Embarking on the clinical trial approval process in Australia can feel like traversing a maze of regulations and paperwork. But with a clear understanding of the process, researchers can confidently navigate the complexities and ensure a smooth journey to compliance and successful initiation. From the initial groundwork to the post-approval process, following these six steps will ensure your clinical trial is a resounding success.
1. Preparation and planning
When undertaking clinical trials in Australia, meticulous preparation and planning lay the foundation for a successful study. Preparation and planning involves:
- Protocol development: Creating a comprehensive outline of the trial’s objectives, methodology and procedures. The resulting document should provide a clear roadmap for researchers, ethical review boards, and regulatory authorities.
- Investigator selection: Identifying experienced and qualified investigators with relevant expertise in the therapeutic area under investigation. These individuals oversee the trial to ensure adherence to protocols and to safeguard the well-being of participants.
- Identifying study sites: Assessing potential sites based on accessibility, demographics, and logistical considerations. Selecting appropriate study sites can help ensure a diverse participant pool and contribute to the overall efficiency and success of the trial.
The importance of preparation and planning cannot be understated - successfully following these steps sets the stage for navigating the submission process.
2. Submission process
On completion of preparation and planning, researchers must compile and submit various forms and documents to the required regulatory bodies. In Australia, two key schemes play a significant role in the submission process: the Clinical Trial Notification (CTN) and the Clinical Trial Application (CTA).
The CTN scheme is designed for low-risk clinical trials with an ‘unapproved’ therapeutic good. It simply requires notifying the Therapeutic Goods Administration (TGA) of your intention to conduct the trial. This notification form can be accessed and submitted online and does not require a formal review by the regulatory authority before the commencement of the trial.
By contrast, the CTA scheme is an approval process for higher-risk clinical trials with ‘unapproved’ therapeutic goods. It requires researchers to submit a comprehensive, paper-based application for formal evaluation. The application includes detailed information on the trial’s design, methodology, safety measures and the investigation product. The TGA conducts a thorough review to assess the trial’s compliance with ethical and safety standards before granting approval.
Before beginning the submission process, researchers should be well-versed in the nuances of the scheme relevant to their clinical trial. This knowledge is fundamental for successful regulatory reviews post-submission.
3. Regulatory review
On submission of a clinical trial through the CTA scheme, the application will undergo a thorough regulatory review by the TGA based on three key pillars:
- Safety: The trial application is scrutinized to ensure that robust safety measures will be in place, prioritising the protection and well-being of study participants.
- Efficacy: The trial’s potential benefits and posed effectiveness are evaluated to ensure it will provide meaningful and reliable outcomes.
- Compliance: The application is reviewed rigorously to ensure that researchers will conduct the study per the Australian clinical trial handbook.
On completion of the regulatory review, the application is then considered based on its ethical merits.
4. Ethics review
An ethics review, a pivotal step in the clinical trial approval process, is conducted by the Human Research Ethics Committee (HREC). During the review, the committee assesses the trial’s design, participant recruitment methods and the informed consent process to ensure the trial protects the rights of participants. This thorough examination confirms that the study aligns with key ethical considerations in clinical trials and that potential benefits outweigh potential risks.
5. Approval timelines
When navigating the clinical trial approval process in Australia, it’s common for the process to take several months. Factors that could influence timelines include the complexity of the study, the need for revisions during the review process and the responsiveness of the research team in addressing queries. The type of clinical trial application (CTN vs. CTA) can also impact approval timelines. Acknowledging these variables and having realistic expectations about the approval timeline is integral to the process.
6. Post-approval process
The post-approval phase signifies a shift from anticipation to active engagement in the clinical trial. Following approval, site initiation visits, and data collection are the logical next steps:
- Site initiation visits: Involve introducing the trial protocol to participating sites, ensuring that investigators and site personnel are well-versed in the study's requirements. This step is pivotal for establishing a collaborative and informed research environment.
- Data collection: Researchers diligently gather and document relevant information, adhering to ethical and regulatory standards, and the trial’s approved protocol.
Continuous communication and collaboration between research teams and participating sites are critical during this phase, fostering a seamless and accountable post-approval process.
Undertaking the clinical trial approval process in Australia involves meticulous planning, a strong submission and navigating regulatory and ethical requirements. By following these six key steps, researchers can establish a solid foundation for successful study initiation and progression.
If you want to learn more about how you can successfully navigate clinical research in Australia with a team of professionals who are committed to safe and ethical studies, get in touch with us today.
