1 year prior to nomination.
• Hold an ownership/equity interest, defined as owning shares of a publicly traded company or an equity interest in a privately held company that is either >5% of shares or >$10,000 in value, at the time of disclosure, in an affected company.
• Hold a relationship with an affected company or any other interest that, in ASTRO’s discretion, presents a risk of actual or perceived bias that cannot be effectively managed or could undermine public confidence in the paper.

Additional Chair/Vice-Chair Requirements: The chair is an expert selected primarily to manage the task force. The chair has final decision-making authority. In addition to task force participation requirements, the chair must comply with the following:

• The task force chair must be free of all financial interests in and relationships with affected companies for 1 year prior to appointment to this position, must agree to remain free of these interests and relationships throughout the task force’s work and for 1 year after the guideline is ASTRO Board approved. The purpose of this requirement is to provide a sufficient time period before initiating the task force to maintain public confidence in the impartiality of the chair.
• The task force chairmay not have personal research funding from an affected company. However, a chair may serve on an independent data safety monitoring board for a trial sponsored by an affected company.
  • The task force chair may not have institutional research relationships with an affected company if they have fiscal authority and/or direct decision-making responsibility.

The vice-chair refers to an individual who serves in conjunction with a chair but is subordinate to that chair. In general, ASTRO prefers to have a vice-chair without any relationships with affected companies; however, if the expertise or standing in the field of a candidate vice-chair would add importantly to the quality and credibility of the guideline without raising serious concern about conflict of interest, the vice-chair may be permitted to have research or limited consulting relationships  with an affected company, as defined in the Table below. The following requirements also apply to the chair and/or vice-chair:

• The task force chair and vice-chair may not participate on a speaker’s bureau or advisory board as defined by ASTRO for an affected company for 1 year prior to appointment to this position through 1 year after the paper is Board approved.
• The task force chair and vice-chair may not engage in representing or allowing their name to be used by an affected company on marketing materials or in any way that could appear to promote or endorse an affected company or its products.
• The task force chair and vice-chair must refrain from giving industry-sponsored talks on the guideline for 1 year post-publication and should publicly disclaim that they "are not an official spokesperson for the ASTRO guideline task force" if speaking about material related to the guideline content.

4.  Disclosure Categories

The following definitions describe the categories of relationships used for reporting disclosures. ASTRO recognizes that organizations use different names for some activities, particularly “speakers’ bureau” and “advisory board.” ASTRO uses the following definitions and expects individuals to apply these definitions to their relationships and report under the category as ASTRO defines it, rather than by the name industry uses.

5.  Task Force Member Selection Process

• First, the full Guideline Subcommittee (GLSC) identifies potential types or categories of affected companies that may be impacted by the guideline, as defined above, as an initial step to facilitate selection of the task force chairs.
• Prospective chairs are evaluated by the GLSC leadership and then the Clinical Affairs and Quality Council (CAQC).
• ASTRO’s Conflict of Interest Review Committee (COIRC) will independently review the proposed list of affected company categories and chair/vice-chair disclosures before selections are finalized. If consensus is not achieved between CAQC and COIRC, a call between the leadership of each oversight committee would be held.
• Once confirmed, the task force chairs refine the scope of the document, including drafting key questions. This refinement will further inform the types or categories of affected companies. If changes are made, such changes should be re-reviewed by COIRC.
• Next, the GLSC, proposed task force chairs, and staff compile a list of prospective task force members.
• ASTRO staff reviews the Centers for Medicare & Medicaid Services (CMS) Open Payments database and prior ASTRO disclosures (if previously submitted) for any disclosures related to the proposed task force members.
• Based on preliminary review of this information, ASTRO staff sends preliminary invitations to nominees requesting they complete a full disclosure statement.
• The task force chairs, GLSC leadership and ASTRO staff review prospective task force members’ disclosures against the affected company list to identify any potential COIs and ensure that the task force remains below 50% of members in relationships with Affected Companies. Additional information regarding individual disclosures may be requested to fully evaluate the relationships.
• If there is any controversy or uncertainty about a member’s disclosure or potential COI, or a failure of the CAQC leadership to approve the task force, the COIRC will convene to provide guidance regarding participation.

6.  Managing Disclosures and COI

Once the disclosures have been reviewed and approved, it is the responsibility of the task force chairs and ASTRO staff to manage disclosures and potential COI appropriately. Task force members are encouraged to avoid new relationships during the document development process, but those that do arise must be reported to ASTRO staff immediately and their disclosure statement updated promptly.  If new disclosures could adversely impact the composition of the task force, the individual may be asked to withdraw from participation.

Additionally, if subsequent changes in the marketplace, document scope, or in other circumstances suggest that additional companies may be impacted by the paper, the task force chairs must report this to ASTRO staff who shall obtain review from the CAQC and COIRC of any new affected company determinations and potential COIs.

Management Process:

• The task force chair reads the ASTRO COI disclosure statement at the beginning of each conference call or meeting.
• ASTRO staff then displays the table of disclosures, requesting that all task force members review/confirm their disclosures, report any changes, and update their disclosure statement promptly, as needed.
• If new disclosures are reported, they are reviewed by the task force chairs,  ASTRO staff (and GLSC chairs, if necessary). COIRC will review new disclosures related to the task force chair(s) or vice-chair(s). Where necessary,  appropriate action is taken, including but not limited to, modifying writing assignments.
• Members with a relevant disclosure are dispersed among the key questions to avoid any perceived bias or influence and will not be assigned primary writing roles.
• If a task force member appears to be unduly influencing the outcome of a discussion, regardless of disclosures or other potential biases, the member may be asked to leave the conference call for the discussion at the discretion of the chair.
• For transparency to the public, all (comprehensive) health care-related disclosures are published with the guideline.
• If a situation occurs where the vice-chair has an approved relevant relationship and the chair has to step down from the guideline, a new chair who meets the chair COI requirements will be selected.  

7.  Peer Reviewers

Reviewers should comprise a full spectrum of relevant stakeholders (experts, organizations, agencies, patients, and representatives of the public).

Reviewers must disclose all relationships. Given the role of the reviewer in the ASTRO paper development process, it is generally acceptable for reviewers to have relevant disclosures. In fact, they may have been selected because of their unique perspectives and secondary interests. Reviews from such individuals or organizations may be helpful in anticipating and dealing with controversy, improving the clarity of the final document, and promoting engagement with all stakeholders/constituencies. There are no disclosure restrictions for participation in a document’s external peer review process, except if the reviewer is employed by or receives salary from a health care company.

All disclosures are shared with the task force for review while responding to the reviewer’s individual comments to acknowledge any potential biases. In addition, ASTRO staff review, and flag for the task force chairs, comments submitted specifically from reviewers who have a speaker’s bureau relationship or ongoing advisory role with an affected company to ensure that their comments are considered in that context to avoid any bias. The peer reviewer disclosure table is published in an appendix to the document.

8.  Appendix: Background

In June 2015, the ASTRO Board approved a Policy on Conflict of Interest Review for ASTRO Formal Papers. In January 2016, an additional guidance document was approved by the Board which included more detail on implementing the COI policy.

In September 2017, an addendum to the COI policy was approved describing ASTRO’s policy on relationships with radiation oncology benefit managers (ROBMs) or utilization review committees.

In June 2019, another addendum to the COI policy was approved which focused on defining an advisory board relationship.