GlaxoSmithKline exec details expectations for online clinical trial research

GlaxoSmithKline turned on a highly anticipated website on Tuesday that serves as a conduit for authorized researchers to tap clinical study data on certain drugs from the London-based pharma giant. As FierceBiotech reported, the effort behind the website put GSK on the forefront of transparency in pharma and spurred skepticism from critics about the process for releasing anonymous patient-level data from its vaults.

Glaxo ($GSK) has established a group of "independent" reviewers to consider requests from researchers to study the clinical data. Now that the website is live, the company has a mechanism for accepting and researchers have a mechanism for making requests for information. It's too early to say how smoothly the system will work because the site has been online for only a couple of days. Yet in an interview with FierceBiotechIT, Perry Nisen, GSK's senior vice president of science and innovation, shed some light on what researchers can expect after they make requests for data. The website itself also contains details and a sign-in function to enable researchers to get started.

What kinds of analyses should the data enable researchers to perform?

Nisen: There are all sorts of studies and approaches that people could take. They could revalidate work that we've reported. They can analyze the data in their own different ways. They might use the primary data to interrogate and help validate the methodologies that they are using. They might test questions about measures in changes in disease. They might compare and contrast that with other studies and other molecules they know about. Ultimately, it'll be great to compare and contrast those data with other primary data, to do the types of meta-analyses that people are interested in, but that will take the next stage of others being able to contribute their data.

How long should researchers expect to wait for determinations on their requests?

Nisen: We anticipate that we will get a panel decision within a month of the submitted research proposal.

What kind of support will researchers get from GSK to use the data?

Nisen: We're going to make software packages available for others to use at our cost for them to be able to access and do the studies they want to do. We will also have a help line with real people to assist researchers in navigating the data. To interrogate these data, researchers are going to need people with statistical expertise. We'll help them get started. It's massive amounts of information, and to put that in forms that are usable … is quite complex and difficult, so we've annotated all of that, put together the website for that and the systems that enable those sorts of complex analyses. It's quite a considerable investment.

As Glaxo explains online, the website includes data from about 200 clinical studies from as far back as 2007, with plans to add studies from as early as 2000, when the company formed through the merger of Glaxo Wellcome and SmithKline Beecham, over the next two years. We'll see which drug giants follow in GSK's footsteps and release their clinical data. None have announced anything as ambitious since GSK declared its plans in September.

- get more from GSK's site
- check out FierceBiotech's take

Editor's note: The Q&A portion of this article was edited for clarity and length.

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