“Our mission is to get Australia Thinking Smarter about the conduct of clinical trials.” The mission of CT:IQ is “to develop and implement recommendations that will improve the impact, quality and efficiency of clinical trials, leading to more rapid, lower cost and higher quality evaluation of healthcare interventions in Australia”. Our aim is to get Australia Thinking Smarter about the design and conduct of clinical trials. We’ve already heard about the role of trials in Australia: in our healthcare system and in our economy. We think we can do more, and we can do better. We believe this will lead to a more meaningful integration of clinical trials into the Australian health system, resulting in better healthcare and better outcomes for patients, participants and the community as a whole. Striving for continuous improvement and identifying and supporting best practice is a collective responsibility. Together we will identify challenges that face our trials, and together we will explore, solve and implement solutions that will help to improve the impact and quality of trials, and therefore drive the outcomes of trials. The investigator-led and industry trials sectors, along with Governments, regulators, patients, research funders and trial participants have a shared interest in: - Streamlining/fit for purpose clinical trial approval/governance processes. - Increasing the efficiency of recruitment, retention and data monitoring. - Building better research partnerships between trial sponsors, groups that conduct trials, and participant groups to enhance feasibility and quality. - Ensuring the trials are conducted in ways that are sensitive to the needs of all stakeholders and respectful of participants. - Improving the design of studies in order to ensure the results are as reliable as possible, while being conducted efficiently.

CT:IQ WILL… Maximise efficiency Create consensus Communicate broadly Measure Impact Follow Evidence-Based approach Consider all stakeholders CT:IQ WILL… Based on established methodologies. Evidence based processes research with published outcomes. Where we can, we will learn from and build on existing work. Gather evidence on implementation and impact. Publish outcomes.

Core activities that CT:IQ may undertake Development of consensus recommendations Partnership with Australian organisations Assessment of International recommendations EVIDENCE GATHERING Implementation of tools & guidelines to improve clinical trials Impact measurement IMPLEMENTATION & IMPACT Key to the methodology is that CT:IQ will take an evidence-based approach to clinical trial issues. This will be the approach and the focus both when considering improvement areas, and when measuring the impact of work done. CTIQ will work openly and cooperatively, seeking out partnerships and collaborators where relevant to topic areas. Indeed, some projects may well be led by connected groups. CTIQ will take into account that we work in an international context for clinical trials. International recommendations and requirements will be taken into account. Where needed, work will be undertaken to contextualise guidance to the Australian setting. Finally, CTIQ and the Steering Committee will work together to develop consensus statements, recognising that clinical trials can be a complex matter with multiple important perspectives. CTIQ workstreams will incorporate impact measurement, and results will be published. Importantly, outcomes will be communicated openly with other agencies sharing this journey, such as CTTI and related bodies in other countries. Core activities that CT:IQ may undertake

consensus development planning/scoping implementation Steering committee chosen Executive committee (in the interest of expediency) 2018 2019 2020 6 PILOT PHASE PROJECTS (MTPConnect funded) CT:IQ will focus on making the most impactful changes on the issues identified, prioritised and selected by the Executive and the Steering Committees. Project funded for 6 projects over 2 years. First 2 will be selected by the initial Executive Committee. This is largely driven by timeframes, and the need to get started. The remaining 4 projects will be selected from the topics nominated and prioritised by the Steering Committee. During the pilot programme we will work to ensure that there is a distribution of topics across the sector: for example projects in pharma and medical devices, trial design, site matters, participant issues, trial technologies. There are broadly three types of project: CTTI output contextualised to the Aus environment, and impact measured. Implementation of best practice guidance. De novo projects. We expect topics to include: - eInformation and eConsent Novel trial designs Telehealth Governance Remote monitoring, remote delivery of trials Best practice patient engagement We fully expect that there will be more topics than the 6 we’re funded for, so our challenge will be to make a success of the Pilot project, with the aim of developing an on-going vehicle for Continuous Improvement in Clinical Trial that can continue to roll on in the following years with pressing questions in due course.

Possible CT:IQ topics… Registry-randomised and registry-linked trials Best practice for Data Safety Monitoring Committees Real world evidence & trial design Best practices for GP pathways to clinical trials Advancing novel trial designs Trial design for effectiveness and reimbursement Teletrials: structures, technologies, conduct issues Best practices for patient engagement Repurposing of new drugs We expect topics to include: - eInformation and eConsent Novel trial designs Telehealth Governance Remote monitoring, remote delivery of trials Best practice patient engagement We fully expect that there will be more topics than the 6 we’re funded for, so our challenge will be to make a success of the Pilot project, with the aim of developing an on-going vehicle for Continuous Improvement in Clinical Trial that can continue to roll on in the following years with pressing questions in due course.

Proposed Governance Structure for CT:IQ developing consensus Implementation planning Project teams Up to 40 stakeholder organisational members Steering Committee topic prioritisation/selection supporting existing activities industry consumers others Executive Committee decision making accountability (including budget) +TGA +PBAC/MSAC + others Advisory Body strategic direction Proposed Governance Structure for CT:IQ The Governance structure – and I’m actually going to start in the centre of this diagram. Founding collaborators have been acting to date as the Executive Committee. This group will be broadened to include broad representation from across the sector. This group will have responsibility for… Collaborators who join CTIQ as members will be able to nominate an individual to the Steering Committee. This group will provide the overview to the programme: nominating topic areas and prioritising them. Once the projects have been selected, project teams will be established for each one – and I’ll talk a bit more about those in a second. The initiative has the support of an Advisory Board, the membership of which is currently being finalised. It will have representation from the international groups undertaking similar work, and from the regulatory agencies here. The Advisory board will provide horizon scanning and feedback. It will…

Steering Committee Membership Nominate topics & prioritise projects Regular reports & public acknowledgement Named representative on the Steering Committee Time commitment of 4-12 hours/month Active participation (seek, engage, promote, collaborate etc) Membership fees (based on organisation type [$1,000-20,000] for pilot project duration i.e. until December 2019) So, what’s involved? Collaboration members will be able to nominate to the Steering Committee, and take part in the activities outlined. Time Commitment is expected to average a day a month over the 2 year period, with active participation to support the progress ofCT:IQ. Membership fees will be used as matched funding, along with a grant from Bellberry, and matched funding from MTPConnect. Fees vary according to the nature of the organisation, and cover the 2 year duration of the pilot. There is some flexibility on invoice dating during the pilot period, and the best advice really is to contact Rebecca if you would like a specific conversation about your situation. Why would I join now? To be able to have a voice in selecting the projects for the next 2 years.

Proposed Project Roles and Responsibilities (planning, evidence, meeting & workshops, recommendations, presentations) Team Leader (4-12 hrs/month) Steers, sets objectives, decides Team Members (4-8 hrs/month) Identifies, develops, interprets, provides input CT:IQ Staff Tracks, provides support, organises, liaises Full collaboration membership won’t be for everyone, and if it’s not, then there are still opportunities to get involved. Practically speaking, projects will require between 1 and 3 team leaders, depending on complexity, and up to 20 team members per project. Each project will have the support of a dedicated CT:IQ Project Manager to support the project team. Resources will be made available to each project team for activities up to and including prototyping. Project outcomes will be published, so team members will have the opportunity to get involved in paper authoring and publications.

info@CTIQ.com.au CTIQ.com.au