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Regulatory Focus™ > News Articles > Industry Pledges Tentative Support for Clinical Trials Data Transparency

Industry Pledges Tentative Support for Clinical Trials Data Transparency

Posted 14 November 2012 | By

Greater transparency of clinical trials data has long been the goal of many academic researchers, who claim withheld data can often mask troubling safety issues. Now, those researchers are being joined by an unlikely ally: industry.

Manufacturing giant GlaxoSmithKline made headlines in October 2012 when it announced it would shift to a new transparency model in which it would allow select researchers to access trials data.

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

"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.

Now, an old partner is reiterating its support for transparency measures. In a 14 November 2012 statement, the European Federation of Pharmaceutical industries and Associations (EFPIA), the top pharmaceutical industry association in Europe, said it supported "improved transparency."

"As a global industry, we are focused on working toward responsible transparency, as shown by the commitments already made. Building on these initiatives, we recognize and take seriously our responsibility to lead in advancing transparency, and propose that this needs to be part of a comprehensive initiative involving all stakeholders."

Unlike GSK, however, EFPIA reiterated concerns raised earlier in a July 2012 position paper that too much transparency could be bad for the industry and, ultimately, patients as well. "We believe it is both feasible and necessary to balance the needs of personal privacy and commercial confidentiality while providing the level of transparency needed to support public health decision-making," it wrote.

EFPIA also noted that many products are currently protected not by patents, but by regulatory data. "It would be damaging to companies if competitors could circumvent this by printing all the data from the Internet," EFPIA's implication being that it would hurt investment in new therapies.

EFPIA's statement comes just as the European Commission is preparing to revisit the Clinical Trials Directive (CTD) to see if additional transparency measures can be institutionalized. Officials from the European Medicines Agency (EMA) have already expressed support for the measure, and new initiatives from the British Medical Journaland publicity surrounding a new book from medical author Ben Goldacre have given the transparency movement a high level of visibility.

At this point, industry said all it wants is a seat at the table to discuss these issues. "This is a larger debate than transparency alone and no stakeholder should be left out of the debate," wrote EFPIA. "We strongly believe that it is not possible to get the best possible legislation without everyone at the table, to ensure that citizens and patient throughout the EU have the highest quality of medicines possible."

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