In what is possibly the first major step to introduce transparency into drug research,
GlaxoSmithKline announced it would make detailed data from all its global
clinical trials public. The company spokesperson told
Business Today that the new system would enable researchers to "request access to anonymised patient-level data that sit behind the results of clinical trials."
The system, named "SHARE" was launched in May. The aim is to improve patient care, scientific research, and acquire a broader understanding of new and current medicines.
GSK has already received a small number of enquiries about the data. "Consistent with expectations of good scientific practice, when researchers request access to the data, they need to provide a scientific protocol and a commitment to publish their findings," the spokesperson added.
The access to data from GSK's studies will be provided on a password protected website to help protect research participants' privacy. This will also ensure that the data is being used for the approved scientific purpose. "There are approximately 200 studies currently listed and we estimate that there will be 400 studies listed on the website by the end of the year," she said. In all, there are about 1,000 trials on 90 drugs conducted by GSK since the year 2000.
On the way forward, she said the company "would like to transition to a broader independent system to allow access to data from trials conducted by multiple companies and organisations." GSK wants the same system to be introduced by a third party in the public or charitable sector as well. It was engaged in discussions for such an implementation, the spokesperson revealed.
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