Australian Industry Welcomes Govt Plans To Streamline Clinical Trial Process
This article was originally published in SRA
The Australian pharmaceutical industry body Medicines Australia has welcomed a pre-election commitment by the federal government to promote a more coordinated approach to the way that clinical trials are approved and conducted across the country1.
Australia's ability to retain and attract more clinical trials has been hindered by the "myriad of regulations which can change from state to state as well as hospital to hospital," the association said on May 20 – International Clinical Trials Day. The requirements for ethics committee approval can also vary depending on the location, it added.
It said it therefore welcomed health minister Sussan Ley's promise, in advance of the federal election on July 2, "to bring a more harmonized approach to these regulations and a national co-ordination point of contact to help negotiate contracts, prices, regulations and ethical approvals for multi-site clinical trials."
In addition, a pledge by the government to implement a national communications strategy so that relevant patient groups and clinicians can be better utilized to identify patients eligible for trials will help to address the problem of patients missing out on trials because they could not be identified in time, the association said.
The changes announced by the minister would "help to make Australia a more attractive destination for clinical trials which is great news for patients, great news for local researchers and welcome news for our members," the association declared. It added that it would work with the federal government as well as all the state and territory governments to ensure the changes were made.
Continuing Efforts
Efforts have been under way for some time to improve the clinical trials environment in Australia, which is perceived as fragmented and inconsistent, particularly where multi-jurisdictional trials are concerned.
Addressing the Medicines Australia annual dinner in Canberra in March this year2, Ley said these efforts had already borne fruit, with the government having contributed A$1.9m ($1.4m) to making approvals more streamlined and consistent, including the development of a single ethics review application form.
She also mentioned the "Clinical Trials Ready" initiative for site identification, the "Good Practice Process" (GPP) for site assessment and authorization, and moves to address the barriers to trial recruitment and retention through better functionality of the Australian Clinical Trials website.
She cautioned that while these projects were "good work", no single entity held all the levers to effect change across the sector. However, she said she was "pleased by feedback I have had from some pharmaceutical companies that they are starting to see improvements in timelines for ethics and governance review of clinical trials."
Medicines Australia and the government were working together on activities for International Clinical Trials Day to promote the importance of trials to the Australian economy, she said, adding: "I think there is room for Medicines Australia to provide more assistance in developing relationships between sponsors of clinical trials and trial sites."
Of the initiatives currently under way, the most high profile are the Clinical Trials Ready project and the GPP, both of them run by the National Health and Medical Research Council (NHRMC).
"Clinical Trials Ready"
This initiative is intended to help recognize trial sites that are "ready, willing and able to carry out high-quality trials in a timely, transparent and efficient manner," the NHRMC says3.
The major benefit of the initiative is a greater awareness of the ability and capacity of Australian sites to conduct clinical trials and recruit effectively. This in turn should lead to more clinical trials taking place in Australia as a result of "competitive start-up times, use of transparent costing frameworks and processes, and the high quality of the researchers and data."
A consultation on the project was run last year, and the results were published in November. These showed that for 90% of respondents, being recognized as "ready, willing and able" would make a trial site more attractive to potential sponsors.
The key desired characteristics of the initiative were identified as: efficient, reliable, timely and predictable governance/ethics approval procedures; transparency of sites, costs and participant recruitment mechanisms; and that research needed to be seen as core business and embedded in the culture of the clinical trial site.
"The majority view was that the initiative should be a transparent process, managed by NHMRC, with an expert oversight body to advise on the development, implementation and management of the initiative."
The NHMRC is setting up an advisory group to finalize the criteria and mechanism by which sites will be recognized and to advise on management of the Clinical Trials Ready initiative. It will then pilot the initiative at a number of different clinical trial sites to ensure feasibility, and then proceed with the launch of the initiative.
"Good Practice Process"
Following extensive consultation with stakeholders, the NHMRC developed the GPP for the site assessment and site authorization phases of clinical trials research governance4.
First published last year, and now at the pilot study phase, the GPP is intended to allow efficient and effective site assessment and authorization, and should lead to a reduction in the time it takes to commence a clinical trial.
The NHMRC said at the time that a wide range of stakeholders, including the pharmaceutical industry and clinical trial practitioners, had raised concerns about the length of time taken to get clinical trials up and running in Australia, and particularly about the time taken to complete research governance. "Reducing delays in the commencement of clinical trials will help to increase Australia’s attractiveness as a destination for global sponsors to conduct clinical trials," it declared.
It proposes two key improvements: an increased commitment to planning, preparation and ongoing support for clinical trials within those institutions where clinical trials are conducted, and a change to the order in which the activities within the assessment and authorization process are conducted, with key assessment activities occurring much earlier.
The NHMRC has run some pilot studies to test the feasibility of implementing the GPP at 16 sites throughout Australia. It is now analyzing information obtained from the pilot sites and is considering further testing of the GPP.
Once details on the effectiveness of the GPP have been collected, and any modifications made, the NHMRC says, "it is expected that the Good Practice Process will be implemented at all clinical trials sites to facilitate a standardised approach to clinical trials research governance."
The NHMRC is also revising its position statement on Monitoring and Reporting of Safety for Clinical Trials, which has been released for public comment, with a closing date of May 27.
Work At The CTJWG
Elsewhere, the Clinical Trials Jurisdictional Working Group was set up in July 2014 to identify and address barriers to, and enablers of, multi-jurisdictional trials and improve Australia's international competitiveness.
The CTJWG has developed what it calls a Clinical Trials Framework for Action, in collaboration with the Clinical Trials Advisory Committee, which advises the departments of industry and health on progress with clinical trial reform5.
The government says that the group has consulted widely on the framework with a range of key stakeholders with an interest in clinical trials, including professional organizations, front-line industry representatives and contract research organizations, as well as Commonwealth and state and territory bodies.
References
- Medicines Australia release, May 20, 2016, https://medicinesaustralia.com.au/media-release/promise-to-reduce-barriers-to-clinical-trials-will-benefit-patients/
- Sussan Ley speech, March 15, 2016, http://www.health.gov.au/internet/ministers/publishing.nsf/Content/health-mediarel-yr2016-ley160315.htm
- NHMRC, Clinical Trials Ready initiative, website accessed May 20, 2016, www.nhmrc.gov.au/research/clinical-trials/nhmrc-clinical-trials-initiatives/development-clinical-trials-ready-initiat
- NHMRC, Good Practice Process, website accessed May 20, 2016, www.nhmrc.gov.au/_files_nhmrc/file/research/clinical_trials/good_practice_process_for_research_governance_150724.pdf
- NHMRC, Clinical Trials Jurisdictional Working Group activities, website accessed May 20, 2016, www.australianclinicaltrials.gov.au/australian-government-clinical-trials-initiatives