Trial data row puts regulator on the spot

EMA Highlights by Gary Finnegan – The European Medicines Agency (EMA) must perform a delicate balancing act as it finds itself centre stage in the on-going debate about the publication of clinical trial data.

As politicians debate a new EU law on clinical trials and the biopharma industry publishes fresh guidelines on data sharing, the Agency has launched an open consultation on access to files submitted in support of marketing license applications.

Transparency campaigners want all clinical trials to be registered, their results reported, and data shared with independent researchers. But the pharmaceutical industry has reservations, citing confidentiality and competition concerns.

Greater public scrutiny of clinical trials would have public health benefits, according to a discussion document circulated by the EMA. However, the regulator says it must safeguard patient confidentiality and commercially confidential information.

Disputes over access to trial data have dragged the Agency into unwanted conflicts in recent years as campaigners seek to force it to release more drug safety data. For its part, the EMA says it has released over 1.9 million pages of clinical trial data in response to safety-related requests between November 2010 and April 2013.

Industry groups have expressed a willingness to share more data with researchers and are committed to publishing clinical study reports for trials submitted to the EMA and its US counterpart, the Food and Drug Administration (FDA), provided it does not jeopardise privacy or commercial interests.

The issue is coming to a head in Europe as the Members of the European Parliament (MEPs) gears up for a crucial debate in October on a new Clinical Trials Regulation. A draft of the law has already been approved by the Parliament’s health committee which emphasised the need for greater transparency.

The new law, published more than a year ago, was designed to reverse the decline in the number of trials conducted in Europe. The 2001 EU Clinical Trials Directive which is currently in force has been the subject of severe criticism from academic and industry researchers.

Facing stiff competition from emerging markets in Asia and Latin America, EU policymakers are seeking to make it less expensive and less bureaucratic to conduct clinical research in Europe.

The issue of trial data transparency was not one of the chief concerns raised by stakeholders when the directive came up for review but it has been highlighted by MEPs and lobbyists in recent months.

Following a consultation process that runs until the autumn, the EMA is expected to publish a new policy paper on the issue by the end of the year.