One of the key roles of ANZMUSC is to facilitate high quality clinical trials in the area of musculoskeletal conditions. The principle ways of doing this are to provide an advisory service for ANZMUSC members planning a trial (e.g design & 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 means any funding applications can use the ANZMUSC brand to indicate the study is of high scientific merit. 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 agreement to abide by the ANZMUSC publication policy. ANZMUSC endorsement will provide benefits to both parties: ANZMUSC will gain importance 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. This will occur at one of the twice-yearly meetings of ANZMUSC. Discussion of each proposal will be led by a reviewer appointed by the Scientific Committee, who will have reviewed the proposal beforehand.
- If agreed to at the ANZMUSC meeting (following the open forum), the application is submitted to the Scientific Committee (later, this may be done via condition-specific working groups).
- The application will be reviewed by 2 research reviewers and 1 consumer and a decision made by the committee whether to recommend endorsement, enable further development of the proposed trial to meet endorsement standards or reject.
- The applicant is notified of the decision within 4 weeks of submission.
- Projects marked for development will need to be revised and resubmitted to the committee for endorsement. This process is expected to involve interaction between the investigators and the Scientific Committee / condition specific working group prior to resubmission in order to increase the likelihood of endorsement.
- The final decision will be made by the Executive committee, usually on the basis of the recommendation of the Scientific Committee.
CRITERIA FOR ANZMUSC ENDORSEMENT
Only clinical trials in the field of musculoskeletal health will be considered.
- Must satisfy an ANZMUSC research priority (reflecting important disease burden and an important evidence or evidence-practice gap)
- Must present evidence confirming that the research question is one that the clinical and/or consumer community want answered.
- Must be of high quality (e.g. minimising risk of bias, ensuring appropriate power) and include an economic evaluation and process measures where relevant
- Must be feasible (reflecting cost, logistics, track record and likely recruitment rate)
- Must show strong potential to change practice and/or policy (reflecting academic impact, implementation, and generalisability)
- Must be multicentre (to encourage collaboration, increase power and increase implementation of findings)
- Chief investigator must be a registered member of the ANZMUSC Clinical Trials Group.
Investigators will be required to prospectively register the trial, publish the protocol and statistical analysis plan, and makes plans for implementation of the results and making trial data publicly available, abide by ANZMUSC publications policy, and agree to provide annual updates at the ANZMUSC meetings.