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Biotech Group Issues Clinical Trial Data Sharing Guidelines

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(Bill McChesney/Flickr)

25 March 2014. Biotechnology Industry Organization (BIO) today released its principles for sharing data from clinical trials that encourage making more data available from clinical trials, but leave procedures for sharing up to the individual companies. The guidelines cover programs resulting in approved medicines, as well as those discontinued for safety or efficacy reasons, although more details will be made available for approved medicines.

BIO’s membership includes biotechnology companies, academic institutions, and state biotechnology centers in the U.S. and 30 countries, from start-up enterprises to Fortune 500 companies. The group’s members are engaged in research and development of health care, agricultural, industrial, and environmental products based on biotechnology.

The principles call for all sponsored clinical trials to listed in appropriate registries, either ClinicalTrials.gov or European Clinical Trials Database (EudraCT). BIO says its member companies now routinely register intermediate and later-stage trials with ClinicalTrials.gov, as required by the Food and Drug Administration Amendments Act of 2007.

More data will be made available for approved medications, such as Clinical Study Reports, clinical data sets to the individual patient level, and clinical study designs and protocols, to qualified researchers. Each company, however, will set its own criteria and processes, including the definition of qualified researchers.

BIO members will also make summaries of clinical trials available in databases, whether the products are approved or discontinued, or results are positive or negative. The guidelines, however, do not make a firm commitment to share summaries of clinical trials with participants in clinical trials, only to “work with regulators to adopt a framework for developing and sharing factual summaries of clinical trial results” with people taking part in trials.

The guidelines call for companies to make publish in scientific literature all results of late-stage clinical trials, and other clinical studies “of significant medical importance,” whether the findings are positive or negative. Publications can include scientific journals, professional meetings, or a company’s own Web site.

“BIO recognizes that responsible clinical trial data sharing advances public health and scientific discourse, honors research participants’ expectations of privacy through informed consent, and promotes biomedical innovation,” says BIO president Jim Greenwood in an organization statement. “These Principles reaffirm our support for these efforts, and represent a commitment to make additional information available to the public, qualified researchers, and patients participating in clinical trials.”

In July 2013, the European Federation of Pharmaceutical Industries and Associations and Pharmaceutical Research and Manufacturers of America issued joint principles for expanding access to clinical trial data for scientists and trial participants.

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