1 Boring Old Man

Chair: So you are arguing in favour of full release of information. What impact do you think that would have on the pharmaceutical industry?

Tracey Brown: When you say full release of information, I should just clarify that. It is helpful to think of this at four levels. One is the registration of trials; that is level 1. That has been a problem, certainly historically, although there have been some improvements since the 2007 FDA regulations and other interventions. We do not even have the contents list, if you like, of what has been done, never mind being able to track down some of the results. That is something that reviewers who are looking across a whole range of studies really struggle with; they spend a lot of time just trying to find out what has actually been done but been left in a cupboard somewhere. Registration is about knowing what the trial is for and registering the protocols.

The second level of information, which is what AllTrials is calling for, is the basic summary of the clinical study report. That says what was actually found, what the primary outcomes were and what the protocols were. We would like to see as much information there as possible, but that certainly gives you some indication of what research has been done and how it has been undertaken.

The area for quite a lot of discussion at the moment is what I would call level 3, which is the full clinical study report. That contains in many cases quite a lot. It is a very large report-quite often, it even runs to thousands of pages-and it may contain quite a lot of individual patient data, things that might be tracked to individual patients or other things that constitute reasons why people might be concerned. There is a discussion about the release of those. I just note that we are seeing their release by the European Medicines Agency already for those drugs that they have them for.

Then there is the fourth level, which is individual patient data. A lot of very productive discussion is going on about how to establish good protocols for sharing that among the research community-for example, setting out the same requirements for secondary research as you would for primary research, looking at the same data…

Pamela Nash: Ms Brown, just to be clear, is the aim of the AllTrials campaign to have all four levels published?

Tracey Brown: No, the aim of the AllTrials campaign is to ensure that levels 1 and 2 are published. Levels 1 and 2 do not have a huge amount of practical implication. It’s just a shocker that they are not published already. Levels 3 and 4-level 4 particularly has a certain practical implication, depending on the organisation. The requirements of level 3 – what would be an equivalent to a clinical study report; there are such things, but for an academic, for example-just need to be ironed out and worked on. It is not a huge barrier to publishing that information. There is quite important information at level 3 about serious adverse events, for example, that may need to be shared, but that just takes a little more work and thinking about.

We are really pleased that, in signing up to AllTrials, GlaxoSmithKline, for example, committed to publishing a lot of their level 3 data. Obviously, we are going to look at what they encounter in doing that. That is an ongoing discussion with them. A lot of the people who have signed up to AllTrials are committed to that, too, but what we want to do is just to get past the idea that secrecy is okay. That is really the ultimate aim ofAllTrials. It is just to find out what people have done and what they have found, at a very basic level, and then we can go on to look at some of the implications of sharing that…

I don’t trust PHARMA, period. Besides the string of regular misbehavior with Clinical Trial Data reaching back over the last two decades, there’s been an aggressive campaign to undermine Data Transparency in the recent past:

• the leaked memo [in the shadows…]
• their Trade Commission letter [see an ill-gotten fortune…]
• the AbbVie/InterMune suit
• the PhRMA/EFPIA conference in Brussels [see a deal-breaker?…]
• the article [Intellectual Property Protections Are Vital to Continuing Innovation in the Biopharmaceutical Industry]
• the EMA U Turn [see a crushing setback… and some further information…]

• the a priori protocol with all legitimate ammendments;
• the raw data tables abstracted before the blind is broken [with the unblinding key];
• access to the original CRFs to check the AEs;