GSK provides update on clinical trial plans

GlaxoSmithKline (GSK) is planning to release an online system of patient level data from GSK clinical trials to boost scientific understanding.

A panel of independent experts will evaluate research proposals for access to anonymised patient level data, with the work progressing towards a broader system of multiple organisations through an independent data custodian.

GSK explained that researchers can request access by providing a scientific protocol with a commitment to publish their findings, with external independent specialists appointed by GSK to advise on the system’s development.

Access to the data from GSK’s studies will be supplied on a password-protected website, protecting the research participants’ privacy and ensure the data is used for the approved scientific purpose.

The system will be run by an independent third party, which would be responsible for appointing and overseeing a review panel to access research proposals.

GSK is in discussions with interested parties to encourage the development of the system.

Patrick Vallance, GSK’s president of pharmaceuticals R&D, said: “When people volunteer for clinical trials they expect that the results will be used to help others. We are absolutely committed to sharing data so that researchers can examine the details more closely, do their own analyses and learn more about medicines and how they can best be used.

“Consistent with good scientific practice, researchers will be required to submit a research plan and to commit to transparency in the publication of their work.”

Mr Vallance explained that GSK is the first organisation to develop a system for sharing detailed clinical data, adding that he wants to see such a system put in place by a third party as soon as possible.

Over recent years, GSK has taken a number of measures to share information from clinical trials, with results of the work being made available on a website for all users to see.