As clinical trial registration becomes mandatory in Australia, think tank calls for audits and sanct
A think tank report released today by Research4Me has called for “the mandatory requirement for prospective clinical trial registration [to be] supported by audit, incentives and/or sanctions to drive compliance and maintain up-to-date clinical trial registry records.”
Clinical trial registration is an essential precondition for curbing reporting bias and evidence distortion in medicine, which are currently widespread, harming patients, undermining public health, and wasting tax money.
Prospective clinical trial registration became mandatory in Australia in July 2018, but “there are very few ‘sticks’ in Australia to make researchers register and keep their data current on the registers,” the report notes:
“However, across the 250+ human research ethics committees (HRECs) in Australia, trial registration is not monitored equally. There is no requirement to demonstrate on the annual report to an HREC that you have registered and/or updated the trial information on the register. There are currently no sanctions in Australia for noncompliance, though there are a number of initiatives to encourage and enforce prospective registration.”
The new measure, which requires clinical trials to be registered before the recruitment of the first participant, will be fully implemented by January 2019.
The report adds that:
“There is an important role for the public in advocating why it is important that researchers register their trials, provide lay summaries and answer questions about the trials such as age limitations and locations, as well as report their results. Examples of lobbying efforts to increase trial registration and reporting include the UK’s AllTrials activities, and TranspariMED’s Clinical Trials Transparency Guide for Policy Makers produced in collaboration with Transparency International, The Collaboration for Research Integrity and Transparency (CRIT) and Cochrane.”
Other recommendations include:
Mandating the completion of fields on ANZCTR [the Australia and New Zealand trial registry] that are missing from ClinicalTrials.gov records, to ensure ANZCTR is a comprehensive dataset for Australian patients.
Ensuring there are appropriate triggers in place to get people to update the data once registration has been completed.
Educating commercial and academic sponsors to complete and update ANZCTR in real time, to facilitate patient access to comprehensive information
HRECs could require evidence of an updated clinical trial registration record, including the addition of patient recruitment data into the register, when researchers submit their annual report to HRECs. Alternatively, HRECs could use the ANZCTR as their source for annual trial updates and require the ANZCTR to be updated at least each 12 months for HREC to access for this purpose (and to maintain ethics approval).
TranspariMED strongly welcomes the report and endorses its recommendations related to clinical trial transparency.
Policy makers in Australia and New Zealand should also consider the following measures to catch up with other wealthy nations in clinical trial transparency:
Australia’s National Health and Medical Research Council and the Health Research Council of New Zealand should immediately sign up to the WHO Joint statement on public disclosure of results from clinical trials, and fully implement its provisions over the next 12 months. Taxpayers and patients have a right to expect publicly funded medical research to be conducted in line with global best practices, rather than becoming research waste.
Audits should commence as soon as possible, and sanctions need to be phased in rapidly. Long-standing experience from the United States, the European Union and elsewhere shows that positive incentives – while necessary – by themselves will not ensure that every trial is registered and reported. There is no need for Australia and New Zealand to fall prey to the same optimistic illusions.
Australia and New Zealand should consider setting up a National Clinical Trial Audit System similar to that currently under consideration in the UK. Such a system would use HREC records to retrospectively audit whether trials were appropriately registered, and their results published. More information on how such a system would work in practice can be found on the TranspariMED website.
ANZCTR should consider making publicly visible who has failed to update registry records as required, and who has reported trial results and who has not. The various trial trackers developed by the EBM Data Lab provide useful models.
Universities in Australia and New Zealand may benefit from the setting up of an initiative similar to the Clinical Trials Registration and Results Reporting Taskforce in the US, which helps university staff to navigate the trial registration process.