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EMA defends position on patient-level data

Regulator claims pharma industry fears over transparency are unfounded

The European Medicines Agency (EMA) has hit back at industry criticism of its clinical trial transparency push in an editorial published in the New England Journal of Medicine (NEJM).

Four senior agency figures led by executive director Guido Rasi write in the editorial that the pharma industry's fears about revealing anonymised patient-level data - in particular that trade secrets will be up for grabs - are unfounded.

"We argue that access to full - though appropriately de-identified - data sets from clinical trials will benefit the research-based biopharmaceutical industry," according to the authors.

"We predict that it will help to increase the efficiency of drug development, improve cost-effectiveness, improve comparative-effectiveness analysis, and reduce duplication of effort among trial sponsors," they add.

There is growing pressure for greater transparency in clinical trial results, with the European Association of Hospital Pharmacists (EAHP), Germany's health technology assessment agency IQWIG and UK Members of Parliament all adding their voices to the debate in recent weeks.  IQWIG and EAHP have also signed up to the AllTrials campaign.

Rasi et al argue in the article that access to full data sets of completed studies will help improve the design and analysis of subsequent trials, while access to quality-controlled databases of data could "suggest that a trial is not needed because of the weight of existing evidence."

They also suggest lessons learnt from past trials about the heterogeneity of treatment effects will streamline drug development and also enhance the value of a medicine in the marketplace, as identifying patient populations with a high unmet need could make the new medicine more cost-effective than other available treatment options.

Meanwhile, new drug sponsors of trials may be able to present more robust comparative efficacy information soon after licensing that could avoid the need for costly head-to-head studies and make reimbursement negotiations go more quickly.

The EMA figures also claim that industry's concern that data could be misinterpreted is not justified because the risk of that happening with secondary analysis exists "regardless of the nature of the data."

"A managed-release environment that allows sharing of patient-level data while ensuring patient privacy would create a level playing field for all stakeholders," they concluded.

The EMA closed a three month consultation on clinical trial transparency on September 30 and is due to start implementing its proposals on January 1, 2014.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) in September took issue with a number of points in the EMA's draft proposal, which divides clinical data into three categories of access: confidential information; open-access data without patient information; and controlled-access data with patient information.

The trade body claimed in a position paper that EMA's draft plan would compromise patient confidentiality, undermine trust in the regulatory approval system and weaken incentives for companies to invest in biomedical research.

Article by
Phil Taylor

23rd October 2013

From: Research, Regulatory



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