Today the House of @CommonsSTC Sci Tech committee publish an outstanding report on trials transparency.
The world of medicine is rapidly dividing into two:
- a new, contemporary medicine, orgs and people who understand data;
- the old, and outdated.
THREAD...
The world of medicine is rapidly dividing into two:
- a new, contemporary medicine, orgs and people who understand data;
- the old, and outdated.
THREAD...
@CommonsSTC ... this @CommonsSTC report is truly magnificent. It summarises the evidence on non-reporting and mis-reporting of clinical trials. It explains the rules. It explains why it matters. And it holds feet to the fire. It makes concrete recommendations, requiring replies....
@CommonsSTC ... It is interesting to see how public bodies have responded to this process.
For example, the Health Research Authority is responsible for running ethics committees throughout the country @HRA_Latest The HRA receive substantial and reasonable criticism in the report...
For example, the Health Research Authority is responsible for running ethics committees throughout the country @HRA_Latest The HRA receive substantial and reasonable criticism in the report...
@CommonsSTC @HRA_Latest ... How does HRA respond to this criticism? Admirably!
"Having reflected on the evidence submitted to the committee by ourselves and others earlier this year, we have already begun to take action on some of the areas raised in today’s report."...
hra.nhs.uk/about-us/news-…
"Having reflected on the evidence submitted to the committee by ourselves and others earlier this year, we have already begun to take action on some of the areas raised in today’s report."...
hra.nhs.uk/about-us/news-…
.. they have reflected, they recognise there is a problem, they are taking action. They are looking at the practicalities of fixing the problem. This is great stuff, but it's also great leadership, and what a public body should do, when presented with ethical breaches....
.. the response from Public Health England @PHE_uk by contrast is very concerning.
Public Health England have failed to comply with EU rules that require all trial results to be reported directly onto the EU trials register within 12 months of completion...
Public Health England have failed to comply with EU rules that require all trial results to be reported directly onto the EU trials register within 12 months of completion...
@PHE_uk ... these rules exist for good reason. Academic journals, sadly, permit trialists to mis-report their trial results. So the rules on trial registers require people to post their results on the register properly in structured format...
@PHE_uk ...As we explain in our BMJ paper, two large cohort studies show that structured results reports present more complete data on both results and adverse events than traditional journal publications... Complying with this is also, you know, THE LAW...
bmj.com/content/362/bm…
bmj.com/content/362/bm…
@PHE_uk ... Now, Public Health England has not complied with these reporting rules.
I nearly FELL OVER when I was shown this.
Remember, our site checks reporting compliance for thousands of trials....
eu.trialstracker.net/sponsor/public…
I nearly FELL OVER when I was shown this.
Remember, our site checks reporting compliance for thousands of trials....
eu.trialstracker.net/sponsor/public…
@PHE_uk ... here is the Telegraph describing Public Health England failing to comply with trial reporting rules, and why it matters...
@PHE_uk ... very reasonably, the @CommonsSTC report is critical of @PHE_uk over their failure to comply with EU trial reporting rules (PHE are breaching on vaccine trials, where we most need to earn public trust!) The Committee asks PHE for an explanation...
publications.parliament.uk/pa/cm201719/cm…
publications.parliament.uk/pa/cm201719/cm…
@PHE_uk @CommonsSTC .. how have PHE responded so far?
They told the BBC these trials are already reported:
bbc.co.uk/news/amp/healt…
"We are committed to transparency and have already published this data publicly in academic journals and online at clinicaltrials.gov ."
...
They told the BBC these trials are already reported:
bbc.co.uk/news/amp/healt…
"We are committed to transparency and have already published this data publicly in academic journals and online at clinicaltrials.gov ."
...
@PHE_uk @CommonsSTC ...I am very sad to tell you that what PHE say here is untrue.
They have three trials breaching EU rules.
You can see them all here.
eu.trialstracker.net/sponsor/public…
One has reported in a journal. One in a conference abstract. One, the largest, is not reported anywhere....
They have three trials breaching EU rules.
You can see them all here.
eu.trialstracker.net/sponsor/public…
One has reported in a journal. One in a conference abstract. One, the largest, is not reported anywhere....
@PHE_uk @CommonsSTC ... To repeat. This is a large trial of a vaccine in 640 children sponsored by Public Health England. It is not reported on the EU register, as EU rules require. It is not even reported in grey lit, journal, conference abstract, or press release. Nowhere...
@PHE_uk @CommonsSTC ... this unreported trial by PHE finished in 2016. Today they told the BBC they have reported their results on clinicaltrials.gov. This is untrue. Here are all the studies on clinicaltrials.gov with PHE listed anywhere as sponsor. No results for any of them...
... for PHE to claim that they've posted results for their overdue EU trials on clinicaltrials.gov is simply untrue... but this is made all the more puzzling by their previous comments on these overdue trials...
.. because last month PHE told the Telegraph that the results from this trial are "still being analysed". This is a trial that completed in 2016. EU rules require that results are posted onto the EU register within 12 months of completion. This is for good reason..
.. we use the results of clinical trials to make informed choices about treatments with our patients. But we also need to comply with these laws to build trust in medicine. I take no pleasure in telling you that PHE, responsible for our vaccines programme, have breached...
.. EU rules on trial reporting. I am baffled that PHE would risk public trust in this fashion, and I am amazed by their response. The correct response in this situation, surely, is simple: "whoops, thanks, we'll get that reported immediately"....
... that is how you build public trust in vaccines, that is how you make amends for breaching EU trial reporting rules. I very much hope that PHE will change tack, report their overdue trial data, and show leadership for all academia...
.. One last thought. I realise there will be a temptation for PHE, or those who seek to defend them, to suggest that discussing their breach of EU rules will give succour to the anti-vaccine cranks. So let me be clear...
.. I did not find these unreported PHE vaccine trials. I was very upset when I was shown them by someone searching in our dataset. But we do not build trust by conspiring to silence on breaches by large public bodies...
.... There is an easy way forward: PHE comply with EU rules and report their trial results properly. The End.
But let's not forget: PHE aside, we now have amazing progress. HRA doing the right thing. EMA doing the right thing. Industry compliance skyrocketing. ONWARD!!
But let's not forget: PHE aside, we now have amazing progress. HRA doing the right thing. EMA doing the right thing. Industry compliance skyrocketing. ONWARD!!
Coda: here are some other major public bodies being GREAT on trial reporting. @iqwig @EMA_News @CommonsSTC
ebmdatalab.net/iqwig-response…
ebmdatalab.net/the-eu-trialst…
ebmdatalab.net/iqwig-response…
ebmdatalab.net/the-eu-trialst…
@iqwig @EMA_News @CommonsSTC ... Here is some follow up on yesterday's thread about trial reporting, and Public Health England breaching EU trial reporting guidelines on their vaccine trials. Since then PHE have posted the following on twitter (thread and thoughts continue below):
... It is great that @PHE_uk have responded and recognised that the issue. However I am concerned that this tweet does not address the concerns that have been raised by @CommonsSTC and my tweets yesterday. This is not just a matter of PHE breaching EU trial reporting rules...
... Of PHE's three breaching trials, most concerning is trial 2012-005273-31. This is a large clinical trial of a vaccine, conducted by PHE in 640 children, and it has not reported any results, anywhere, more than two years after its completion in October 2016...
PHE told the Telegraph, 15th September 2018 that the results of this trial were "still being analysed". Yesterday PHE told the BBC: "We are committed to transparency and have already published this data publicly in academic journals and online at clinicaltrials.gov."..
.. But here is the clinicaltrialsgov entry for PHE's unreported trial (EU trial ID 2012-005273-31) clinicaltrials.gov/ct2/show/NCT02… As you can see, contrary to what PHE told the BBC yesterday, in fact there are no results available for this trial on clinicaltrials.gov...
..I am really concerned by this. I really hope that @PHE_uk will reconsider their approach to this issue, and perhaps give @CommonsSTC and the public a clear account of what happened here, around their interactions with the media after their non-reporting was identified...
... it is absolutely understandable that there will be occasional slips in medicine, and in research. But in my view those oversights must be handled with careful thought, not with denials. We need to build trust in the national vaccines programme....
... We can only earn trust in medicine, and in the national vaccines programme, by being seen to do the right thing. I strongly support @PHE_uk. We look to them to show leadership on matters of data, evidence, transparency and trust. I hope this can all be resolved positively.
I've just had a *definitively* positive and constructive email from @PHE_uk . They are absolutely doing the right thing. Bravo bravo. Will post more after bath time (not my bath time you understand...).
Very glad to say @PHE_uk have sent a very positive and sensible email. They have also arranged to amend their earlier quote (which incorrectly stated their trial results are posted on clinicaltrials.gov)...
in addition @normanlamb has now also had a similar positive letter from @PHE_uk I think it's great that PHE are doing the right thing here. From 15 years of critical public discussion around public health and evidence this is outstanding, and rare...
I'm so happy. @PHE_uk are such an important organisation. Now they are being good again. Order is restored to the universe...
..I'd like to make one last observation in closing this epic thread. Clinical trials are huge, fiddly projects, run through with admin. Trials are all about rules. Clinical trialists are rule followers. They have huge teams of staff to handle those rules...
.. Somehow the rules about *actually reporting your results* are breached, all the time. That's bad enough. What's peculiar is that all the other rules are observed and policed with *such* spectacular obsessive force that good research is blocked...
... I want to live in an NHS where we randomise everyone, everywhere, as a matter of routine, wherever there is uncertainty about the relative benefits of treatments. I want RCTs embedded in everyday clinical care, in their thousands...
... but simple low cost pragmatic RCTs like these are blocked by trial regulations, and other foolishness. Here's a brief summary of some blockages from two UK trials I was involved in a while ago journalslibrary.nihr.ac.uk/hta/hta18430/#…
... here's the mighty Ian Roberts from LSHTM talking about ludicrous regulatory and administrative barriers to the CRASH2 trial (he's written the same about the original CRASH trial).. ...
I could go on. I have! Chapter 5 of my Bad Pharma is a howl about foolish trial regulation blocking simple important RCTs. These two editorials make the same point bmj.com/content/350/bm… bmj.com/content/349/bm…
So I'll leave you with this thought. How have we got to the insane situation where important trial regulations (like "report your results") are widely ignored; while trivial and unhelpful trial regulations are blocking vitally important work? RCT regulation needs an overhaul. End
(For more on silly trial regulation, specifically focused on the oddities of ICH-GCP, see also the MoreTrials campaign moretrials.net )
