1 Preamble
1. 1 Vision
Many national and international clinical trials involving radiotherapy are conducted 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. Harmonization and streamlining of Quality Assurance (QA) between the international groups could help reduce the QA related workload for individual centers. Secondly, broader acceptance of the trial results and thus the impact of the trial can be achieved. Thirdly, several publications suggest that appropriate quality assurance of radiotherapy results in stronger statistical power of the trial results.
Approaches to QA for multi-institutional radiotherapy clinical trials have been developed independently throughout regions of the world. By harmonizing these approaches, trial results also become comparable and transferrable and international collaboration for clinical trials involving radiotherapy by various trial groups can be significantly enhanced.
1.2 Mission
To promote harmonization of radiotherapy quality assurance for clinical trials between groups globally.
1.3 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.
Concrete examples:
1) Promote global harmonization of clinical trials RTQA within the radiotherapy clinical trials community by organizing 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.
2 Structure and Governance
2.1 Core and observer organizations
The Harmonization Group was initiated by individuals representing international clinical trial groups. Currently five organizations make up the core of the Harmonization Group. They are EORTC, IROC, TROG, JCOG and RTTQA. Representatives from these organizations form the leadership of the Harmonization Group as outlined below. Decisions are made by the core organizations with their representatives acting as conduits.
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 join. 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 observer organizations.
2.2 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 core organizations of the Harmonization Group.
- In general and where possible, the executive group positions should have varied expertise (e.g., radiation oncologist, medical physicist, RTT).
- 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.
2.3 Steering Committee
The steering committee is comprised of:
- Executive group
- Additional nominated members representing the core organizations not represented in the executive group. Currently, as we have five core organizations this means two additional members.
The steering committee will consist of one member from each of the core 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 the GHG secretary will support the steering committee.
The responsibilities of the steering committee include to
- have oversight of the Harmonization Group activities, including financial and administrative aspects
- approve the terms of reference and any amendments thereof
- review the activities and progress of the Harmonization Group annually
- ensure the membership is appropriate and appoint new members as needed
- approve GHG endorsed publications including recommendations and guidelines
- foster their implementation in the respective trial groups
- approve the creation, participants and lifetime of new subcommittees
2.4 Subcommittees
The aim of a subcommittee is to conduct clinical trial QA related activity on a specific project topic which has been selected and considered relevant by the GHG for consensus.
A subcommittee is comprised of:
- at least one responsible chair, who should represent one of the core organizations (shared chair positions are possible if it serves the subcommittee’s purpose)
- representatives from the majority of the core organizations
- other active participants committed to the purpose of the subcommittee
The process of forming a subcommittee on a project is as follows:
1. At least three of the core organizations consider the project worthy
2. Interested members outline the project for the proposed subcommittee and submit a brief formal proposal including the aims, objectives and deliverables to the Steering Committee (Proposal form in appendix 1)
3. Steering Committee reviews and formally endorses the Subcommittee
4. Subcommittee resumes work on the project and documents progress
5. Subcommittee chair sends regular updates to Steering Committee and presents at GHG meetings to all members
6. Drafts of any publications are submitted to Steering Committee for approval
The responsibilities of the subcommittee chair(s) include to:
- submit the subcommittee proposal to the steering committee
- communicate any change from the approved proposal to the steering committee
- maintain regular meetings, minutes and actions
- ensure all members of the sub-committee stay active
- submit regular executive summaries prior to the SC meetings
3 Membership
3.1 Individual Membership
Membership is open to anyone working in the field of Radiation Therapy Clinical Trials and being interested in Quality Assurance. Individuals need to register their interest to become members and
- Specify if they represent one of the core or observer organizations and give a reason why they want to be a member
- State that they will respect these ToR
Membership applications (Appendix 2) will be reviewed and approved by the Steering Committee. At certain intervals, membership will be reviewed and members will be asked to confirm their continued interest in membership.
Members are expected to:
- Participate in meetings and conference calls as convened.
- Review documents sent prior to, and in between meetings and provide advice or comments as requested.
- Proactively promote the Harmonization Group goals.
- Participate in the work of appropriate subcommittees
Membership includes:
· Access to the closed harmonization group meetings organized during international scientific meetings.
3.2 Organizational Membership
3.2.1 Observer Organizations
Authorized members of organizations active in or supporting clinical trials QA can apply for observer status of their organization with the GHG. Decisions of acceptance will be made by the Steering Committee.
Benefits of observer status with the GHG include:
· Link to the organization’s website on the Harmonization Group website and e-mail newsletters.
· Access of the organization to and inclusion in the framework of trial group endorsed RTQA procedures presented on the website.
3.2.2 Core Organizations
By decision of the Steering committee and via a change of these Terms of Reference, organizations can become core organizations of the Harmonization Group.
3.3 Fees
The core organizations will be requested to contribute 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.
4 Review and approval
These Terms of Reference will be approved by the Harmonization Steering Committee, undergo review one year after initial approval, and every 3 years thereafter to ensure relevance and applicability.
Appendix 1 – Subcommittee project proposal form
Appendix 2 – Membership application and renewal form
(digital version will be created)