For those looking to conduct late-phase trials in the U.S. or in APAC, there may be some hesitation around the logistics of transitioning a trial from country to country. Luckily, there are well-honed pathways for moving a trial from Australia to another country that prioritize seamless transition and uninterrupted regulatory compliance. If your team is considering whether this strategy might benefit your trial, explore the options available to you.
What Are The Benefits Of Conducting Clinical Trials In Australia?
There are several major benefits to conducting a clinical trial in Australia. First and foremost, there is no IND requirement in Australia to initiate a first-in-human (FIH) trial. Australia’s health authority, the Therapeutic Goods Administration (TGA), offers two pathways to initiating a trial: the Clinical Trial Notification (CTN) scheme and the Clinical Trial Approval (CTA) scheme.
In the CTN scheme, which is most widely used, sponsors submit an online notification form prior to conducting a clinical trial. The CTN scheme requires that an ethics board reviews the proposed trial protocol and any relevant data to assess the trial’s design, safety, and efficacy. Once approved, a notification is sent to the TGA. This process generally takes only five to six weeks from submission to approval and is meant to save companies’ time and money. The CTA pathway is mandated for high-risk, Class 4 biologicals and requires a 30- to 50-day review from the TGA.
In Australia, full GMP material is not mandated for Phase 1 trials. Beyond that, there is also a 43.5% R&D tax rebate for U.S. clients and small biotechs that conduct trials in Australia, which can further mitigate high expenses. Australia offers an ICH-controlled environment for producing high-quality clinical data that is accepted by the FDA, EMA, PMDA, and other major global regulators. Thanks to these offerings, Australia has become an appealing destination for initiating early-phase clinical trials that will later be transferred to other regions.
Which Regulatory Considerations Should Be Top Of Mind?
One of the key challenges in moving a clinical trial from one region to another is maintaining consistency in trial design and execution. Differences in regulatory requirements, standards of care, data collection, and patient management practices can introduce variability that complicates the interpretation of trial results. A consistent trial design and protocol across regions are critical throughout this process. The more uniform your protocols are, the higher assurance you have of data compatibility and regulatory alignment between the TGA and other regulatory authorities.
Mitigating risks throughout the lifespan of a clinical program, which includes multi-regional trials, is essential to reducing delays and minimizing costs. Partnering with a single CRO across different regions is a strategic approach that can offer major benefits. This approach facilitates continuity by allowing personnel overlap between trial phases, preserving institutional knowledge, incorporating past learnings, and ensuring consistent feedback from regulators and ethics committees. Such continuity can streamline operations and enhance trial efficiency. Furthermore, teams working under the same CRO will have a more fluid working relationship, turning potential challenges into advantages. Some of the potential regulatory challenges include handling different regulatory review and approval times when trying to orchestrate a simultaneous global clinical trial submission, managing and responding to requests across multiple agencies.
Avance Clinical’s integrated approach ensures a seamless transition from Australia to the U.S. or other APAC countries by maintaining continuity in trial management and ensuring that data generated in Australia is fully compatible with the requirements of later-stage trials in the U.S. and/or Asia. Working with Avance Clinical’s Scientific and Regulatory Affairs team through the transition from an early to a later-phase clinical trial will ensure that past learnings, including site-specific considerations, potential efficiencies generated through regulatory bodies’ cooperation, e.g., Project Orbis, and strategic choice and timing of interactions with different regulators will be carefully considered. For example, this might include the timing of the submission of a Pediatric Study Plan in the U.S. and a Pediatric Investigation Plan in Europe in relation to an end of Phase 2 meeting.
Avance Clinical operationalizes global dose escalation and dose expansion trials across two or three continents through secure data storage, standardized collection, and efficient sharing of clinical trial data across trial sites to enable data integrity and regulatory compliance. The Avance Clinical team strategically structures services, such as Medical writing, across Australia, the broader APAC region, and the U.S. to maximize the benefit from the R&D Tax Incentive for sponsors.
Are CROs Prepared To Tackle Multi-Regional Trials?
Avance Clinical partners with clients to strategically plan their first-in-human (FIH) clinical trials with a clear focus on the longer-term objectives of advancing to Phase 2 and 3 trials across multiple regions. By integrating global considerations into early trial design, the team ensures a seamless transition through development phases and optimizes efficiency and regulatory alignment. This approach positions clients for success in achieving their clinical and commercial milestones.
Avance Clinical created the GlobalReady approach to accommodate drug sponsors that want to conduct early-phase clinical trials in Australia and transition to later-phase trials in the U.S. or Southeast Asia. As part of the GlobalReady design, Avance Clinical’s experts focus on establishing consistent trial protocols and standardizing data collection so that all phases of a trial are well-aligned, regardless of their region.
Team members also work to secure regulatory alignment between the various regulatory bodies to mitigate risk, reduce delays, and keep costs to a minimum. Avance Clinical facilitates this effort by establishing regional experts in Australia, New Zealand, North America, Southeast Asia, and Europe who ensure that every regulatory prerequisite is carefully considered. With boots on the ground to monitor local regulatory markets, local experts can flag relevant regulatory trends that help sponsors determine the ideal protocol design and site selection strategies. The team aids sponsors as they navigate country-specific regulatory frameworks and aims to maximize the probability of approvals via sound trial execution.
By leveraging GlobalReady, your team will gain expert insight into the protocol designs that work well for health authorities and ethics committees as well as guidance on how to address your target product profile. For example, if you complete a Phase 1 oncology trial in Australia and want to move to the U.S. for Phase 2, Avance Clinical experts will help determine the best time to apply for a breakthrough designation or fast-track eligibility. Avance Clinical regulatory experts are well informed of the accelerated pathways available and use this knowledge to help clients reach marketing authorization as quickly as possible.
Avance Clinical also assists clients with IND preparation and submissions, as well as coordinating review by the FDA. The team can also organize pre-IND meetings and offer preclinical expertise. Avance Clinical toxicologists have supported preclinical development programs and Initial Targeted Engagement for Regulatory Advice on CBER/CDER Products (INTERACT) meetings with the FDA.
How Does A CRO Provide Smooth Trial Management?
The COVID-19 pandemic has not only re-emphasized the importance of well-designed clinical trials but highlighted the need for large-scale clinical trials structured according to a master protocol in a coordinated and collaborative manner. There is also a need for structures and incentives to enable faster data sharing of anonymized datasets for randomized clinical trials, and a need to provide similar opportunities to those in high-income countries for clinical trial research conducted in low-resource regions with considerably less research funding.
Smooth trial management largely relies on project management teams; however, scientific and regulatory team members can provide valuable assistance on this front. When partnering with Avance Clinical, your team will have access to a functional regulatory affairs lead; this is a team member that assumes oversight for the clinical trial across different countries and sites, which helps verify that information is never being lost between the sponsor, CRO, sites, and regulatory bodies. When questions or protocol changes come in from a regulatory body, the regulatory affairs lead works to coordinate submissions, establish efficiencies, and address all regulatory concerns, bearing in mind the importance of a streamlined global protocol with no or limited iterations across different regions, whether it is a master protocol or not.
This approach aids clients in carrying out multi-regional clinical trials by ensuring that protocols are harmonized and minimizes differences in trial conduct across regions which can negatively impact the ability to detect an overall treatment effect as well as the ability to examine consistency of treatment effects at the analysis stage.
Avance Clinical also strives to work with a diverse patient pool. Trials are conducted across varied ethnic groups, which helps enhance the quality and applicability of data for future markets. Ensuring these results are generalizable across different ethnic groups and compliant with all regulatory authorities allows sponsors to best utilize the data for future marketing authorization.
Is This Option Right For My Trial?
If you want to increase speed and reduce costs while still procuring high-quality data for your trial, consider the impact of launching an early-phase clinical trial in Australia. With the right CRO partnership, you can seamlessly transfer an early-phase clinical trial from Australia to another country, including the U.S., and with harmonized protocols and expert regulatory guidance at hand, your drug development programs will benefit from a development strategy based on a harmonized global execution approach.
Find out more about Avance Clinical’s global scientific and regulatory affairs capabilities.
