Table 4 Suggested activities to facilitate CTN establishment (Australian Clinical Trials Alliance (ACTA): CTN establishment progress, Unpublished)

Facilitation

Discussions are held between a group of leaders in the field who share an interest in developing a CTN. Typically held by videoconference.

1.

Agreement that establishment of a CTN should be proposed to wider audience and why a CTN would be beneficial prior to further stakeholder consultations.

Meeting with wide group of stakeholders and interested parties, often held face to face.

2.

Agreement that establishment of a CTN should progress and discussion whether it should be facilitating or coordinating.

Assessment of how CTN will operate in existing sector.

3.

Strategy for engagement of colleges, societies, overlapping CTNs, registries, industry, philanthropic organisations, and advocacy groups. May include preliminary discussion of options regarding location of central CTN operations and seed funding.

CTN structure

Governance structure discussed including representation of sub-speciality areas and other relevant disciplines.

4.

Finalisation of initial governance/steering committee and written Terms of Reference.

Consideration of the options for membership structures.

6.

Formalisation of membership structure and strategy for engagement of health service providers and other important stakeholders. System for recording members established.

Business structure discussed and agreed.

7.

Business structure formalised with appropriate documentation (Agreement with parent organisation, constitution, etc.).

Assessment of existing clinical trial infrastructure.

8.

Decision whether to proceed as a facilitating or coordinating CTN.

Meeting of governance committee for strategic planning and discussion of mission, vision, and values.

9.

Formalisation of strategic plan.

CTN launch

Commencement of administration activities.

10.

Seed funding sourced and appointment of an Executive Officer^a.

Communications strategy.

12.

Launch of website/distribution of first member newsletter.

Criteria for endorsement of trials by CTN and authorship criteria discussed and agreed.

13.

Formalisation of authorship and endorsement policy with or without prioritisation.

Clinical trial activities

Trial proposals considered.

14.

Endorsement of first trial.

Commencement of clinical trial conduct.

15.

Conduct foundation trial.

Meeting of the membership.

16.

Inaugural annual scientific meeting.

Wider membership engagement

Strategies to engage the wider membership. May include meetings of sub-diseases or disciplinary areas, special interest areas, educational workshops, for formal mentoring, etc.

17.

Smaller meeting or mentoring programme established.