How to get all clinical trials registered and reported - national monitoring explained in five slides

22 Oct 2019

Is achieving 100% clinical trial registration and results reporting a pipe dream? The answer is no – if national governments centrally monitor all clinical trials.

 

Unregistered and unreported clinical trials harm patients, undermine public health, and waste taxpayers’ money. Cases such as the $18 billion (mis)spent on Tamiflu worldwide underline the immense human and financial cost of the problem. Nevertheless, governments have so far largely failed to assume responsibility for protecting patients, public health and public research funds.

 

Meanwhile, other players – including journal editors, research funders, and universities – have tried to fix the problem. As a result of their efforts, trial registration and reporting rates have slowly improved. However, as none of these players covers all trials, achieving 100% compliance will always remain beyond their reach.

 

Only governments have the mandate and power to ensure that all clinical trials conducted within a country – and thus involving their national citizens – follow the rules.

 

Governments are also unique in that they can access the information required to monitor all trials within their country, because each and every clinical trial must pass through a Research Ethics Committee for approval before it starts.

 

The UK government is now planning to centrally monitor all clinical trials within the country. The slides below explain how the system will work.

 

 

 

 

 

 

 

 

 

 

Can central monitoring work in other countries?

 

The UK presents a best case scenario for central clinical trial monitoring because all the documentation from the 64 Research Ethics Committees nationwide is already being centrally archived. Thus, all information required for monitoring is already available in one place.

 

However, there is nothing to stop other governments from also centrally collecting Research Ethics Committees’ approval documents and using them to monitor trial registration and reporting.

 

How much will it cost to monitor all clinical trials?

 

Compared to the immense cost of research waste generated when clinical trials fail to report results, the projected one million Euro price tag of the UK monitoring system is marginal.

 

Monitoring clinical trials on a national level is not only the right thing to do, it is also a highly cost-effective intervention.

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