Policy and Procedure Discussion Notes

Below is the feedback, discussion points/comments and resolution/outcome for each issue discussed at the Annual Scientific Meeting for each document/policy. The ANZMUSC Executive Officer will act on the resolutions and update all documents as indicated. All documents will be considered working documents and might evolve over time.

 

 

ANZMUSC Structure. 48 responses. 96% YES, 4% NO

– accepted with some minor modification as below

Feedback Discussion Points/Comments Resolution/Outcome
–          There seem to be too many layers.  It is not clear how intercommunication between committees and the EC will be optimised for the purposes of responding to multiple recommendations from different committees –          General disagreement with this feedback.  Attendees did not feel structure was too complex –          Nil
–          It is not wise to include junior trialists as voting members of a SAG.  Membership would be encouraged, but not voting rights –          No difference between junior and senior trialists

–          Wording related to senior and junior to be removed.

–          Chair to ensure all members appropriate.

–          It is not clear if the members of the Funders Group will be commercial or government or NFP.  There is considerable risk of COIs and issues of IP and confidentiality when reviewing proposals in this case.

 

–          Need clear policy for commercial interaction

–          Need clear terms of reference for funders group

–          Funders are not those who sponsor trials (consumer groups, prof associations, health authorities, health funds)

–          Pharma funding for infrastructure?

–          Funders group will not review proposals

–          Some consumer groups have pharma funding

–          EC to create terms of reference around commercial interaction

–          EC clarify in terms of reference that funders are not sponsoring trials (only infrastructure)

–          EC to ask ACTA if any other groups use pharma funding for infrastructure

–          May need to treat each funder on individual basis as they will have different needs

–          Are funders individuals or a group?

–          Representatives from funders to sit on the group

–          Good to have all funders in the same room or prevent one group having undue influence

–          Noted that some funder groups do not collaborate

–          Funders chair non-voting member of EC

–          Common model

–          No role in decisions

–          Call it a ‘stakeholder group’

 

–          What skills are represented in this ‘skills-based’ Executive group?

 

–          Should be open to all full members

–          EC open to all Full members regardless of qualifications

–          EC appointment to be via expression of interest in 2017. WG will continue in its current form until 2017.

–          Can’t have every discipline represented

–          WG to EG. Exercise Scientists have a vital contribution to a group focused on MS conditions –          Should be open to all full members –          SAG to be appointed following call for expressions of interest. All disciplines encouraged to attend.
–          Duration of appointments –          2 years –          Length of appointments to be included in terms of reference documents

 

 

MEMBERSHIP POLICY. 48 responses. 96% YES, 4% NO

– accepted with some minor modifications as below

Feedback Discussion Points/Comments Resolution/Outcome

–          Who assesses applications?

 

–          Confirm they are eligible for full membership

–          Common in other networks

–          EC to assess members post 2017. Assessment is looking for involvement in clinical trials

–          Should associate members be charged?

 

–          Expensive for consumers

–          Funders will have membership as part of funding agreement

–          Associate Members will not be charged
–          Add fracture/stress fracture? In area of interest –          Included in “other” –          Add to membership form
–          Add Dietician/Exercise physiologist in Qualifications

–          Pharmacist also missing

–          Included in “other”

–          Add to membership form
 

–          Associate members includes early career researchers who do not yet meet full membership.

–          Associate members cannot elect

–          Document to clarify that
  –          full members to have published a trial –          Document to clarify that
  –          International associates

–          Can be associate members

–          to be clarified in document

–          People who leave Australia permanently  

–          To revert to associate members

–          to be clarified in document

–          Associate to Full membership transition

–          Don’t have to be nominated again.

–          Yearly renewal to capture that (are your details and membership level the same as last year)

–          Document to clarify that
 

–          Membership form to ask are you happy to review?

–          Would you consider being on an ANZMUSC committee?

–          Document to clarify that
  –          Proof of trial activity could be ANZCTR or publication –          Document to clarify that
  –          New members welcome anytime –          Registration form to be online at all times

 

 

CONSUMER ADVISORY GROUP TERMS OF REFERENCE. 48 responses. 100% YES

– accepted with some minor modifications as below

Feedback Discussion Points/Comments Resolution/Outcome
–          Chair appointment length –          2 years –          Stated in terms of reference already
–          No of members –          Amount of work will dictate the number of members

–          Amount of work will dictate the number of members.

–          Needs to be enough noting that some members may  not always be able to contribute so need a pool, will also depend upon volume of work

–          How are CAG recruited?

 

–          From other groups? –          CAG members to be recruited through Health Consumer Forum.
–          Is there any evaluation of performance?  

–          CAG performance to be reviewed by EC.

–          Performance review to be included in terms of reference

–          How will the CAG application be assessed?

–          What is the benchmark for each criteria?

 

–          CAG members obtained through CHF are already “trained” consumers.

–          Suitability will be at the discretion of the EC.

–          CAG need ‘a strong interest in MSK CT research’. How is this evaluated? –          Only interested people will apply presumably –          Membership calls for CAG via CHF will call for those with an interest in MSK CTs. No evaluation of interest level, likely that only those with interest will apply

–          Important to describe funding support within the ToR (travel and accommodation)

–          It doesn’t seem necessary to remunerate the advisory group as it is part of the ordinary remit of NFP advocacy groups?

 

–          Out of pocket expenses should be paid to facilitate attendance

–          Remuneration is another question – noted that ethics committees sit without remuneration, not unrealistic to expect them to contribute their time for free

–          ANZMUSC will cover out of pocket expenses and CAG can apply for remuneration (sitting fee)

–          Membership fees to cover this.

–          ‘With opportunities to attend workshops and participate in committee meetings’ – does ANZMUSC pay these costs? –          Reasonable for ANZMUSC to pay

–          ANZMUSC will pay for CAG members not already “trained”

 

–          ‘Unless your role is within health ….’ this is ambiguous. What really does it mean? For example if volunteers for a health organisations put up their hands, are they considered to be having a role in health? –          Remove line –          Line will be deleted
–          Change wording to ‘you can apply for remuneration’ understanding some people may choose not too –          CAG can apply for remuneration (sitting fee) –          Wording to be changed to reflect that application for sitting fee is possible but may not have funds to provide

–          What will the training workshop entail?

 

–          CHF conducts training, or Anne McKenzie also “trains consumers” –          EC to find suitable training courses based on what other networks use.
–          ‘CAG members will be invited to attend the annual two-day scientific meeting’. Does ANZMUSC pay these costs? –          Out of pocket seems reasonable = sitting fee

–          ANZMUSC will cover out of pocket expenses and CAG can apply for remuneration (sitting fee).

–          Membership fees to cover this

–          Concern that researchers feeding back to CAG will slow progress of trial planning. Also who will adjudicate this process?

–          Is CAG for advice or sign off?

–          CAG to provide advice and sign off because don’t want consumer only involved at the end – they need to add advice at the beginning

–          CAG won’t review all proposals

–          SAG will send CAG completed proposals to review

–          SAG will adjudicate process

–          CAG will be able to comment on incomplete proposals at open forum sessions (early input)

–          Document to be amended to clarify this
–          Breach of terms of reference etc. What does this mean? On what grounds will a breach precipitate a dismissal? Who will judge? Over what time? –          Should have the ability to remove members if they are not acting appropriately –          Inappropriate behaviour and consequences at the discretion of the CAG Chair and EC
  –          CAG to be involved in priority setting –          CAG will be involved in priority setting
  –          Arthritis and Osteoporosis Victoria conducted “patient information support” review with consumer feedback –          ANZMUSC will use this and other sources in the lead up to priority setting

 

 

 

 

ENDORSEMENT. 53 responses. 85% YES, 15% NO

– agreed with minor amendments as below

Feedback Discussion Points/Comments Resolution/Outcome
–          What is the definition of a clinical trial for the purposes of ANZMUSC?

–          WHO definition

Doesn’t have to be treatment, can be an intervention

–          Document to include this
–          Project needs to conform to ANZMUSC research priorities but who sets these? –          Priority setting not yet done

–          Priority setting will be done by ANZMUSC in future

–          EC to decide until priority setting complete

–          Do trials need to be multi-centre? If about increasing power already covered in high quality design. Problem for implementation trials focussed on a particular centre. Also trials recruiting from the community can be run through 1 academic centre e.g.; footwear trial. Area may be extremely niche so no other site available, or idea so novel no-one else brave enough to join?

–          How will multi-site be defined? Does this relate to recruitment, treatment, trial management or all? Trials can be managed from one centre but recruit nationwide.

 

 

–          Trials are enhanced by being multicentre (quicker to recruit and reach targets)

–          Presentation at Open forums provides the opportunity to establish connections and turn proposals into multi-site studies

–          General support for multi-centre, or with a potential to be multi-centre to be prioritised over single centre studies

–          Is multi-centre simply more than 1?

–          Proposals don’t have to be multi-centre, but those going for endorsement must be

–          Aim to have ANZMUSC EO scope the locations of ANZMUSC members to determine their potential to be multi-centre (identify skills and needs)

–          ANZMUSC endorsement not needed for funding (but will be helpful)

–          Proposals don’t have to be multi-centre, but multi-centre required for endorsement?

–          Multi-centre to be defined in document – recruitment from more than one site

–          Must be Multi-centre or have the potential to become multicentre

–          Proposals that fit ANMZUSC criteria will be prioritised

–          One reason for multicentre requirement is workload issue (we won’t have time to see and endorse every single site trial and our priority should be on high quality large trials that answer the most important questions

 

–          What happens if applicants can’t attend to present trial at forum? –          Doesn’t have to be CI who presents –          Open-Forum application to state this

–          How will reviewers be selected? How are they selected for expertise?

–          How will review quality be established and maintained?

 

–          SAG will contain spread of expertise

–          Reviewers only full members or associate members also?

–          Consumers are only associate members, so  associate members should review

–          Nominations for reviewers prior to open-forum

–          “high quality” criteria as per other advisory/review groups. SAG to take the lead on “high quality”

 

–          Review policy to be written to indicate how reviewers will be selected, review time frame, review expectations

–          Any COI will need to be declared by reviewers and all committees and dealt with as appropriate (follow NHMRC guidance regarding how they deal with COI for grant reviewers).

–          ANZMUSC to write policy for this.

–          At what stage of development is trial presentation recommended/required?

 

–          All stages welcome

–          Useful to have separate sessions for fully developed trials and un-developed trials

–          Open-Forum submission document to clarify this

–          Separate sessions to be conducted at next meeting (if possible)

–          It states discussion of proposal will be led by a reviewer – why not by the researcher? By TC? Reduce load on ANZMUSC? –          Reviewer –led works fine for others –          Reviewer led to be trialled in open forum sessions

–          Will reviewers have to give feedback publicly given criticism may be harsh? A detailed written summary may be more useful and honest than a 3 minute verbal review?

–          Will the review process be confidential or open?

–          Verbal and anonymous reviews will be trialled at the meeting

–          Would be good to have reviewer response prior to meeting

–          Verbal reviews preferred at meeting

–          Written review feedback to be provided prior to open forum in future

–          How is approval to proceed after presentation decided?

 

–          SAG will write 2 weeks after forum inviting them to submit for endorsement or suggesting further development –          To be written in document
–          How will workload of scientific committee be managed? Workload may spiral around grant time & committee busy with own grants –          SAG to be given sufficient time to review proposals given commitments

–          Call for proposals to occur 1 month before forum to allow review time

 

–          Will ANZMUSC priorities be aligned with NHMRC priorities? What evidence would be needed to confirm the significance of the question? –          ANZMUSC to set priorities –          Priority Setting starting with a SR of other priority setting for MSK
–          Conditions for endorsed trials too onerous? E.g.: annual ANZMUSC presentations/reports; will discourage engagement with ANZMUSC –          Short written reports can be read out by any team member –          Short annual report form to be created

–          How will COI’s be dealt with?

–          COI on proposals (commercial, and relationships with other investigators)

–          NHMRC principles should be adopted with consideration for ANZMUSC professional relationships

–          SAG to decide if COI is non- existent, low or high

–          COI to be included in proposal/protocol submission form
–          COI for EC –          EC member must step aside –          COI to be included in proposal/protocol submission
–          Discord between SAG and CAG –          Any discord to be considered by EC –          Any discord to be considered by EC
–          Can clinicians propose ideas? ANZMUSC could email clinicians to suggest trial priorities that clinician researchers could later work up –          Part of priority setting –          Will be considered in priority setting
–          Given that ANZMUSC members must have published at least 1 CT how will ECRs or PhD led projects be endorsed? –          Senior team member to be involved, but doesn’t have to be the PI –          To be clarified in document that “At least one investigator must be a full member”
–          There seem to be too many layers in the approval process.  It will be unwieldy and slow.  It is not clear how intercommunication between committees and the EC will be optimised for the purposes of responding to multiple recommendations from different committees.

–          Open Forum will improve trials

–          SAG to review complete proposals and then EC to endorse

–          Not considered too complex by attendees

–          Nil
–          Do consumers read all proposals?

–          CAG only read before endorsement to be less onerous (no pre-forum reading)

–          SAG reads protocols before endorsement and flags questions for consumers to comment

–          CAG as a whole will only see proposal if SAG or EC flags it

–          CAG to decide the depth of consumer engagement

–          SAG Chair to read proposals and flag questions for them to review

–          EC can also flag issues for CAG review before endorsement

–          Document to clarify this

 

–          Framework for questioning decision   –          Appeal process to be added to endorsement process
–          Portion of people that say yes to a proposal   –          EC to decide how much is enough and write in document (kidney group – majority, and not anonymous)
–          Liability of endorsement –          ANZMUSC endorses protocol –          EC to write a misconduct policy based on code of responsible conduct of research but liability for misconduct should be worn by the trialists

 

 

PUBLICATION. 53 responses. 83% YES, 17% NO

– agreed with minor amendments

Feedback Discussion Points/Comments Resolution/Outcome
–          There needs to be a guaranteed 3 week turnaround otherwise these processes will
slow down publication
–          3 week guarantee –          3 week turn around to be written into document
–          ANZMUSC CT network should not have default authorship on all publications.
Acknowledgement should be sufficient.

 

–          Acknowledgement and affiliation?

–          ‘corporate’ author’?

–          For other CTNs, all members are trialists, but not all ANZMUSC members will be trialists

–          Funders wouldn’t be acknowledged (they support infrastructure not trials)

–          Authors could list ANZMUSC membership as an affiliation

–          Acknowledgement required where ICEJM guidelines are met, corporate authorship may be appropriate.

–          Document to state this

–          ANZMUSC endorsement (not authorship, unless justified; no default authorship).

 

 

–          Does the Exec need to be informed of a resubmission to an alternative journal?

 

–          Depends on whether change is complete or not

–          Notification needed to maintain updated status of trial publications

–          Yes – document to detail this, but won’t require review unless large changes are made.

–          Participating institutions should be listed in order of contribution not alphabetically.

 

–          Sentence to be removed –          Sentence to be removed
–          All publications reviewed by voting member of ANZMUSC exec. Huge workload for
these people?

 

–          Review is about ensuring it still meets ANZMSUSC endorsement criteria – not re-write of manuscript

–          SAG members should review

–          EC Chair should review

–          Purpose of manuscript review to be expressed in document

–          PI’s own study data whether or not they are endorsed.

 

–          Remove sentence –          Remove sentence

–          What is a ‘reasonable period of time’?

 

–          Length of time determined  by sites and writing committee –          Clarify in document

–          Publication policy –seems thorough and complete. Initially, should be considered as an operational draft??

 

  –          Updated document will be considered a working draft

 

 

END OF MEETING DISCUSSION POINTS AND QUESTIONS
1) Should the Working Group/Executive Committee stay as is? = yes

2) Anonymous or open review? – open verbal review with written feedback before forum

3) Template for submission required (to be on website)

4) Template for review required (to be on website)

5) Template for presentation required (to be on website)

6) Separate forums needed for “new ideas” vs those fully worked up – easier to comment when you know how developed a trial is

7) New ideas good for learning, fully developed trials good for building brand

8) Clearer instructions for reviewers – clarify they are not endorsing

9) Good to have 6 monthly meetings. – Good to get near-miss feedback from ANZMUSC looking at NHMRC criteria

10) Priority setting supported. Priority setting paper first paper for ANZMUSC?

11) EC to send comments about whether or not trials are to be endorsed within 2 weeks

12) EC to draft letter of support that all ANZMUSC members could send to their local MP/ other potential infrastructure supporters

13) EO will scope sites trial capabilities

14) ANZMUSC website to have a repository of shareable guidelines and SOPS for clinical trials

15) Could have proposals on website for extra comment (would need to be a secured site)