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Uncloaking Clinical Trials
GlaxoSmithKline will share long-sought, raw trial data—but access will be tightly controlled.
In an about-face on the issue of candor, the pharmaceutical giant GlaxoSmithKline (GSK) will systematically begin making its vast archives of clinical trial data available to researchers, the company announced last week (October 11). But the data won’t be completely accessible: GSK will still control access by assembling a panel, charged with reviewing and granting requests to view the data, to “ensure that this information will be used for valid scientific endeavor.”
In the announcement, the company—which once sided with the rest of the pharmaceutical sector by keeping all such unpublished data under lock and key —explained the philosophical flip by stating that a data release will “enable additional scientific inquiry and analyses to further scientific knowledge and help bring benefit to patients.” The decision comes in the wake of several trial-related scandals by big pharmaceutical companies over the past decade, including one earlier this year in which GSK paid a whopping $3 billion settlement to US authorities for—in part—obfuscating clinical trial results.
The new access has some GSK researchers and academic scientists hopeful of greater transparency and collaboration in the future. ...others are wary of the restrictions and hesitant to laud GSK until it’s clear how accessible and detailed the released data will be.
“Let’s wait and see,” Kay Dickersin, director of the Center for Clinical Trials at the Johns Hopkins University told Nature. Dickersin warned that the real value of such a reveal would be determined by the details of the data sets, including the patient-level information, the trial design, and analysis explanation—aspects GSK has not explicitly stated will be available.
But the data won’t be completely accessible: GSK will still control access by assembling a panel, charged with reviewing and granting requests to view the data, to “ensure that this information will be used for valid scientific endeavor.”
3-D DNA Printers: Download Meds, Vaccines
J. Craig Venter, who won awards for cracking the human genetic code back in 2000 and hit the headlines again in 2010 when he and colleagues created the first self-replicating cell with a synthetic genome, now is testing 3-D DNA printers.
Designed for “biological teleportation,” these printers could let us download our meds - and potentially, neutralize threats of epidemics and pandemics.
The famed geneticist says his team is testing 3-D DNA printers …
… (a) digital biological converter—designed for what Venter calls “biological teleportation” …
“Imagine being able to download a vaccine or your medicine on your computer at home,” …
"That's the not-to-distant future, and it wipes out the possibility of an epidemic."
Venter Supports DNA Printers