• Dr Bina Rawal

    Posted in category Opinion by Dr Bina Rawal on 20/08/2013

    Clinical trial transparency: a personal view

Since starting at the ABPI nearly a year ago the issue of clinical trial transparency has been at the top of my priority list and remains a hot topic.

 

Only recently, a BBC Radio 4 presenter of a science programme stated "…there is a colossal problem, results for a staggering half of trials conducted are never published. They are just missing." From my personal experience in managing clinical trials in companies, I find that difficult to believe. Indeed, one of the first things that I did was to commission a study to establish what is true today. The findings from this study, which I hope will be published soon, show a much more encouraging picture for industry trials.

The purpose of clinical trial transparency needs to be clear – is it communication of the occurrence and results of trials to the general public or about facilitation of further research for scientists? Put simply, the answer to this question determines what you do and how. However, once you get into the detail of how to do this, it becomes a technical discussion that does not lend itself to short sound bites.

Whilst the public debate has been polarised, for example organisations have been categorised as pro or anti-transparency depending on whether they have signed up to the AllTrials campaign. In fact, taking part in discussions and workshops with people across the research community, there is a genuine willingness from all stakeholders to talk openly and get into the technical details, which is the best way to make progress.

A challenging area remains what happens with historical trial information. I have discussed this at great length with many people. Essentially, there is a trade-off between the resources it would take to go back and publish tens of thousands of trial results for the sole purpose of openness vs putting energy into sharing data in order to answer specific scientific/medical questions. My personal view is the latter offers the greatest benefit to patients.

I believe the way to achieve this is for requests for access to historical clinical study reports and/or individual patient level data should be made directly to companies, which should develop processes for handling these requests fairly.

Some companies such as GSK and Roche are setting up expert panels to assess requests that include individual patient level data sets. This is something that other companies are also looking at.

As the debate over the last year has shown – there are no quick fixes to this issue. However, I believe that the pharmaceutical industry is making progress and I am committed to support companies to become more transparent, whether this is through the production of resources such as our new clinical trial disclosure toolkit or working across the research community to find pragmatic solutions which benefit both future patients and the wider body of scientific knowledge. 


Dr Bina Rawal

Director of Research, Medical and Innovation

 
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