It’s genuinely big news this afternoon that GSK (Glaxo-Smith-Kline) has pledged that they will publish all results of clinical study reports (CSRs) and clinical trials, not only going forward, but also going back on all approved medications developed since the year 2000.
Studies with significant or positive results were more likely to be published than those with non-significant or negative results . . .
I’ve written in the past on the reluctance of Roche to release all of their clinical trial data on Tamiflu, and in RCTs: All That’s Gold Standard Doesn’t Glitter, we looked at a Johns Hopkins Study on pediatric clinical trials that found:
Overall, 41 percent of the 146 trials in the review had improper or poorly described randomization techniques. Industry-funded trials were six times more likely to have high risk for biased randomization than government-funded trials or those funded by nonprofit organizations.
While public concerns over industry reporting bias and secrecy have grown over the years, the charge has really been led by All Trials Registered, All Results Reported.
An initiative of Sense About Science, Bad Science, BMJ, James Lind Initiative, the Centre for Evidence-based Medicine and others, their grassroots campaign has put considerable pressure on pharmaceutical companies to release their data.
Today, in what can only be described as a major victory for the AllTrials campaign, GSK posted the following announcement on their corporate website, pledging to publish detailed drug trial data.
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.
Hopefully this will be the first of many such industry announcements.