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Posted on Sunday 12 January 2014

One thing for sure. The less you know about something, the easier it is to have an opinion. And the more you know, the harder it is to evaluate a solution. And the hardest place to be is in the middle – which is where I feel like I am with the business of Data Transparency right now, actually where I think we all are. So first to the current developments:
Pharma companies launch portal for access to trial data
AllTrials News
3rd January 2014

An online portal where researchers can request access to anonymized patient-level clinical trial data from five pharmaceutical companies has been launched at www.ClinicalStudyDataRequest.com. Last year GSK was the first company to launch an online system for researchers to request access to trial data. GSK has now been joined by Roche, Boehringer Ingelheim, Sanofi and ViiV Healthcare. The five companies are inviting all other industry, academic and non-profit trial sponsors to join them and include their studies on the portal too. 

GSK committed to making information from clinical trials since 2000 available. Sanofi announced yesterday that it will offer access to information only from trials of drugs approved after 1st January 2014. We are pleased to see the launch of the portal and that mounting pressure is bursting the banks of secrecy. But we think Sanofi can do better. Most of the medicines we use today came on the market, and were therefore tested in clinical trials, decades ago. We’re looking forward to congratulating more companies for committing to make information from past trials available this year.

About: Access to the underlying [patient level] data that are collected in clinical trials provides opportunities to conduct further research that can help advance medical science or improve patient care. This helps ensure the data provided by research participants are used to maximum effect in the creation of knowledge and understanding. Researchers can use this site to request access to anonymised patient level data and supporting documents from clinical studies to conduct further research. Study sponsors who have committed to use this site are Boehringer Ingelheim, GSK, Roche, Sanofi and ViiV Healthcare. Other clinical trial sponsors and funders are invited to join with the aim of transitioning to a fully independent system which allows access to data from clinical trials conducted by multiple companies and organisations. It is hoped that such a system will be put in place as soon as possible. If you are a study sponsor interested in listing studies on this site, contact information is provided here.

Submission: Researchers can submit research proposals and request anonymised data from clinical studies listed on this site. Study sponsors will add more studies when the site is updated. Information on sponsor’s criteria for listing studies and other relevant sponsor specific information is provided in the Study sponsors section of this site. Researchers can also submit enquiries to some study sponsors to ask about the availability of data from studies they have not listed on this site.
Find out more »

Review: Research proposals are reviewed by an Independent Review Panel. The study sponsors are not involved in the decisions made by the panel.
Find out more »

Access: Following approval and after the relevant study sponsor or sponsors receive a signed Data Sharing Agreement, access to the data needed for the research is provided on a password protected website.
Find out more »
There is a clear consensus that the Clinical Trials of drugs have been handled shamefully in the last several decades. While the trials themselves have been duly registered and conducted using the prescribed procedures [randomized, placebo controlled, double·blinded, etc.], what follows the breaking of the blind has been something of a circus. The result reporting on the registration sites has been widely ignored; many trials have not only escaped result reporting, they’ve gone unpublished; the results have been jury-rigged in more ways than one might have thought possible; and an industry of medical writers has emerged to make the results shine beyond rational interpretation. Accentuated efficacy and safety reporting has become more the rule than the exception.

The AllTrials Petition holds that the obvious solution is to make the raw, subject level data available – data as it appears when the blind is broken so that it can be analyzed independently. Some version of Data Transparency is going to happen it seems. The recent House of Commons Report is just one indicator among many. But which version? The version above is GSK’s offering that has begun to spread. First, they continue to simply not mention the why of Data Transparency, to check their work because it damned sure needs checking given the behavior industry-wide. They call it Data Sharing – so others can do further research on their data·sets [that’s called Making a Silk Purse out of a Sow’s Ear in some circles]. This is no time for this kind of make·nice talk. But their face-saving reframing doesn’t matter so much as the access to the data.

Several months back, there was an article by a GSK President Patrick Vallance and Cochrane cofounder Iain Chalmers:
Secure use of individual patient data from clinical trials
by Patrick Vallance and Iain Chalmers
The Lancet 2013 382[9898]:1073–1074.
[full text on-line]

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.

…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…
My first reaction to this article was visceral [the wisdom of the Dixie Chicks…]. It is based on patient confidentiality which feels trumped up to me. It continues leaving the control over the data in the hands of the pharmaceutical companies. It relies on the continued integrity of the trialists eg Cochrane just like we formerly relied on our academics. And frankly, the way industry has behaved, they’ve no right to bargain for anything at all. The Clinical·Study·Data·Request plan could easily be a way to pre-empt All Trials, All the Time. So I’m in no mood to see this as the final answer.

They’ve successfully co-opted every previous attempt at reform – from Kefauver in 1962 through clinicaltrials.gov, to now. We can’t let them do it again. Right now, the GSK version is being tested in action and they are on their best behavior. I’m sure that the results not just of the study, but of this process will be published. I’m thinking that at the least, there should be some binding mechanism to over-ride the decisions of the independent board if it’s being used to obstruct legitimate discovery. And I think that it should be made explicit that checking the data·analysis is a valid research project. And what about reporting on clinicaltrials.gov?

They can’t expect us to trust them. As BMJ Editor, Fiona Godlee, says, "we have to recognize that the pharmaceutical industry has an irreducible conflict of interest in relation to the way it represents its drugs, in science and in marketing."
So how about some Dixie Chicks – lite?

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