GSK have just this minute announced that they are signing up to the alltrials.net campaign.
This will be written in a hurry. Briefly: the results of clinical trials have been routinely withheld from doctors and patients throughout medicine, and this problem has not been fixed. The www.alltrials.net campaign is asking for all trials to be registered, for all summary results to be reported, and for full Clinical Study Reports to be made publicly available. CSRs are important, because it is now clear that brief summaries about trials (such as academic journal articles) can be incomplete or misleading. Last Friday I met with Andrew Witty, the head of GSK, to discuss these concerns, and it was clear that they’ve spent a lot of time thinking about these issues.
I couldn’t be any happier. This is huge, and internationally huge. GSK have made a commitment to post CSRs online. They have also made sensible noises about the practicalities, which shows that they have thought about the implications, and they also discuss prioritising which CSRs to work on first. Because they have discussed these technical details – while I will always wait for the proof in the pudding – I do not believe this is mere lip service.
Dr Ben Goldacre
Read Dr Goldachre’s full response to The GSK statement.
GSK Announces Support For AllTrials Campaign For Clinical Data Transparency
Press Release Issued: Tuesday 5 February 2013, London UK
GSK today further demonstrated its commitment to clinical trial transparency by announcing its support for the AllTrials campaign. The campaign is calling for registration of clinical trials and the disclosure of clinical trial results and clinical study reports (CSRs) to help drive further scientific understanding.
GSK already publicly discloses a significant amount of information about its clinical trials. The company registers and posts summary information about each trial it begins and shares the results of all its clinical trials – whether positive or negative – on a website accessible to all. Today this website includes almost 5,000 clinical trial result summaries and receives an average of almost 11,000 visitors each month. The company has also previously committed to seek publication of the results of all of its clinical trials that evaluate its medicines to peer-reviewed scientific journals.
Expanding on this, GSK is committing to make CSRs publicly available through its clinical trials register. CSRs are formal study reports that provide more details on the design, methods and results of clinical trials and form the basis of submissions to the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and other regulatory agencies. From now, GSK will publish CSRs for all of its medicines once they have been approved or discontinued from development and the results have been published. This is to allow for the data to be first reviewed by regulators and the scientific community. Patient data in the CSRs and their appendices will be removed to ensure patient confidentiality is maintained.
In addition, while there are practical challenges, the company also intends to publish CSRs for clinical outcomes trials for all approved medicines dating back to the formation of GSK. This will require retrieval and examination of each historic CSR to remove confidential patient information. Given the significant volume of studies involved, the company will put in place a dedicated team to conduct this work which it expects to complete over a number of years. Posting will take place in a step-wise manner, with priority given to CSRs for its most commonly prescribed medicines.
Patrick Vallance, President, Pharmaceuticals R&D, GlaxoSmithKline, said: “We are committed to being transparent with our clinical trial data to help advance scientific understanding and inform medical judgment. Our commitment also acknowledges the very great contribution made by the individuals who participate in clinical research. All those involved in the conduct and publication of clinical research, whether healthcare companies like GSK, academia or research organisations, have a role to play in ensuring that the data they generate are made publicly available to help bring patient benefit.”
Separately, in October 2012, and going further than the call made by the AllTrials campaign, GSK announced it would develop a system where researchers will be able request access to detailed anonymised patient level data that sit behind the results of clinical trials to enable additional scientific inquiry and analyses to help further scientific knowledge.
GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com.
I should add one thing: AllTrials.net is asking for CSRs back to 1990. GSK have said to me that they are prioritising to the beginning of GSK’s history, as in the press release above (GSK was formed from a merger in 2001) but will also look at releasing earlier CSRs too. I hope this moves forward as well. Also, the sharing of individual patient data that they discuss is (correctly in my view, until confidentiality issues are addressed, as discussed elsewhere) on request to specific academic teams, not publicly released; and initially the data is only going back to 2007, tho GSK say they are open to requests for earlier data, which may be held in different formats and so take longer.
Anyway: bravo, really. Bravo. This is huge.
Dr Ben Goldacre
The Health-Care Survivor’s Comment
Please sign the AllTrials petition, an initiative with which I wholeheartedly agree. Without openness and discussion of all the information available, about any prescribed treatment, it will remain impossible for patients to give informed consent to, or take an active part in their treatment, or the maintenance of good health.
Thanks to Dr Ben Goldachre: Bad Science.