BIO, Following PhRMA and EFPIA, Releases Clinical Trial Data Transparency Plan

Posted 26 March 2014 | By Alexander Gaffney, RAC 

The Biotechnology Industry Organization (BIO) has announced that its member companies will soon grant wider access to clinical data, mirroring recent and similar efforts made by the pharmaceutical industry but falling short of calls made by transparency campaigners.


In recent years, a growing number of voices have been clamoring for greater transparency of clinical trials results, largely after some companies were found to have hidden unfavorable data regarding the safety of drugs which were later recalled.

In the US, these efforts have seen some success thanks to legislation passed to require basic trials data to be published to, as well as lawsuits against companies that have resulted in some formerly-secret trials results being released. Despite the success of the website, however, the top-line results of many trials are still never made public, and raw trials data is almost never released.

However, thanks to campaigners in the EU, the European Medicines Agency (EMA) has recently been forging ahead with an ambitious proposal that would require much more in-depth reporting of clinical trials data. That data would need to be released regardless of the approval status of the drug.

Perhaps wary of similar efforts gaining ground in the US, two major pharmaceutical industry trade groups-the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA)-announced in July 2013 that they and their member companies would be adopting their own transparency plans.

The industry plans called for access to clinical trials data, but for that data to be limited to "qualified scientific and medical researchers" to prevent data from being misused or misinterpreted. The goal was to encourage "legitimate research" as defined by each member company, PhRMA and EFPIA said in a statement.

New BIO Plan

But PhRMA and EFPIA are both primarily concerned with manufacturers of chemical drugs-not manufacturers of biological therapies and treatments.

BIO, however, is concerned with those companies, and today unveiled its own plan for facilitating more access to clinical trials data.

In its Principles on Clinical Trial Data Sharing, BIO puts forth a plan that is similar in many respects to the one put forth by PhRMA and EFPIA. Companies would be tasked with publishing clinical trials data (such as in scientific journals), providing summarized results of almost all trials regardless of their outcome (all trials for approved drugs; all pivotal trials for unapproved drugs), and providing factual summaries of trial data to research participants.

Most important of all, BIO member companies will be charged will fulfilling "qualified requests from medical and scientific researchers for additional clinical trial data beyond those shared proactively with the public," it wrote. Those requests would be evaluated by each member company according to its own "criteria, procedures and timelines-not independent experts, as required under the PhRMA plan.

BIO added that companies are free to go above and beyond its basic principles as well. "We view the commitments outlined in these Principles as the opening of a dialogue that will grow and evolve with shared experience," it said. "We are and will remain committed to working with the broader scientific community to develop knowledge that will improve drug development, enhance public health, and reinforce public confidence in the safety and efficacy of our medicines."


BIO Statement

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