Terms of Reference

Harmonisation Group

Global Harmonisation of Clinical Trials Radiotherapy QA

 Preamble

Harmonisation 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 harmonising these approaches, international collaboration of clinical trials involving radiotherapy by various trial groups can be significantly enhanced.

Harmonisation Group mission

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

Harmonisation 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 organisation will be able to specify which RTQA procedures from other organisations they endorse and thus accept for future collaborative trials.
  4. Promote high quality RTQA for clinical trials.

Concrete examples:

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

Membership

The Harmonisation 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 Harmonisation Group was initiated by individuals representing international clinical trial groups. The Group recognises the importance of contributions by other international trial groups and not-for-profit organisations dedicated to RTQA therefore inviting individuals from these organisations to become member. The Group further recognises the valuable contribution from professional international radiation oncology societies and manufacturers of radiation oncology equipment therefore inviting individuals from these organisations 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 Harmonisation Group. A quorum is designated as ≥50%. In the case of a split vote, the Harmonisation 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 recognised as valuable contributors to the quality of radiation therapy within clinical trials. Observers are non-voting and limited to 15 individuals. The IAEA, ESTRO and ACDS are observer groups in the GHG.

Task Groups will be created as needed, including Harmonisation Group members, observers and volunteers (i.e., non Harmonisation 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 Harmonisation Executive Group

Responsibilities of Harmonisation Group Members and Observers

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

  • Members

 

    1. Participate in Harmonisation Group Steering Committee & Members meetings as convened.
    2. Attend meetings and conference calls.
    3. Review documents sent prior to, and in between meetings and provide advice or comments as requested.
    4. Proactively promote the Harmonisation Group goals.
    5. Review proposals for new members.
    6. Lead Task Groups and develop written Task Group reports in conjunction with the Task group members.

 

  • Observers

 

    1. Attend meetings and conference calls.
    2. Review documents sent prior to, and in between meetings and provide advice or comments as requested.
    3. Identify and facilitate areas where their organisations can help to reach the goals of the Harmonisation Group.
    4. 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 Harmonisation Group Steering Committee or, in certain circumstances be proposed by other interested groups.

 

Membership includes:

  • Access to the closed harmonisation group meetings organised during international scientific meetings.
  • Link to your organisations website on the Harmonisation Group website and e-mail newsletters.
  • Access of your organisation to and inclusion in the framework of trial group endorsed RTQA procedures presented on the website.
  • Possibility to co-organise a harmonisation group meeting and co-shaping the Harmonisation Group future.
  • Access of your organisation to the database of validated/accepted national and regional basic dosimetry audits.

Fees

  • All steering committee and member organisations (but not observers) will be requested to contribute a one-time joining fee and a yearly fee to the Harmonisation Group. The emolument will be used to cover organisational costs associated with the operation of the group. The fees are set and reviewed yearly by the Steering Committee.
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