We recently checked up on progress against a 2019 piece of advocacy that we worked on in collaboration with patient advocate Charlotte Korte, from Consumer Advocacy Alliance. We are happy to report that there has been good progress, though there is more to do.
In 2019 TINZ’s CEO Julie Haggie and Charlotte Korte together, with the support of Transparimed, advocated to influence the NZ Health Research Council and the Ministry of Health to recommend that New Zealand sign up to the WHO Joint statement on public disclosure of results from clinical trials.
This statement commits the signatories to the early registration of any research study involving human subjects , into a publicly accessible database. It also commits parties to ensuring that researchers make research results publicly available in a timely manner (negative and inconclusive as well as positive results).
In July 2020 the Ministry of Health advised that the WHO had added the Health Research Council as a signatory to the joint statement.
Currently, whilst there appears to be reasonably good registration of clinical trials, not all are registered prospectively, and there is no mandating of reporting on results. Transparimed -who are working to end evidence distortion in medicine - report “huge transparency gaps in New Zealand clinical trials.” Compliance has not been well monitored and lack of compliance has not been sanctioned.
Good News
So what has changed since the signing of the joint statement? Did we make a difference?
In 2020 the HRC partnered with the Ministry of Health to co-fund a study on clinical trial systems and data infrastructure in New Zealand’s public healthcare system. The report from this research is due to be launched some time in the next few months and the recommendations will be directed specifically to the Ministry of Health, Te Whatu Ora (Health NZ) and Te Aka Whai Ora (the Māori Health Authority) to implement.
We also hear that we can expect to see in the near future publication of a research article that reports on HRC-funded RCTs between 1999-2017 and investigates trial registration, results publication, and time-to-publication in the near future. Both of these reports provide some baseline evidence to support recommendations.
A challenge for moving at greater speed than probably should have occurred is that we are dependent on the resourcing and technical competency of the Australian New Zealand Clinical Trials Registry (ANZCTR). This is a worthy initiative but needs to be developed into a more seamless tool enabling registration and results reporting across Australasia.
Till Bruckner from Transparimed has just had a paper published on JAMA Network on a cross-sectional study that he led of the 21 largest non-multilateral public and philanthropic funders in Europe. This study found that funders implemented a mean of 36% of WHO best practices in clinical trial transparency. Performance varied widely among funders, and some practices were more widely adopted than others. The study used the CONSORT 2010 checklist of information to include when reporting a randomised trial.
So, some progress, more to be done, and congratulations to the Ministry of Health, Health Research Council and civil society advocates for the progress that has been made.
Keep working to improve
We appreciate that there are a lot of interdependencies, with the Australian register and our health system is at the early stages of huge changes. Still, we need to keep our eye on this particular aspect of our health system. We must push hard for more transparency for those who are clinical trial participants, or intending to be, and more transparency to enable better decision-making around funding.
Benefits to clinical trial transparency
There are multiple benefits of greater transparency in both registration and results reporting:
- Patient access to results from previously completed clinical trials can inform trial enrolment decisions.
- Doctors, professional bodies and the general public will be able to access the results from a larger proportion of clinical trials.
- Reduced reporting bias allows for more informed decisions in licensure and marketing, in public health policy recommendations and financing decisions by public procurement bodies.
- More efficient research funding allocation. More efficient development of interventions.
- Ethical requirements for dissemination of information will be better met, potentially increasing trust.
- The scientific state-of-the-art will be based on a more complete cross-section of clinical trial data.
