Abstract

The case discusses how UK-based pharmaceutical major, GlaxoSmithKline plc (GSK), embraced transparency and openness in October 2012 by announcing its plans to publish its clinical trials data online. With this, the pharma major planned to actively collaborate with scientists and researchers to find new drugs to treat diseases plaguing the developing world. GSK’s move to becoming more transparent with its clinical trials was greeted with a degree of cynicism be a section of industry experts who they felt that the company’s commitment to transparency resulted more from the lawsuits it faced for concealing negative data related to its drugs. In July 2012, GSK paid a fine of US$ 3 billion for illegally marketing its drugs and not disclosing data to the regulators. Notwithstanding criticisms, in October 2012, GSK announced that it would publish the results of all its clinical trials in scientific journals. In May 2013, GSK launched a web-based system through which researchers and scientists could access anonymized patient-level data upon request. The pharma major set up an independent panel of experts for reviewing and approving requests from researchers and scientists to access the data. The data transparency move was a first for a pharmaceutical company. Andrew Witty, CEO of GSK, believed that the initiative could catalyze other firms in the industry to follow suit. Industry observers believed that trial transparency could make drug development more efficient and save the pharma industry while getting breakthrough therapies quickly to patients. Some observers pointed out that GSK would, however, have to combat challenges related to its data transparency initiatives such as data misuse, maintaining patient privacy, and loss of proprietary advantage.

Learning Objectives

The case is structured to achieve the following Learning Objectives:

• Identify the factors that led to GSK committing itself to being radically open and sharing its clinical trials data publicly.
• Analyze the effectiveness of GSK’s data transparency initiatives.
• Apply a framework for implementing data transparency that respects data privacy and prevents data misuse.

Keywords

GlaxoSmithKline plc, Data transparency, Corporate transparency, Clinical trial data, Clinical Study Register, Data secrecy, Clinical study reports, Data misuse, Patient privacy, AllTrials campaign, Food and Drug Administration