‘Asking for perfect compliance is unreasonable.’
Lots of companies and some small non-company sponsors have 100% compliance.
‘Some of the trials you flag as unreported have been reported in academic journal papers.’
The EU rules are clear that results must be posted directly onto the EU trials register, in a standard format. This is with good reason. Reporting on a register has several advantages over academic journal publication: it is much easier to locate results; it is much easier to track compliance; and registers mandate important information that must be included in the results report. By contrast, there is extensive evidence to show that results reports in academic journals are incomplete, of poorer quality than registry reports, and less complete on important issues such as adverse events data.
In any case, the researchers checked a small sample of non-compliant trials to see if they really are reported in academic journals, even though this is inadequate: half were not2.
‘The researcher who ran the trial doesn’t work at this institution anymore.’
This is a tougher one. The institute has failed to ensure adequate reporting by its staff and now can’t remedy that easily. If an institute is listed on the register, it remains responsible for reporting results, just as it would with, for example, a grant report. Before giving this excuse, we think sponsors should show that they have attempted to track down the results and the researcher to remedy the situation. And universities should urgently put policies in place, to make sure this situation doesn’t arise again in the future!
‘These trials are from 10 years ago/an abandoned trial/not interesting… so the results wouldn’t be useful for anything now.’
The law in Europe is very clear: every trial on the EU clinical trials register must report results directly onto the register. This is for good reason. Trials with an “uninteresting” or “negative” result provide information about what doesn’t work. Terminated trials that have already collected some data on some patients can contain important insights. Research on abandoned treatments can shed light on other drugs in the same class, on adverse event risks, or on new uses of older treatments.
‘There’s no money left in the research grant for anyone to spend time reporting results.’
This is just flat out against the law, and usually against the terms of the funding. It’s also unethical. Trials are conducted to inform patient care. If you don’t report the results of your trial, you might as well have never done it. We question whether trialists or institutions should be conducting further research, if they are willing to make this excuse.
‘There’s no career incentive to report negative results.’
This is unethical, and increasingly untrue. Major funders and ethics approval bodies are starting to scrutinise the reporting history of researchers applying for new approvals. Some professional bodies now view non-reporting as misconduct.
‘But this is my research. I own the results.’
This is true. For research conducted on yourself and yourself alone. If you have conducted a trial on patients, then you have obligations to those patients, to your funders, to the law, and to all patients.