Regulatory Focus™ > News Articles > In Shift, GSK to Publish Clinical Trials Data

In Shift, GSK to Publish Clinical Trials Data

Posted 11 October 2012

Under fire from industry critics, UK drug manufacturing giant GlakoSmithKline has announced its intent to publish clinical trials data-a first for both the company and the pharmaceutical industry, which has historically guarded such data closely to limit potential risk.

In a statement, the company said it intends to share, "Detailed clinical trial data to enable additional scientific inquiry and analyses to further scientific knowledge and help bring benefit to patients."

"As a truly global healthcare company, I believe we have a responsibility to do all we can at GSK to use our resources, knowledge and expertise to help tackle serious global health challenges," added Sir Andrew Witty, CEO of GSK.

Witty explained that by sharing clinical data, the company hopes to foster scientific progress by cutting down on the number of trials that would otherwise need to be conducted.

The company has come under criticism for its handling of clinical trials data in the past, in particular for its drugs Avandia (rosiglitazone) and Paxil (paroxetine), both of which infamously hid or misreported clinical trials data.  Though both drugs remain on the market, their usage has been curtailed based on their safety risks.

A New Transparency System

GSK said its new clinical trials data transparency system will allow researchers to access detailed, anonymized patient-level data for all approved and discontinued investigational medicines. Requests for data will be screened by GSK to, "Ensure that this information will be used for valid scientific endeavor," and made available only through a secure website, it said.

The company did not mention if the data for all existing medicines would be made available through the scheme or if it would only apply to medicines approved in the future.

It also remains unclear whether the move will be seen as a harbinger of things to come, or simply a one-off experiment. The transparency measure could, by some accounts, bring pressure on other companies to institute similar policies or be seen as obfuscating-or worse, hiding-data to the detriment of public research.

In a statement to the New York Times, former US Food and Drug Administration (FDA) deputy commissioner Joshua Sharfstein said the move could, if widely adopted, allow companies to reduce their expenditures on clinical trials research, which can constitute the bulk of a company's R&D budget. "Making data available, particularly on the products that didn't succeed, could avoid others having to learn the same lessons," he said.

Will Researchers Actually Receive Access?

Others, including prominent Cleveland Clinic cardiologist Steven Nissen, famous for uncovering the then-unknown risks of GSK's Avandia, said he was skeptical what amount of access researchers will be allowed, especially once concerns are raised about a drug's safety.

"Would someone who wants to take a critical look at an existing drug on the market be granted access?" he mused.

GSK, for its part, said the data would be made available regardless of its implications for the company's bottom line. "We've been caught by some things in the past - I think we want to be clear on this," he said.

GSK also said it was in the process of making its tuberculosis drug compound library freely available to the public. The company said the compounds are comprised of 200 drugs with "demonstrated signs of activity against TB"-a first for any pharmaceutical company, it said.

"It is hoped this will encourage others to pursue a fully open approach to research into a disease that causes around 1.5 million deaths around the world every year," the company explained.


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