James Shannon is a member of the Royal College of Physicians and has been our chief medical officer since May 2012. Here he talks about our commitment to share our research data, a policy we hope will improve confidence in our products and help to progress science.
Studying experimental medicines in people is a vital part of the development process for all new medicines and vaccines. At GSK we recognise the importance of publicly disclosing this research and in recent years have made a number of commitments to share information from our clinical trials. Back in 2004 we introduced our publicly accessible Cinical Study Register online – a place where we could post information about the clinical research we carry out on our existing medicines and also the ones that we are developing. We were the first pharmaceutical company to do this. Today this register includes close to 4,500 summaries of our clinical studies and receives an average of almost 10,000 visitors each month.Our trial results are made public regardless of whether they reflect positively or negatively on our medicines. When a trial begins we post onto our study register a protocol, which summarises the study’s objectives and design. Once the trial has completed, we provide a summary of the results. This is the case for all clinical research about our medicines. In addition to posting information to the register, we have also committed to seek publication of the results of all our clinical research on our medicines in peer-reviewed scientific journals. If a study is not published, because for example, an independent journal does not accept our proposed publication, we provide additional information on our online register to supplement the summary of results. Building on these existing commitments to openness and transparency, in October 2012 we announced plans to create a system enabling researchers to access the anonymised patient-level data that sits behind the results from our clinical trials of our approved medicines and discontinued investigational medicines.
To be sure this information is not misused, which could be detrimental to medical science and patient care, research requests will need to be submitted with proposals, which will be reviewed for scientific merit by an independent panel of experts. If approved, access to the data will be granted via a secure web site. This will enable researchers to conduct further research. This initiative is a step towards the ultimate aim of the clinical research community developing a broader system where researchers will be able to access data from clinical trials conducted by different sponsors. We hope the experience gained through our initiative will be of value in developing this wider approach. We want to be transparent, while recognising that as a commercial business there are some things that we can’t share. However, we are committed to enabling the scientific community to learn from what we know, providing information to support ongoing research and giving patients and health professionals more confidence in the data that support our medicines.
When I discovered that the raw data from Paxil Study 329 was available on the Internet in August, my interests wouldn’t have passed their criteria for "scientific merit." I wasn’t a researcher wanting to conduct "further research." I wanted to check their work because I didn’t believe their article was the truth about what the data said. I didn’t think they had fabricated or falsified the numbers. I suspected that the published analyses "spun" its meaning. I wanted to check their work because I didn’t trust them. When Dr. Nissen did his meta-analysis of the Avandia Clinical Trials, his goal might’ve been closer to "further research" because he was looking for the incidence of specific adverse effects [heart attacks], but his motive was just like mine – mistrust. And, indeed, it turned out that GSK had two damning Avandia trials that had never been reported.
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