Clinical Trials: Impact & Quality or CT:IQ was derived after discussion with the founding members about what we want the initiative to really do. Quite simply, our mission 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”.
Put another way, we want to get Australia ‘Thinking Smarter’ about the design and conduct of clinical trials.
ACTA, along with Bellberry, the George Institute and NHMRC Clinical Trials Centre (NHMRC CTC) were the founding members of CT:IQ. This initiative is complementary to all of the aforementioned organisations and should be viewed as a collaborative platform of which ACTA is one, very important, voice representing clinical trials networks. Our vision is to act as a platform for all stakeholder voices to come together and continually improve the clinical trials field in Australia, enabling efficient and effective, patient-centred, clinical trials.
The project scoping undertaken by CT:IQ will ensure full and detailed landscape analysis to ensure that the projects conducted are either filling genuine and critical gaps, or where appropriate directly supports, advocates and dovetails with existing projects being done by ACTA and other organisations in this field.
Yes. They are part of the advisory body of CT:IQ who will provide the strategic direction and the ‘conscience’ of the initiative. They are joined by PBAC/MSAC and international experts.
Many health innovations fail at the stage of final clinical testing and are slow to be incorporated into standard care, often not due to the lack of effectiveness, but because of flaws in the design, execution and analysis of the trial. Clinical trials have also become increasingly expensive and take longer to complete as the regulation and governance becomes more burdensome. This is a barrier to successful clinical translation, implementation and ultimately patient access.
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.
It is important to acknowledge CT:IQ has been many years in the making and will emulate the highly successful FDA-funded Clinical Trials Transformation Initiative(CTTI) in the US. CT:IQ is grateful to the CT:IQ leadership who have provided advice and support and shared materials freely.
The CT:IQ project is receiving funding from MTPConnect for a pilot project which will run until December 2019. In order to progress, there is a requirement for the MTP Connect funds to be matched by other sources. The funding supports CT:IQ infrastructure and provides direct project support.
The matched funding will be sourced through a membership fees whereby organisations pay a fee to join the Steering Committee. Fees are waived for individual patient/consumer representatives and Government Departments; the latter is a result of the MTPConnect funding contract stipulating that government source contributions must not be counted as part of the Contributions and must themselves be matched with equal matching funds as specified in the MTPConnect funding agreement.
In kind contributions are also very welcome and will be acknowledged appropriately, however, these cannot replace financial contributions according to our auditing requirements.
Right now we cannot say for sure, however we know that we have great buy-in and commitment from the most important stakeholders in the Australian Clinical Trials Sector. We know that the active and enthusiastic participation of member organisations will be essential to the success of CT:IQ in having a real impact in creating quality and efficient clinical trials in Australia.
It is fully expected that CT:IQ will last well beyond this pilot phase, but it is important that it only does if there continues to be a need for it to exist. It is critical that CT:IQ remains true to the ethos of having and creating impact and quality of clinical trials.
No, CT:IQ will aim to continuously improve, identify and support best practice in the conduct and design of clinical trials. It will develop solutions to the roadblocks and inefficiencies that impede the value and conduct of all clinical trials in Australia.
The pilot phase is going to tackle 6 projects. These will be nominated by the Executive and Steering Committee members. The types of projects might include:
- 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.
Currently, topics can only be nominated by the Executive or Steering Committee members. This may change as the pilot phase progresses and we may accept topic nominations from the public in the future.
See below for more information on how you might be able to get involved with the Steering Committee.
In line with the success of the CTTI US model, recommendations will be published in peer-reviewed journals, feature on the website, in webinars and at professional meetings and conferences. There may be other tools and resources developed for specific projects as required.
One factor of success will also be including the ‘change agents’ in the process of developing the consensus recommendations. That is, CT:IQ recommendations will come as no surprise to the people who they affect; they will have been part of Project Teams that achieves consensus (not just majority vote) on CT:IQ recommendations.
Part of the requirement of the MTPConnect funding agreement is that the 6 projects make a tangible difference to the Clinical Trials Sector. Therefore we have to ensure that we do measure and evaluate carefully the true effects of CT:IQ. We know that this is often difficult to measure and will be a long process, with ‘soft’ outcomes such as behaviour and culture shift being the first likely indicators of success. We will be utilising Australian expertise in qualitative and quantitative analysis and will develop objective measures of success as part of the topic selection criteria and project planning. We will also be able to learn from the CTTI US experience who are 10 years into the transformation journey and have developed a range of measures that can be translated as appropriate.
For more information contact the Programme Director, LeanneWeekes@ctiq.com.au in the first instance. Depending on availability you and your organisation may be able to express interest in joining the Steering Committee or one of the Project Teams (note Project Team Members do not have to represent an organisation or join the Steering Committee to participate in specific project work).