Síle Lane is on a mission to challenge misrepresentation of science and evidence. She is leading the AllTrials campaign, which makes institutions accountable to the House of Commons Science and Technology Committee if they fail to improve reporting of clinical trials…
AllTrials advocates for clinical trial results to be reported on clinical trial registers first, and only then in journal papers.
Uploading results onto a clinical trial register comes with a lot of advantages. It means the results are always publicly accessible (not behind a pay wall). It means results are more complete and honest than they might be in a journal paper because the researcher is forced to report against a standard template, whereas it’s easy to leave out “uninteresting” results in a paper (i.e. to just report on secondary outcomes, if the primary outcome showed no effect).
In a number of places around the world including the US and the EU it is the law that results are reported onto the national register. Clinical trial registers are publicly accessible databases of information about clinical trials. The largest ones are, generally, run by governments – for example, the US's government's ClinicalTrials.gov (run by the FDA) and the EU's EU Clinical Trial Register (run by the EMA).
A number of the world's largest funders have said that they will look at researchers’ past record of reporting or withholding results when making decisions about granting new funds
In the EU the rule is that all clinical trials on the EU register (and that is all EU clinical trials) must report results onto the register within 12 months of the end of the trial. We have built the trial tracker tools – websites where we pull in information from clinical trial registers, assess which trials have results associated with them or not and therefore which institutes and companies are reporting and who is not. Based on our EU clinical trial tracker, around 40% of them have not.
Betrayal of trust Clinical involve hundreds, sometimes thousands, of people – patients with the condition under investigation. Most who volunteer to be part of the trial know it may or may not help them personally but understand that findings about the medicine and their condition would be shared with researchers and doctors and would go to help people like them in the future. When trial findings are not shared it's a massive betrayal of their trust.
Withholding results is research misconduct. This is according to growing number of professional and learned societies. And funders are mandating publication of results, whatever the outcome, as conditions of grant. A number of the world's largest funders have said that they will look at researchers’ past record of reporting or withholding results when making decisions about granting new funds.
The Common's Science and Technology Committee announced the start of a review period in January. The Committee said that they would be monitoring progress for six months and that when they open the inquiry again in the autumn they would publish the results of that monitoring. (What with the uncertainty around the Parliamentary timetable and other things a precise date hasn’t been set.)
The six months that universities and NHS Trusts were given in January to improve their registration and reporting rates is now up. At AllTrials we are now crunching the data ready to recommend to the Committee which universities they should call to Parliament to quiz about lack of progress or to champion for good progress.
Sense about Science campaigns are ensuring open discussion of research and evidence, particularly around decisions which impact on our lives. We say that anyone who wants to should be able to ask for evidence behind a claim they see and expect to get an answer. We also run the Ask for Evidence campaign to help people do this and to understand the evidence they receive in response.
Síle Lane is head of international campaigns and policy for Sense About Science, a charity that challenges misrepresentation of science and evidence.