Influencing Increased Transparency in Clinical Trials
The work focused on engaging with regulators for a general review of the legislation governing medications. The goal was to influence stronger compliance around clinical trial registers, lodging and reporting. Working with partners (TranspaiMED and Mesh Down Under), the work sought to encourage the New Zealand Government to subscribe to the World Health Organisation joint statement on public disclosure of results from clinical trials.
In 2019 92% of clinical trials were missing results on the regional registry in New Zealand, which poses serious issues for transparency and for public health. National ethics guidelines in New Zealand still do not mandate the full reporting of trial outcomes. Instead, they merely recommend that results are reported. Compliance is not monitored, and lack of compliance is not sanctioned.
- TI NZ and Mesh Down Under met with the Health Research Council, to better understand the extent of transparency in clinical trial registration and reporting.Consultation
- TINZ made a submission to the Therapeutic Products Regulatory Scheme consultation run by the Ministry of Health (MoH). The consultation proposed a Therapeutic Products Bill to replace the Medicines Act 1981, establishing a new regulatory scheme for therapeutic products including medicines and medical devices. Implementation of new policy & practice
- Advocated to the Ministry of Health and Health Research Council that one of them should sign up to the World Health Organisation (WHO) joint statement on public disclosure of results from clinical trials.
- The Ministry of Health has indicated its support for NZ signing up to the WHO joint statement on public disclosure of results from clinical trials. Whilst it cannot currently sign up (due to the rules on who can sign) it has recommended that the Health Research Council is the appropriate body, and has recommended to Council that this be progressed.
- There is potential for the change identified above to improve access by the public to information on current clinical trials.
- Connections with senior leadership at the Ministry of Health were established. This supported advocacy in a trusted environment.
- It was beneficial to highlighted the advantages to the Ministry of Health and the Health Research Council of engaging with NGO stakeholders and signing the WHO protocol.
- Skype and teleconferences was used to connect people without huge cost (health services are under stress in NZ).
- The submissions and advocacy resonated were designed to resonate with thinking that had been going on at the Ministry of Health and the Health Research Council.