BACKGROUND AND AIMS OF ENDORSEMENT
One of the key roles of ANZMUSC is to facilitate high quality clinical trials in the area of musculoskeletal health. The principal ways of doing this are to provide an advisory service for ANZMUSC members planning or conducting a trial (e.g. scientific and operational support to improve the design and conduct of the trial, fund-raising, dissemination of results/implementation plan, engagement with stakeholders, consumer input) and to endorse high quality clinical trials that are being conducted by its members.
Endorsement means more than a ‘rubber-stamp’ of approval. It includes a process of ensuring high quality trial design and conduct but also confers a degree of ‘ownership’ to ANZMUSC members. Trials endorsed by ANZMUSC will need to be prospectively registered, conform to best practice guidelines (e.g. those from the Equator Network) and regulatory standards (e.g. ICH GCP, National Statement), require regular reporting to ANZMUSC and presentation of updates at the annual scientific meeting, and agree to abide by ICMJE authorship guidelines and ANZMUSC Publication policy. ANZMUSC endorsement will provide benefits to both parties: ANZMUSC will gain greater recognition in the research community to enable it to act as a peak body for musculoskeletal research and to achieve its goals. Trialists and their trials will benefit from methodological input, and ANZMUSC endorsement may assist with gaining community and professional acceptance, funding, and implementation.
PROCESS OF ANZMUSC ENDORSEMENT
The following process is required for all studies seeking ANZMUSC endorsement.
All applicants will apply to present their trial in an open forum at an ANZMUSC meeting. Only proposals that fit ANZMUSC criteria will be accepted. Presentations will normally occur at the annual ANZMUSC scientific meeting.
Reviews are completed by two members of the SAC and two consumers of the CAG. Reviewers will be asked to provide comments to the trialists within 2 weeks of submission. In the rare instances where this is not possible, triallists will be notified and an acceptable time frame agreed with the trialist. Trialists will be asked to provide responses to comments to the SAC and CAG within 2 weeks of submission. In the rare instances where this is not possible, the SAC Chair will be notified and an acceptable time frame agreed with the trialist.
SAC Chair and CAG chair to present endorsement recommendations, reviewers’ comments and responses to EC for final decision. The EC will decide to endorse, not endorse, or suggest further development. The applicant is notified of the decision with a formal letter from the Executive Committee within six weeks of submission. This letter lists the conditions and requirements of endorsement that must be accepted by the applicant.
Projects marked for development will need to be revised and resubmitted totheExecutive Committeefor endorsement. This process is expected to involve interaction between the investigators and the SAC / condition specific working group prior to resubmission in order to increase the likelihood of endorsement.
CRITERIA FOR ANZMUSC ENDORSEMENT
Reviewers who are forwarded the application and protocol will treat the protocol as confidential and will not forward the protocol to another party.
CONDITIONS OF ENDORSMENT
Investigators will be required to prospectively register the trial and publish the protocol and should consider making trial data publicly available. They must abide by the ANZMUSC publications policy, and agree to provide annual updates at ANZMUSC meetings. The ANZMUSC Executive reserve the right to withdraw endorsement at any stage if the study is not being conducted in accordance with these conditions, or if irresolvable conflicts of interest arise.
ANZMUSC Endorsement Process
Version 4: December 2020
Approved: February 2021
To proceed with an endorsement application, please email the completed application form and a copy of the trial protocol to email@example.com.