Boehringer Ingelheim increases access to clinical trial data

Boehringer Ingelheim has become the latest drug company to commit to releasing full data it holds on the clinical trials it has conducted on its products once they are approved or after their development has been abandoned.

In an announcement on 12 May the German company said that researchers will be able to request clinical study reports and other clinical documents, including de-identified patient level study data, through its website (trials.boehringer-ingelheim.com/trial_results.html).

The requests will have to be approved by an independent external review panel, and researchers will have to sign a data sharing agreement in which they promise to use the data only for the purpose of the study proposal, not try to identify study participants, not misuse the data, and be “transparent” regarding the planned analysis and disclosure of results.

GlaxoSmithKline, Roche, and Pfizer have all made similar announcements about opening their clinical trial data vaults to researchers in the past year or two. All have retained the option to deny access.

Boehringer Ingelheim has gone beyond what is required of it under an agreement on responsible clinical trial data sharing published last July by the two largest trade bodies representing the drug industry, the European Federation of Pharmaceutical Industries and Associations and the Pharmaceutical Research and Manufacturers of America.1

The principles, which came into effect in January, promised that biopharmaceutical companies would dramatically increase the amount of information available to researchers, patients, and members of the public. But they did not require registration of old studies. Similarly, European Union governments agreed in December to pass legislation for compulsory prior registration of all EU trials to be registered on the publicly accessible EU database and their results made publicly available.2

Boehringer Ingelheim said that it would register protocol information for all types of clinical studies dating back to 1998 on ClinicalTrials.gov, including phase I studies involving healthy volunteers as well as uncontrolled and non-interventional studies of all prescription and non-prescription drugs performed anywhere in the world. The company has also committed to posting on ClinicalTrials.gov the results of studies that are approved for use only outside the United States and for drugs that have been abandoned, starting with those studies that complete in 2014.

Christopher Corsico, Boehringer Ingelheim’s global clinical development, medicine, and regulatory head, said, “The free exchange of scientific information is the basis for innovation in medicine. Boehringer Ingelheim as a research driven pharmaceutical company is committed to the registration of all clinical studies prior to initiation and to disclosing all study results independent of outcome. Going beyond applicable regulatory and legal requirements, we at Boehringer Ingelheim feel it is the right approach and hope it will benefit science.”

A spokesperson for AllTrials (www.alltrials.net),the campaign for disclosure of all trial data,3 said, “The tide is turning. With this move, especially the pledge to register trials back to 1998, Boehringer are clearly acknowledging the need for better access to past trials: these are the trials that matter the most, as they are the ones conducted on the treatments in use today. Other companies should follow suit. The era of secrecy has harmed patients and must end.”