In this guest blog, C Marc Taylor, Chair of the ISRCTN clinical trial registry, discusses the mixed progress of research funders worldwide towards ensuring that all trials are registered and reported. Clinical trials that fail to do so can harm patients and undermine public health, as well as wasting taxpayers’ money.
In the political turmoil of the last few weeks you could be forgiven for missing a milestone on the way to complete reporting of British health research:
On 22 May, the UK government’s National Institute for Health Research (NIHR) launched a detailed policy on the registration and reporting of clinical trials.
This policy makes good on a commitment that the UK, along with other major funders of health research, made at the World Health Organization in May 2017. Their Joint Statement promised that each would publish a policy to implement the transparent registration and reporting agreed in a WHO declaration.
The NIHR’s policy details how it expects trialists to register clinical trials, share data, and disclose results promptly. ISRCTN is its preferred registry. The NIHR has put its weight behind a growing international movement. Of the UK co-signatories in 2017, the Wellcome Trust has a similar policy as does the Medical Research Council. But not yet the Department for International Development.
The rest of Europe? For France, Inserm was a co-signatory but has not published a policy; likewise the Institut Pasteur. And what’s happening at the Research Council of Norway?
The European and Developing Countries Clinical Trials Partnership published its policy in 2018, and the Coalition for Epidemic Preparedness Innovations has done so too.
The German Federal Government was not a signatory in 2017. It now has terms of grant similar to the WHO declaration, but poorly publicised.
Although the Bill and Melinda Gates Foundation was a pioneer in open access, its position on the detail of trial registration and reporting is also hard to find.
What about your favourite funder? If you can’t easily find its registration, data or reporting policies, researchers won’t either. Keep asking until you can find them.
Policies might have got lost down the back of an annex in the conditions of grant. But trialists need clear guidance from the start so that they can plan for the time to keep the public record accurate and then finish the job with competent reporting.
These policies on registration and reporting build on a 20 year collaboration, coordinated by the WHO, around an international network of clinical trial registries, operating within a single framework of standards, and exchanging information through a portal provided by the WHO. The network and portal remove the need to register on more than one registry.
This shifts the focus towards keeping the public record complete and accurate, and making reports of findings and publications readily accessible. There are sixteen primary registries in this system. Between them, they give open access via the WHO portal to standard records describing over half a million studies. With complete reporting of results, what a powerful tool this network could be.
The UK’s primary registry was one of its founders. The ISRCTN registry is an independent international registry which has recorded nearly 10,000 studies in the UK since 2000, and some 8,000 studies led from 60 other countries. The world’s largest registry is the USA’s ClinicalTrials.gov, with over 300,000 studies from over 200 countries.
Unlike ISRCTN, ClinicalTrials.gov operates under US laws which allow for a fine if the rules for registering and reporting are not followed. The UK has not legislated to penalise institutions that fail to report their research. This makes a united front among funders all the more important.
A report last year from the British Parliament’s Science and Technology Committee criticised universities and NHS research centres – with some honourable exceptions – for their very poor record in ensuring disclosure of findings and data from studies they had sponsored.
The Committee recommended the British Health Research Authority (HRA) should take vigorous action against institutions which don’t register studies or report findings promptly. For years, applications to ethics committees have given assurances about registration and reporting. But these assurances are widely ignored in practice.
The HRA will soon consult on a strategy to promote transparency in this and related areas.
Let the Health Research Authority know what action you would support.
Note 1: The contents and opinions expressed in this guest blog are the responsibility of the guest author. TranspariMED has previously summarised studies assessing US research funder policies and global research funder policies. In 2018, TranspariMED jointly with Transparency International and Cochrane wrote to the largest funders worldwide to prompt them on their policies. Later that year, a coalition of 16 French health groups wrote to Inserm and CNRS, challenging them to align with WHO best practices, and a pan-European coalition of 18 health groups called for the planned €100 billion Horizon Europe research and innovation programme to ensure that all trials it funds are fully reported.
Note 2: ISRCTN is currently seeking feedback from users on how to improve its service. Please send your feedback to firstname.lastname@example.org