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Pfizer ups the ante on clinical transparency

Revamps access to data portal

Pfizer HQPfizer has revamped its data access portal to make it easier for patients and researchers to get information from its clinical trials.

The company has set up a new portal - iirsubmission.pfizer.com - that will allow qualified researchers to request anonymised patient-level data, but only from products that have been approved and on the market for 24 months or discontinued.

It also plans to publish synopses of clinical study reports (CSRs) going back to September 2007 - for approved products with basic results posted on the clinicaltrials.gov website - and will provide lay-language summaries of trials to participants who wish to receive them from next year "in countries where regulations permit".

The company claims to be the first pharma company to summaries of trial results directly back to participants in a lay language format, and will also pilot Blue Button technology to enable Pfizer trial participants to download their own electronic clinical data.

Blue Button was launched by the US Departments of Veterans Affairs and Health and Human Services in 2010 in an effort to improve access to patients' own health data.

"Access to clinical data empowers today's patients with information and resources to better manage their health and wellness," said Craig Lipset, head of clinical innovation at Pfizer's R&D division.

In a statement Pfizer said its proposals meet or exceed the guidelines published by the Pharmaceutical Research and Manufacturers of America (PhRMA) and European Federation of Pharmaceutical Industries and Associations (EFPIA) in July, although transparency advocates said they do not go far enough.

"While any forward movement from industry on transparency is welcome, this statement from Pfizer contains the same loopholes that we have seen from industry for many years," said Ben Goldacre, author of Bad Pharma and co-founder of the AllTrials campaign for clinical data transparency.

He criticised a number of elements in Pfizer's new policy, including the exclusion of 'off-label' studies which encourage use of drugs in unapproved indications, noting that Pfizer has been fined in the past for promoting off-label uses of several drugs.

"Since Pfizer know that these uses are commonplace, and they have promoted these uses themselves, it makes no sense for them to say the trial data on these uses should be kept secret," commented Goldacre.

The AllTrials statement also questioned the exclusion of older trials - pointing out that they concern the drugs most commonly used today - and re-iterated its position that providing only summaries of CSRs is "unacceptable".

Last month, a study by researchers at German health technology assessment (HTA) agency IQWiG concluded that summaries of trials made available by pharma companies often lack vital details on the effects and side effects of medicines which feature in the full CSRs.

Meanwhile, the European Medicines Agency is currently preparing a new policy on clinical trial data transparency that was due to come into effect on January 1 but has now been delayed as it sifts through more than 1,000 comments received during a public consultation period. The agency is scheduled to provide an update on the process after its next management board meeting next week.

"Medicine has changed, and there is an inevitable policy trajectory towards greater transparency," said Goldacre. "Pfizer should show true leadership, and recognise that their loopholes inflict unnecessary harm on industry's reputation."

Article by
Phil Taylor

6th December 2013

From: Research, Regulatory

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