Reporting Clinical Trial Results – The Why and the How

May 3, 2019 Sile Lane

Researchers have clear scientific, ethical, and moral obligations to report the results of their research, especially researchers who work with human research participants. Yet more than half of the results from clinical trials go unreported. This is shocking.

Scientists have known about this problem for four decades but things are only now beginning to change. That’s because the issue is appearing on public and parliamentary agendas for the first time.

At the beginning of this year, the UK’s House of Commons Science and Technology Select Committee announced that it will be monitoring the performance of UK universities and NHS Trusts. If the institutes fail to improve transparency, they could be pulled in front of the committee this summer.

This, alongside pressure from Sense about Science’s AllTrials campaign and other groups, will hopefully spur underperformers into action. However, there is a concern that some researchers are unaware of their legal obligations or do not know how results should be reported. So why should you report results, whose responsibility is it, and what processes need to be followed?

Why Report Trial Results?

Researchers have an overriding set of ethical and legal obligations to report results from clinical trials. Conducting future research could also depend on timely reporting, with research funders and ethics committees increasingly examining track records before issuing the go ahead to fund and approve a new clinical trial.

In many circumstances, it is mandatory under EU and US law that clinical trial register entries are complete and accurate. Ensuring register entries are accurate and results are reported should be part of the standard procedure for running any trial.

Reporting and updating result is a fairly straightforward process, and free, so there are no barriers to uploading your trial results.

When Do I Legally Have to Report Results?

All trials carried out in the EU are subject to the EU’s clinical trials reporting guidelines and legislation, and that means that results must be recorded on the EU register. All trials carried out in the EU have been added to the European EU Clinical Trial Register since June 2004, and this is where results should be recorded.

The EU reporting requirements may also apply to certain trials conducted outside the EU, such as pediatric trials that will be part of a marketing authorization in the EU.

In the US, most trials are required to be registered on the US register ClinicalTrials.gov. Many interventional clinical trials of drugs and devices, and all clinical trials funded by the US National Institutes of Health, are required to be registered on ClinicalTrials.gov and to report results there under the FDAAA 2007 law and other related regulations.

Whose Responsibility Is It?

The designated responsible party, commonly referred to as a sponsor, is liable for ensuring that information about a clinical trial is kept up to date and that results are reported in a timely manner. The sponsor tends to be the company or institution which has oversight of the trial rather than the research funder or any individual researcher. However, in some cases, the Primary Investigator (PI) of the trial will act as a sponsor or accept some responsibility for the data on the registry entry.

How Do You Register and Update Results?

Uploading and updating results is a relatively straightforward process. In the EU, for example, entries on the EU clinical trial register are made up of information submitted to the National Competent Authority that originally gave the researcher permission to run the clinical trial. Results information is the only information a researcher can add to EU CTR directly. For everything else, the information must go through the national authority.

Once logged in to the EudraCT system, researchers will see a template results form which they can fill in, adding additional information into free text fields where necessary. Once the form is filled in and submitted, staff at EudraCT will review the information. They may ask the researcher for clarifications or to resolve conflicting or questionable information.

Once validated, the EMA’s system will make most results information public, according to the regulations set out here.

What if I get stuck?

The Sense about Science AllTrials campaign has created a step-by-step guide to uploading results to clinical trials registers in the EU and the US. If researchers come across specific issues when attempting to upload results, they may have to contact relevant organizations in order to overcome any issues.

Researchers can also check if any of the trials they were involved in running are overdue reporting results using AllTrials’s tracking tools. Check out the tracker for the EU clinical trial register here and the tracker for the US register here.

 

About the Author

Sile Lane

Head of International Campaigns and Policy, Sense About Science //

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