Terms of Reference

Global Quality Assurance of Radiation Therapy Clinical Trials Harmonization Group

Harmonization Group vision

Many national and international clinical trials involving radiotherapy are conducted across several countries and often worldwide. There is a growing demand for collaboration between different groups conducting these trials for the following reasons. Firstly, for some diseases, international cooperation is required for sufficient patient accrual to achieve adequate statistical power. Secondly, broader acceptance of the trial results and thus an increased impact of the trial can be achieved.

As several publications, suggest the appropriate quality assurance of radiotherapy results in strong statistical power of the trial results. Approaches to radiotherapy and radiotherapy QA for multi-institutional clinical trials have been developed independently throughout regions of the world. By harmonizing these approaches, international collaboration of clinical trials involving radiotherapy by various trial groups can be significantly enhanced.

Harmonization Group mission

To promote harmonization of radiotherapy quality assurance between trial groups globally.

Harmonization Group goals and strategy

  1. Bring together, homogenize and distribute information regarding the quality assurance of radiation therapy (RTQA) standards of various trial groups in clinical trials.
  2. Provide a platform for prospective discussions on new RTQA levels, software tools, guidelines and policies of trial groups.
  3. Provide a framework to endorse existing and future RTQA levels and guidelines between various trial groups. Each organization will be able to specify which RTQA procedures from other organizations they endorse and thus accept for future collaborative trials.
  4. Promote high quality RTQA for clinical trials.

Concrete examples:

  1. Promote global harmonization of clinical trials RTQA within the radiotherapy clinical trials community by organizing symposium and forum meetings during international scientific meetings especially recognizing the different approaches to daily radiotherapy (including local QA).
  2. Provide/maintain a website where trial groups can upload and link information
  3. Derive a model for validation/acceptance of national and regional basic dosimetry audits.
  4. Define clear definitions for higher RTQA levels that can be used globally.
  5. Promote research to understand the relative prognostic values, as well as the technical and human resource costs of RTQA approaches to enable the selection of appropriate clinical trial RTQA requirements, especially those involving advancing technologies.

Terms of Reference

Review and approval

These Terms of Reference will be approved by Harmonization Steering Committee , undergo review one year after initial approval, and every 3 years thereafter to ensure relevance and applicability.

Structure and Governance

  1. Executive Group
    • The executive group is comprised of
      • Chair-Elect
      • Chair
      • Past-Chair
    • Chair-Elect cycles to Chair, who cycle to Past-Chair on a two-year term (6 years total).
    • The chair-elect will be selected by the Steering Committee from the full members of the Harmonization Group.
    • The Past-Chair will not be eligible to serve as Chair-Elect for a period of at least two years after completion of their Past-Chair position.
    • The responsibilities of the executive group include
      • Organizing annual meetings and conference calls of the Harmonization Group, ensuring appropriate agendas and minutes are kept and bi-annual newsletters are generated.
      • Setting objectives and plans for the Harmonization Group.
      • Ensuring the objectives of the Harmonization Group are met
  2. Steering Committee.
    • The steering committee is comprised of
      • Executive group
      • 2 additional nominated members.
      • The steering committee will consist of one member from each of the following organizations: EORTC, IROC, TROG, JCOG, and RTTQA. If the nominated member cannot attend committee meetings they must delegate an alternate representative from their organization to ensure the interests of their group are served. Ex officio an EORTC staff member will support the steering committee.
    • The responsibilities of the steering committee include
      • Oversight of the Harmonization Group activities, including financial and administrative aspects
      • Approval of the terms of reference and any amendments thereof
      • Annual review of the activities and progress of the Harmonization Group
      • Ensuring the membership is appropriate, and appointing new members as needed.
  3. Meetings of the group
    • The group will meet in person at least once a year typically coinciding with a major relevant conference such as ASTRO or ESTRO
    • In between meetings, business is conducted via email with all official email addressed to all members of the group.
      • Motions must be in writing and are typically open for discussion for 14 days
      • Voting must be initiated by the chair

Membership

The Harmonization Group addresses multi-disciplinary issues and therefore encourages mutli-disciplinary representation. The inclusion of radiation oncologists, medical physicists, and radiation technologists is actively encouraged to ensure comprehensive evaluation of RTQA issues.

The Harmonization Group was initiated by individuals representing international clinical trial groups. The Group recognizes the importance of contributions by other international trial groups and not-for-profit organizations dedicated to RTQA therefore inviting individuals from these organizations to become member. The Group further recognizes the valuable contribution from professional international radiation oncology societies and manufacturers of radiation oncology equipment therefore inviting individuals from these organizations to become observers.

Members are representatives from groups that are dedicated to the quality assurance of radiation therapy within clinical trials. Member groups include IROC branches not represented on the steering committee and other groups as identified and approved by the GHG. Our member group in addition to the IROC branches is the CCTG. The members need to/have the right to approve /ratify decisions prepared by the steering committee regarding the goals, policies and structure of the Harmonization Group. A quorum is designated as ≥50%. In the case of a split vote, the Harmonization Group Chair will cast the deciding vote. Minority opinions will be provided in any minutes as appropriate.

Observers are individuals with personal expertise from other groups, societies and industry that are recognized as valuable contributors to the quality of radiation therapy within clinical trials. Observers are non-voting and limited to 15 individuals. The IAEA, QUARTET, ESTRO and ACDS are observer groups in the GHG.

Task Groups will be created as needed, including Harmonization Group members, observers and volunteers (i.e., non Harmonization Group members if required) for specific issues or tasks, and will be dissolved when the task has been completed. Each Task Group will be led by a Task Group Chair, appointed by the Harmonization Executive Group

Responsibilities of Harmonization Group Members and Observers

Members and observers that are unable to attend a meeting or conference call may appoint another person to represent their organization with the approval of the Harmonization Executive Group.

  1. Members
    • Participate in Harmonization Group Steering Committee & Members meetings as convened.
    • Attend meetings and conference calls.
    • Review documents sent prior to, and in between meetings and provide advice or comments as requested.
    • Proactively promote the Harmonization Group goals.
    • Review proposals for new members.
    • Lead Task Groups and develop written Task Group reports in conjunction with the Task group members.
  2. Observers
    • Attend meetings and conference calls.
    • Review documents sent prior to, and in between meetings and provide advice or comments as requested.
    • Identify and facilitate areas where their organizations can help to reach the goals of the Harmonization Group.
    • Participate in Task Group activities

Membership & Terms

  1. Term of membership are 3 years and renewable.
  2. Members and observers will be invited by the Harmonization Group Steering Committee or, in certain circumstances be proposed by other interested groups.

Membership includes:

  • Access to the closed harmonization group meetings organized during international scientific meetings.
  • Link to your organizations website on the Harmonization Group website and e-mail newsletters.
  • Access of your organization to and inclusion in the framework of trial group endorsed RTQA procedures presented on the website.
  • Possibility to co-organize a harmonization group meeting and co-shaping the Harmonization Group future.
  • Access of your organization to the database of validated/accepted national and regional basic dosimetry audits.

Fees

  • All steering committee organizations will be requested to contribute a one-time joining fee and a yearly fee to the Harmonization Group. The emolument will be used to cover organizational costs associated with the operation of the group. The fees are set and reviewed yearly by the Steering Committee.