Publishing All Trial results: a Covenant with Patients

A recent study from the USA published in BMJ highlights an issue which has been lurking under the carpet, despite the work of the All Trials campaign.

The study looked at the publication record of academically led clinical trials in the USA. It was led by Yale University. Over 5000 trials were identified as starting between October 2007 and September 2010. A number of these were excluded leaving 4347 across 51 academic institutions to be analysed. Overall 2892 (66.5%) had been published by July 2014. The study has a comprehensive analysis by type of trial and intervention, institution etc and certainly satisfied me it had considered all the issues. It came to the sad conclusion that publication rates are very variable and there is “poor performance across leading academic medical centers in the dissemination of clinical trial results.”

The focus for All Trials has been on industry studies and great steps have been achieved. However this BMJ study shows that the academic world needs closer examination and needs to be provoked into action too. In Europe it may be less of a problem but we don’t know, we certainly cannot be sure. We have clear commitments about publishing from EORTC and from many leading academic collaborative groups, national and multi-national. Individual institutions have made commitments too but what is the real story? We don’t know. Is the positive action from the prominent few allowing others to hide away, ignoring the issue in the hope it will go away?

We don’t actually need a study like the one from the USA. We could just start to take action.

The best way of finding out would be through the registration authorities. Each sponsor should provide a simple table of studies sponsored, completion information and planned publication dates, regularly updated and made publicly available. This table could be entitled The Patient Covenant. Any sponsor (quite often these are academic bodies) which has outstanding trial publications should be unable to register any new trial until their obligations are met.

In addition any principal investigator taking a study to ethics for approval should have his study placed on hold if trial publications are outstanding. This would give a two-tier coverage and will stop institutions breaching their covenant with patients.

As patients we should be quite uncompromising about trial publication. There are no excuses for not publishing. Failure to do so violates the explicit promise made to patients entering the trial that it aims to provide clinical evidence, even failure to achieve a trial objective can still provide evidence. Not publishing impairs understanding and threatens the integrity of clinical evidence, squandering resources in doing so.

I was very taken by four verbs used in the conclusion of the study published by BMJ. Think about them. I use them above and I list them out of context below because I think it adds to their impact:

  • impairs
  • violates
  • squanders
  • threatens

If you are reading this you know the context; avoid these blistering criticisms.


This blog first published by the 26th February 2016

In praise of independence of thought

The National Archives continually releases items of interest which the press keep an eye on. This week the Times has reported on the 1982/84 correspondence which reveals that Margaret Thatcher’s government put pressure on the University of Lancaster not to award an honorary degree to Nelson Mandela. The Independent repeated the story and I have linked to them because you don’t need a subscription to read it

Mrs Thatcher had previously dismissed the African National Congress (ANC) as “a typical terrorist organisation” and refused to back sanctions against the South African government which operated the brutal separatist policy of apartheid. Everything changed of course in 1990 when apartheid fell apart and Mandela was released from prison.  No-one as far as we know ever accused Mrs Thatcher in person of being two-faced but the lady who famously said “you turn if you want to, this lady is not for turning” (another issue at another time it is true) delivered a beaming smile for the No10 doorstep handshakes when Mandela came to the UK.

However the University of Lancaster stuck to its guns. Government pressure had no effect. Although he could not be present Princess Alexandra, the University Chancellor, awarded an honorary LLD to Nelson Mandela in 1984. At that time it must have been like a small light in the dark, a symbol of hope that honesty and justice would eventually prevail.

This where I declare an interest. The University of Lancaster awarded me an honorary LLD in 2012. When I saw the list of those who had preceded me I was blown away by one name above all others, Nelson Mandela. I was privileged to be awarded the honour of the degree but to be in his company made it extra special.  When Sir Chris Bonnington, the University Chancellor, shook my hand I was thinking of my inspirational predecessor who did not have to face this grand (and slightly ludicrous) ceremony because he was behind bars.

Let us give thanks for independence of thought. It is one of our treasured freedoms and we should never be scared of using it.