by Patrick Vallance and Iain ChalmersThe Lancet 2013 382[9898]:1073 – 1074.
Publishing the results of all clinical trials, whoever funds them, is required for ethical, scientific, economic, and societal reasons. Individuals who take part in trials need to be sure that data they contribute are used to further knowledge, prevent unnecessary duplication of research, and improve the prospects for patients.Endorsement of these principles is clear in the support received for the UK-based charitable trust Sense about Science’s campaign demanding that all clinical trials should be registered and reported. However, although the campaign recognises the advantages of analyses based on individual participant data (IPD), it is not calling for open access to IPD. The campaign recognises that risks to personal privacy must be taken seriously. These risks are not just theoretical: a recent study was able to identify 50 individuals from public websites that contained genetic information. The research community must work with others to define what constitutes appropriate protection of identifiable information if it is to retain public trust in the use of IPD.
Analyses based on IPD have many advantages. In 1970, The Lancet published a report based on nine trials of anticoagulant therapy after myocardial infarction. That study showed how, compared with analyses of aggregate data, access to IPD facilitated more thorough data checking; identified missing information; prompted renewed searches for key outcomes; enabled longitudinal analyses based on serial measurements in individuals; and offered greater reliability of subgroup analyses. Nearly two decades passed before others began to collaborate widely to use IPD analyses. These initiatives from collaborative trialists’ groups resulted in authoritative analyses of direct relevance to patient care in cancer and cardiovascular diseases, among others. The advantages of IPD analyses have prompted calls for wider access to such data, and we support these calls. However, robust arrangements are needed to minimise the risks of breaches of patient confidentiality. The experience gained within trialists’ collaborations is important, since, as far as we are aware, they have an unbroken record of maintaining patient confidentiality in their IPD analyses…
PV is a President at GlaxoSmithKline, holds stock or stock options in GlaxoSmithKline, and is a board member of A*Star Board Singapore and Genome Research Limited. IC declares that he has no conflicts of interest. The authors would like to thank Martin Bobrow, Mike Clarke, and Ben Goldacre for helpful comments and critical review of this Comment.
So why would Iain Chalmers and Ben Goldacre put their names on this article that feels so much like a Trojan Horse? Having looked at GSK’s proposed process for access myself, it gives GSK the choice of releasing the data based on the credentials of the applicant and GSK’s opinion of the worthiness of their research proposal. I don’t want access to their IPDs to do further research. I want it to check and see if they’re cheating again like they’ve done countless times before. This article talks about the problem’s solution without mentioning what the problem is. It doesn’t mention the gross corruption in the publication of Clinical Trial results, and the epidemic of jury-rigged or absent trials that have turned our literature into litter-ature. It implies that we want data transparency to further scientific exploration. That’s a worthy goal, but off the point. So why would Iain Chalmers and Ben Goldacre put their names on this article that feels so much like a Trojan Horse? I don’t know the answer to that. Perhaps they can tell us why this isn’t a sell-out:
I’m not ready to make nice
I’m not ready to back down
I’m still mad as hell and
I don’t have time to go round and round and round
It’s too late to make it right
I probably wouldn’t if I could
‘Cause I’m mad as hell
Can’t bring myself to do what it is you think I should
Access to data is paramount including after market adverse events as seen in this link:
http://pharmagossip.blogspot.com/2013/10/essure-birth-control-woman-dies-doctor.html?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+blogspot%2FDlJuM+%28PharmaGossip%29
With such small sample sizes, and cherry picked test subjects, looking at the post marketing data may in fact give us a better concept of tolerances and real world impact.
Steve Lucas
Nice use of the video at the end. Did the same with my last post just finished and then came here. Time to reboot, the masses just are not attentive.
Cue Holiday Road by Lindsay Buckingham…(like the dog barking at the end)
1bom,
Why the Chalmers piece and this:
http://www.bmj.com/content/347/bmj.f5164
appear to contradict each other is confusing.
I hope you can get Goldacre, or one of them, to clarify.
The BMJ and Lancet commentaries that I authored/co-authored addressed different issues, so I am confused by the suggestion that they contradict each other. The one in the BMJ is about universal regstration at trial inception, which should now, at last, be achieved in the UK. The Lancet piece is about the analyses based on individual patient data (IPD) from similar trials after trial completion. We noted that among other advantages, access to IPD facilitates “more thorough data checking” and identification of “missing information”. This includes “checking on whether trialists are cheating”, and some IPD analyses have detected this.
In deciding how best to make IPD available for data and other checks and reliable re-analyses the logical starting place is the substantial experience acquired during nearly three decades of IPD analyses done by various collaborative trialists’ groups. That experience is important not only in illustrating the advantages of IPD analyses, but also in showing how the privacy of individual patients can be assured.
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