Proposed regulatory changes for clinical trials of medical devices

We asked for feedback on two proposals to:

• improve the safety, performance, and quality of medical devices in Australia
• improve health outcomes and confidence in products for patients who need medical devices.

The proposals were:

1. introducing TGA oversight of clinical trials of certain high-risk invasive or implantable medical devices that have not been used or studied before in humans
2. including medical devices in the Good Clinical Practice (GCP) Inspection Program.

The proposals aimed to strengthen the rights, safety, and well-being of medical device clinical trial participants and improve the quality of clinical trial data. The proposals also aimed to align the TGA with the level of regulatory oversight in comparable countries.

Sixty-six (66) stakeholders submitted a response to the consultation, including:

• sponsors
• manufacturers
• contract research organisations
• universities
• health services
• human research ethics committees
• patient advocacy organisations
• professional medical organisations
• government bodies
• members of the public.

Most respondents (including clinicians and patient groups) were in favour of increasing regulatory oversight of clinical trials of high-risk medical devices. Those respondents suggested that the proposal would:

• relieve the burden on research offices and Human Research Ethics Committees (HRECs), particularly where the HREC does not possess the required expertise
• increase alignment with comparable overseas jurisdictions such as the US, Canada, Japan, and the UK where the regulator is involved in reviewing applications to conduct clinical trials of investigational medical devices and issuing its approval before the trial can commence
• enhance participant safety, noting the potentially catastrophic implications of device failure in a clinical trial
• strengthen public confidence and align with existing community expectations that clinical trials in Australia are conducted according to international best practice.

Supportive respondents also:

• highlighted recent reports of safety issues with medical devices and suggested regulator oversight is essential in the context of anticipated growth in new and emerging technologies that pose novel risks to participants
• noted that failure of an implanted investigational medical device can have more serious adverse consequences than failure of an investigational medicine as it may require a second surgery to explant the defective device, which can be risky in itself
• noted some concerns about the potential to deter clinical trials from Australia
• raised the variability in quality and medical device expertise in the 200+ HRECs operating around Australia as a concern and rationale for requiring TGA oversight for the highest risk device trials.

A minority of respondents (including medical device industry and contract research organisations) were not in favour of mandatory TGA oversight of clinical trials of certain high-risk medical devices and expressed concern on the following items:

• a potential increase in administrative burden, costs, and start-up timeline
• negative effect on clinical trial investment with significant economic flow-on losses
• no problems with the existing system or evidence for the need for more regulatory scrutiny
• potential for patients to lose access to innovative technologies
• perceived lack of expertise in the TGA to assess certain medical devices
• potential for the TGA to duplicate work now done by the HREC.

There was broad support for including medical devices in the GCP Inspection Program. These respondents suggested the proposal would:

• improve patient safety and data integrity
• strengthen safety oversight of device trials
• elevate compliance and adherence to study protocols and regulations
• provide insights about the conduct of device trials
• align with international best practice and comparable overseas regulators
• align with community expectations that medical devices are subject to independent scrutiny in the same way as medicines and biologicals.

Thank you to everyone who provided feedback.

After reflecting on the feedback, we held targeted discussions with stakeholders to clarify the intent of the proposals and to seek their specific input on potential alternative options and details including HREC processes. We also developed alternative proposals for TGA oversight of clinical trials of certain high risk medical devices without having a deleterious effect on administrative burden, costs and start-up timelines through:

1. reviewing existing forms and TGA powers under the notification pathway to improve and make specific information mandatory when a clinical trial is notified
2. including clinical trials of medical devices in the GCP Inspection Program
3. supporting the Australian Commission on Safety and Quality in Health Care clinical trials reforms and strengthening HREC capabilities and consistency to support medical device clinical trials through a national accreditation scheme

Outcomes of all the consultations and proposed alternative proposals were provided to the Minister for Health and Aged Care for consideration.